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| Name | Class |
|---|---|
| University of Southern California | OTHER |
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Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St. Louis Children's Hospital (SLCH) who were hospitalized in a private NICU room were recruited. The parents of infants in the sensory-based intervention group were educated and supported by trained therapists to give different positive sensory experiences to their infants while hospitalized. The traditional care group received normal, standard care while hospitalized. For both care groups, infant neurobehavior, sensory processing, and parent mental health were measured at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year (corrected). Differences between the two groups were explored.
Approximately 12%, or 500,000 infants, are born preterm each year in the United States alone. Although survival rates of preterm infants have increased with advances in medical care, the risk of developmental delay and disability has remained constant. Very preterm infants (<32 weeks gestation) necessitate care in the neonatal intensive care unit (NICU) for an average of three months after birth, which is a significant period of time coinciding with a critical window of brain development. While medical factors, such as brain injury, can heighten the risk of adverse neurodevelopmental outcome, the NICU environment may also have deleterious effects on early brain structure and function.
The Influence of Early Environment: Maternal deprivation and isolation from positive sensory experiences are prominent features of orphan studies. Consequences of language and human deprivation include emotional disturbances, delayed cognitive and language skills, and abnormalities evident on magnetic resonance imaging (MRI). Although the preterm infant differs from a child who has been institutionalized or deprived of caregiving attention after full term birth, there are similarities, such as the altered temporal lobe structures, and the pattern of developmental impairments. There is growing evidence supporting the importance of parents in the NICU. Low frequency visits between parents and their hospitalized preterm infants have been associated with suboptimal outcomes, like child abuse and abandonment and adverse emotional functioning. NICU's in Sweden have been successful with engaging parents in care from admission to discharge and have reported shorter hospitalizations. There is also a growing body of evidence supporting positive sensory exposures for preterm infants, including maternal voice recordings, massage, skin-to-skin holding, and vestibular and kinesthetic interventions. In addition, my team has made important research findings pointing to the potential need for developmentally-appropriate sensory exposures in the NICU.
Outcomes Associated with Preterm Birth: While advances in medical technologies have improved the rates of survival among preterm infants, the risk of long-term morbidities remains high, with 50-70% of very preterm infants exhibiting developmental problems. In addition to motor problems, language and communication problems are common in former preterm infants when studied at school age, and recent evidence suggests that language deficits persist through childhood. Language difficulties have also been shown to affect a broad range of factors important for social prowess and academic achievement. In addition, preterm infants have a heightened risk of attachment disorders and other social-emotional problems.
Outcomes Associated with Parenting a Preterm Infant: Many negative psychological sequelae are associated with parenting a preterm infant, including depression, anxiety, and post-traumatic stress. Such negative parental mental health outcomes proceed to influence the parent-child relationship, leading to a parent's inability to recognize infant cues as well as increased negativity and intrusiveness. Negative maternal-child interactions continue into the first several months of life if stress remains high. Forming such a foundation may then lead to negative child outcomes associated with social-emotional development, including attachment insecurity, and mental health issues.
Sensory Stimuli and Current Practice in the NICU: High-risk infants who receive care in the NICU are exposed to significant stressors that include painful procedures, disruption of normal sensory experiences, and stress related to parent-infant separation. In addition to the loss of parental nurturing, there is growing concern that stress during a period of extensive brain development may result in permanent and deleterious developmental outcomes.
Developmental care, which includes sensory minimization, has been the predominant model of care in the NICU since the 1980s, because the bright and noisy environment, which exceeds sensory standards set by the American Academy of Pediatrics, is understood to adversely affect growth and development of the preterm infant. In support of developmental care principles, NICU staff makes efforts to reduce modifiable stimuli to the high-risk infant in the NICU. However, there is emerging research on the positive effects of sensory stimulation for preterm infants in the NICU.
Positive sensory exposures in the NICU are critical, as they can have life-long implications on learning, memory, emotions, and developmental progression. In an environment where stimuli are primarily negative, it is especially important to define and implement positive sensory exposures in the NICU. Further, it is well understood that multi-dimensional sensory exposures are present in utero in the final months and weeks of pregnancy, but the preterm infant misses potentially important, timed exposures that may be absent or altered in the NICU environment. Positive forms of sensory exposure during periods of infant readiness may be important to facilitate appropriate neural pathways and enable positive experiences.
Results from a rigorous systematic review, benchmarking, and expert opinion were used to develop a clinical practice guideline for sensory-based interventions for hospitalized, very preterm infants using the Appraisal of Guidelines for Research and Evaluation II instrument. The manualized intervention (from the integrative review and development of the implementation plan) includes evidenced-based interventions that can be conducted by parents with their preterm infants across postmenstrual age while hospitalized. The sensory-based intervention includes the provision of specific amounts of auditory, tactile, vestibular, kinesthetic, olfactory, and visual exposure to be conducted daily through hospitalization. The intervention plan is intended to be implemented by parents (when available) and by surrogates when the parents are unable to be present in the hospital. Surveys, focus groups of a multidisciplinary team of health care professionals and parents of preterm infants in the NICU, and a pilot/feasibility study were conducted to assess acceptability, appropriateness and feasibility of the sensory-based intervention plan. The investigators enrolled 30 very preterm infants within the first week of life and implemented the sensory-based program. Logging sheets were placed at the infant's bedside to document the execution of sensory-based interventions, who conducted the intervention (parent, member of research team or other caregiver), and infant responses and consequences of the intervention. Physiological (such as heart rate and oxygen saturation fluctuations), state (levels of arousal) and behavioral (such as crying, changes in motoric tone) responses were recorded by caregivers during interventions on the bedside logs. Negative sequelae of the intervention resulted in stopping the intervention and modifying the criteria for sensory-based interventions accordingly. A licensed therapist provided guidance as to when infants can and cannot tolerate sensory exposures. From clinical documentation and bedside logging, implementation factors were assessed. Adaptations to the sensory-based program were made until it was deemed appropriate by the investigative team. This occurred after the model for an enhanced sensory environment could be documented 75% of the time on at least 3 consecutive participants.
The aim of this randomized clinical trial was to assess the effect of a sensory-based intervention in the NICU on outcomes of preterm infants and their families.
After obtaining informed consent, 70 preterm infants were randomized to 2 levels of sensory exposure: the sensory-based intervention or traditional care group. The parents of infants in the sensory-based intervention group were educated and supported to conduct sensory interventions with their infants using the systematized protocol. The traditional care group had therapists and nurses provide and educate parents about sensory exposures as standard of care. For both care groups, infant neurobehavior, sensory processing, mother-infant interaction, and parent mental health were assessed at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year corrected using standardized measures. Differences between groups were explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The control group received standard hospital care. | |
| Intervention | Experimental | Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENSE Program | Other | Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant. |
| Measure | Description | Time Frame |
|---|---|---|
| Ages and Stages Questionnaire (ASQ) - Communication at 1 Year | Parents completed the parent-report measure of child development, the Ages and Stages Questionnaire (ASQ), at 1 year corrected age. The ASQ The Communication subscore is the primary variable of interest, which looks at the child's language and communication skills at time of assessment. Higher scores on the ASQ Communication subsection indicate more positive outcomes. A child can score a minimum of 0 points and a maximum of 60 points on the Communication subscale. | One year corrected age |
| Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age | Infants were assessed using the NICU Network Neurobehavioral Scale (NNNS) by a blinded evaluator. The Excitability subscore, which measures state-related level of arousal over the course of the whole examination, is the primary variable of interest, and ranges from 1-8. An average response falls in the moderate, midpoint range (4-5), and describes an infant who could be brought to respond to stimuli in spite of a high degree of upset or excitement, but then can return to moderate state. Thus, a midpoint range score (4-5) would indicate a better outcome on the Excitability sub scale, whereas a lower (<4) or higher (>5) score would indicate a worse outcome. | At term equivalent age (35-41 weeks PMA) |
| Measure | Description | Time Frame |
|---|---|---|
| Language Environmental Acquisition Device (LENA) | Audio recordings of a single 16 hour period to capture language and sound exposure occurred at 34 weeks using the Language Environmental Acquisition Device (LENA). The LENA device is a digital language processor that captures environmental sound for up to 16 hours and quantifies: % of the recording with meaningful word exposure, % of the recording with electronic noise, % of the recording with noise, % of the recording with silence, and % of the recording with distant word exposure. |
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Inclusion Criteria:
Preterm Infants:
Parents:
-Parents (including emancipated minors age 12-17) of very preterm infants (VPT) born less than or equal to 32 weeks gestation at the St. Louis Children's Hospital in St. Louis, Missouri.
Exclusion Criteria:
Preterm Infants:
Parents:
-Parents with limited or no understanding of the English Language
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| Name | Affiliation | Role |
|---|---|---|
| Roberta G Pineda, PhD, OTR/L | Washington University School of Medicine; University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Volpe, J., Neurology of the Newborn 2008, Saunders: Philadelphia. | ||
| 4953280 | Background | Seay B, Harlow HF. Maternal separation in the rhesus monkey. J Nerv Ment Dis. 1965 Jun;140(6):434-41. doi: 10.1097/00005053-196506000-00006. No abstract available. | |
| 20121862 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | The control group received standard hospital care. |
| FG001 | Intervention | Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The control group received standard hospital care. |
| BG001 | Intervention | Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ages and Stages Questionnaire (ASQ) - Communication at 1 Year | Parents completed the parent-report measure of child development, the Ages and Stages Questionnaire (ASQ), at 1 year corrected age. The ASQ The Communication subscore is the primary variable of interest, which looks at the child's language and communication skills at time of assessment. Higher scores on the ASQ Communication subsection indicate more positive outcomes. A child can score a minimum of 0 points and a maximum of 60 points on the Communication subscale. | As noted in Participant Flow module, overall number of participants analyzed reflects participants who completed testing at 1 year follow-up (decrease in participants due to death, transfer, and loss to follow-up). | Posted | Mean | Standard Deviation | score on a scale | One year corrected age |
|
1 year, 6 months
No adverse events reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | The control group received standard hospital care. | 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberta Pineda | Washington University | 314-286-1304 | bobbi.pineda@chan.usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2021 | Apr 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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SENSE program-treatment; standard-of-care-control
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Parents were asked to participate in a study investigating 2 different approaches to sensory exposures in the NICU. The approach (SENSE or standard of care) were described after enrollment, based on which group they were randomized to. The evaluator was blinded to treatment assignment.
|
|
| Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation. |
| Sensory Exposures Provided During Hospitalization | During each day of hospitalization (from day of consent, often within 1 week of birth, to day of discharge, often near term-equivalent age; an average of about 2 months), parents, health care professionals and the sensory support team documented the type and amount of tactile and auditory exposures conducted. The proportion of the SENSE program doses, whether parents conducted the majority of the sensory exposures and whether the doses were met were defined after hospital discharge was complete. | Sensory exposures were documented every day of hospitalization (from birth to term-equivalent age; an average of about 2 months). |
| Dubowitz/Hammersmith Neonatal Neurological Evaluation | At the NICU bedside, infant neurobehavior was assessed by a blinded evaluator using the Dubowitz/Hammersmith Neonatal Neurological Evaluation (HNNE). The HNNE is an assessment of neonatal neurological status. The total score is used as an outcome variable and ranges from 0-78. A higher score indicates a better outcome, whereas a lower score indicates a worse outcome. | At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital. |
| General Movement Assessment (GMA) | A video recording was conducted to enable scoring of general movements and infant neurological/motor status using the General Movements Assessment. However, video quality was deemed insufficient for analysis. | At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital. |
| Discharge Questionnaire | Prior to discharge from the hospital, the infant's mother completed a questionnaire. Measures included the Sensory Profile-2 (SP-2), the State Trait Anxiety Inventory (STAI), the Edinburgh Postnatal Depression Scale (EPDS), the Parent Stress Index (PSI), The Parental Stress Scale: NICU (PSS), the Maternal Confidence Questionnaire, and the Infant Care Questionnaire (ICQ). The SP-2 assesses infant sensory processing skills with summary scores for tactile, auditory, visual, movement, oral, and general processing. The STAI measures maternal anxiety separated into state-related and trait-related anxiety. The PSI includes subscales to measure defensive responding, parental distress, parent-child dysfunctional interaction, & difficult child behaviors. The ICQ measures maternal connection, emotionality, and responsiveness. Possible score ranges and directions of scores listed with each variable below. | Just prior to discharge from the hospital (between 35-41 weeks post menstrual age). |
| 1 Year Follow-Up Questionnaire | The infant's mother completed a questionnaire with the following measures: the ASQ, SP-2, STAI, Beck Depression Inventory (BDI), PSI, Maternal Confidence Questionnaire (MCQ), ICQ, Pediatric Eating Assessment Tool (Pedi-eat), and Behavioral Pediatrics Feeding Assessment Scale (BPFAS). ASQ, SP-2, STAI, PSI, MCQ, and ICQ are previously described in discharge questionnaire outcome data. The BDI was used to measure maternal depression at time of follow-up. The Pedi-eat and BPFAS were used to assess infant feeding skills. Possible score ranges and directions of scores are reported below under each individual variable. | One year corrected age. |
| Mother-Infant Interaction (at 1 Year Follow-up) | At one year follow-up, mother-infant interaction will be assessed through the interaction subscale of the Parental Stress Index (PSI). A score in this subscale can range from 12-60, with higher scores indicating a greater degree of dysfunction. | One year corrected age. |
| Parent Engagement During Hospitalization | On each day of hospitalization (from birth to discharge, which often occurred close to term equivalent age; for an average of about 2 months), parents, health care professionals and the sensory support team documented the frequency of parent visitation, holding, and skin-to-skin care. | Every day of hospitalization (from birth through discharge, often close to term equivalent age; on average about 2 months). |
| Language Environmental Acquisition Device (LENA) Adult Word Count | Audio recordings of a single 16 hour period to capture language and sound exposure occurred at 34 weeks using the Language Environmental Acquisition Device (LENA). The LENA device is a digital language processor that captures environmental sound for up to 16 hours and can quantify the number of adult words spoken during the 16 hour recording. | Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation. |
| Percentage of Sensory Interventions Received | Throughout hospitalization, parents, health care professionals and the sensory support team documented the type and amount of tactile and auditory exposures conducted. The percentage of recommended sensory doses that were received were documented. | Sensory exposures were documented every day of hospitalization (birth through discharge, often close to term) equivalent age). |
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| Background | Pineda, R., Neil, J., Dierker, D., Smyser, C., Kidokora, H., Reynolds, L., Walker, S., Rogers, C., Mathur, A., VanEssen, D., Inder, T., The Impact of Different Neonatal Intensive Care Environments on Brain Development and Function in Preterm Infants, 2012, Washington University School of Medicine. |
| Background | Caskey, M., Tucker, R., Vohr. Language environment in a single familly room NICU. in Pediatric Academic Societies. 2012. Boston, MA. |
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| 20656455 | Background | Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. J Clin Epidemiol. 2010 Dec;63(12):1308-11. doi: 10.1016/j.jclinepi.2010.07.001. Epub 2010 Jul 24. No abstract available. |
| 23200264 | Background | Pineda JA, Leonard JR, Mazotas IG, Noetzel M, Limbrick DD, Keller MS, Gill J, Doctor A. Effect of implementation of a paediatric neurocritical care programme on outcomes after severe traumatic brain injury: a retrospective cohort study. Lancet Neurol. 2013 Jan;12(1):45-52. doi: 10.1016/S1474-4422(12)70269-7. Epub 2012 Nov 28. |
| 23062065 | Background | Proctor EK, Powell BJ, Baumann AA, Hamilton AM, Santens RL. Writing implementation research grant proposals: ten key ingredients. Implement Sci. 2012 Oct 12;7:96. doi: 10.1186/1748-5908-7-96. |
| 22337867 | Background | Proctor E. Implementation science and child maltreatment: methodological advances. Child Maltreat. 2012 Feb;17(1):107-12. doi: 10.1177/1077559512437034. Epub 2012 Feb 15. No abstract available. |
| 20957426 | Background | Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. |
| 19104929 | Background | Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health. 2009 Jan;36(1):24-34. doi: 10.1007/s10488-008-0197-4. Epub 2008 Dec 23. |
| 24089591 | Background | Proctor EK, Rosen A. From Knowledge Production to Implementation: Research Challenges and Imperatives. Res Soc Work Pract. 2008 Jul 1;18(4):285-291. doi: 10.1177/1049731507302263. |
| 23972955 | Background | Khlif MS, Colditz PB, Boashash B. Effective implementation of time-frequency matched filter with adapted pre and postprocessing for data-dependent detection of newborn seizures. Med Eng Phys. 2013 Dec;35(12):1762-9. doi: 10.1016/j.medengphy.2013.07.005. Epub 2013 Aug 21. |
| 23297655 | Background | Lobb R, Colditz GA. Implementation science and its application to population health. Annu Rev Public Health. 2013;34:235-51. doi: 10.1146/annurev-publhealth-031912-114444. Epub 2013 Jan 7. |
| 21765196 | Background | Wolin KY, Colditz GA, Proctor EK. Maximizing benefits for effective cancer survivorship programming: defining a dissemination and implementation plan. Oncologist. 2011;16(8):1189-96. doi: 10.1634/theoncologist.2011-0054. Epub 2011 Jul 17. |
| Background | Speilberger, C., State-Trait Anxiety Inventory for Adults. 2005-2008, Menlo Park, CA: Mind Garden. |
| 3651732 | Background | Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782. |
| Background | Endler, N., Coping Inventory for Stressful Situations (CISS): Manual. 1990, Toronto: Multi-Health Systems. |
| Background | Abidin, R.R., Parenting stress index professional manual. 3 ed. 1995, Odessa, FL: Psychological Assessment Resources, Inc. |
| 23909942 | Background | Tronick E, Lester BM. Grandchild of the NBAS: the NICU network neurobehavioral scale (NNNS): a review of the research using the NNNS. J Child Adolesc Psychiatr Nurs. 2013 Aug;26(3):193-203. doi: 10.1111/jcap.12042. |
| Background | Dunn, W., Infant/Toddler Sensory Profile 2. 2014, San Antonio: Pearson Education, Inc. |
| Background | Squires, J., et al., Ages and Stages Questionnaires - 3. 2009, Baltimore, MD: Paul H. Brookes Publishing Co. |
| Background | Beck, A.T., R.A. Steer, and G.K. Brown, Manual for the beck depression inventory-II. 1996, San Antonio, TX: Psychological Corporation. |
| 6880820 | Background | Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. |
| Background | Snaith, R.P. and A.S. Zigmond, The hospital anxiety and depression scale manual. 1994, Windsor, Ontario: NFER-Nelson. |
| 24029804 | Background | Yu YT, Hsieh WS, Hsu CH, Chen LC, Lee WT, Chiu NC, Wu YC, Jeng SF. A psychometric study of the Bayley Scales of Infant and Toddler Development - 3rd Edition for term and preterm Taiwanese infants. Res Dev Disabil. 2013 Nov;34(11):3875-83. doi: 10.1016/j.ridd.2013.07.006. Epub 2013 Sep 9. |
| 23036482 | Result | Pineda RG, Tjoeng TH, Vavasseur C, Kidokoro H, Neil JJ, Inder T. Patterns of altered neurobehavior in preterm infants within the neonatal intensive care unit. J Pediatr. 2013 Mar;162(3):470-476.e1. doi: 10.1016/j.jpeds.2012.08.011. Epub 2012 Oct 1. |
| 24656293 | Result | Howe TH, Sheu CF, Wang TN, Hsu YW. Parenting stress in families with very low birth weight preterm infants in early infancy. Res Dev Disabil. 2014 Jul;35(7):1748-56. doi: 10.1016/j.ridd.2014.02.015. Epub 2014 Mar 19. |
| 20530301 | Result | Singer LT, Fulton S, Kirchner HL, Eisengart S, Lewis B, Short E, Min MO, Satayathum S, Kercsmar C, Baley JE. Longitudinal predictors of maternal stress and coping after very low-birth-weight birth. Arch Pediatr Adolesc Med. 2010 Jun;164(6):518-24. doi: 10.1001/archpediatrics.2010.81. |
| 26058331 | Result | Wraight CL, McCoy J, Meadow W. Beyond stress: describing the experiences of families during neonatal intensive care. Acta Paediatr. 2015 Oct;104(10):1012-7. doi: 10.1111/apa.13071. Epub 2015 Jun 26. |
| 22788072 | Result | Bouet KM, Claudio N, Ramirez V, Garcia-Fragoso L. Loss of parental role as a cause of stress in the neonatal intensive care unit. Bol Asoc Med P R. 2012 Jan-Mar;104(1):8-11. |
| 23590800 | Result | Heinemann AB, Hellstrom-Westas L, Hedberg Nyqvist K. Factors affecting parents' presence with their extremely preterm infants in a neonatal intensive care room. Acta Paediatr. 2013 Jul;102(7):695-702. doi: 10.1111/apa.12267. Epub 2013 May 8. |
| 12824207 | Result | Anderson P, Doyle LW; Victorian Infant Collaborative Study Group. Neurobehavioral outcomes of school-age children born extremely low birth weight or very preterm in the 1990s. JAMA. 2003 Jun 25;289(24):3264-72. doi: 10.1001/jama.289.24.3264. |
| 18249240 | Result | Anderson PJ, Doyle LW. Cognitive and educational deficits in children born extremely preterm. Semin Perinatol. 2008 Feb;32(1):51-8. doi: 10.1053/j.semperi.2007.12.009. |
| 11889346 | Result | Holsti L, Grunau RV, Whitfield MF. Developmental coordination disorder in extremely low birth weight children at nine years. J Dev Behav Pediatr. 2002 Feb;23(1):9-15. doi: 10.1097/00004703-200202000-00002. |
| 9489494 | Result | Goyen TA, Lui K, Woods R. Visual-motor, visual-perceptual, and fine motor outcomes in very-low-birthweight children at 5 years. Dev Med Child Neurol. 1998 Feb;40(2):76-81. doi: 10.1111/j.1469-8749.1998.tb15365.x. |
| 24139564 | Result | Pineda RG, Neil J, Dierker D, Smyser CD, Wallendorf M, Kidokoro H, Reynolds LC, Walker S, Rogers C, Mathur AM, Van Essen DC, Inder T. Alterations in brain structure and neurodevelopmental outcome in preterm infants hospitalized in different neonatal intensive care unit environments. J Pediatr. 2014 Jan;164(1):52-60.e2. doi: 10.1016/j.jpeds.2013.08.047. Epub 2013 Oct 17. |
| 18209730 | Result | Bystron I, Blakemore C, Rakic P. Development of the human cerebral cortex: Boulder Committee revisited. Nat Rev Neurosci. 2008 Feb;9(2):110-22. doi: 10.1038/nrn2252. |
| 18595988 | Result | Burns CM, Rutherford MA, Boardman JP, Cowan FM. Patterns of cerebral injury and neurodevelopmental outcomes after symptomatic neonatal hypoglycemia. Pediatrics. 2008 Jul;122(1):65-74. doi: 10.1542/peds.2007-2822. |
| 21951265 | Result | Berument SK, Sonmez D, Eyupoglu H. Supporting language and cognitive development of infants and young children living in children's homes in Turkey. Child Care Health Dev. 2012 Sep;38(5):743-52. doi: 10.1111/j.1365-2214.2011.01314.x. Epub 2011 Sep 27. |
| 17685176 | Result | Daunhauer LA, Coster WJ, Tickle-Degnen L, Cermak SA. Effects of caregiver-child interactions on play occupations among young children institutionalized in Eastern Europe. Am J Occup Ther. 2007 Jul-Aug;61(4):429-40. doi: 10.5014/ajot.61.4.429. |
| 20367513 | Result | Daunhauer LA, Coster WJ, Tickle-Degnen L, Cermak SA. Play and cognition among young children reared in an institution. Phys Occup Ther Pediatr. 2010 May;30(2):83-97. doi: 10.3109/01942630903543682. |
| 15381896 | Result | Ellis BH, Fisher PA, Zaharie S. Predictors of disruptive behavior, developmental delays, anxiety, and affective symptomatology among institutionally reared romanian children. J Am Acad Child Adolesc Psychiatry. 2004 Oct;43(10):1283-92. doi: 10.1097/01.chi.0000136562.24085.160. |
| Withdrawal by Subject |
|
| Transfer to another hospital |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | EGA at birth (weeks) |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Intervention | Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant. |
|
|
| Primary | Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age | Infants were assessed using the NICU Network Neurobehavioral Scale (NNNS) by a blinded evaluator. The Excitability subscore, which measures state-related level of arousal over the course of the whole examination, is the primary variable of interest, and ranges from 1-8. An average response falls in the moderate, midpoint range (4-5), and describes an infant who could be brought to respond to stimuli in spite of a high degree of upset or excitement, but then can return to moderate state. Thus, a midpoint range score (4-5) would indicate a better outcome on the Excitability sub scale, whereas a lower (<4) or higher (>5) score would indicate a worse outcome. | Overall number of participants analyzed reflects number of participants assessed at term equivalent age (some were lost at this time point for this assessment due to death or transfer to a different hospital). | Posted | Mean | Standard Deviation | score on a scale | At term equivalent age (35-41 weeks PMA) |
|
|
|
| Secondary | Language Environmental Acquisition Device (LENA) | Audio recordings of a single 16 hour period to capture language and sound exposure occurred at 34 weeks using the Language Environmental Acquisition Device (LENA). The LENA device is a digital language processor that captures environmental sound for up to 16 hours and quantifies: % of the recording with meaningful word exposure, % of the recording with electronic noise, % of the recording with noise, % of the recording with silence, and % of the recording with distant word exposure. | Overall number of participants analyzed reflects number of participants assessed at 34 weeks (some were lost at this time point for this assessment due to death or transfer to a different hospital or inability to complete recording due to technological or administrative issues). | Posted | Mean | Standard Deviation | percentage of 16h recording | Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation. |
|
|
|
| Secondary | Sensory Exposures Provided During Hospitalization | During each day of hospitalization (from day of consent, often within 1 week of birth, to day of discharge, often near term-equivalent age; an average of about 2 months), parents, health care professionals and the sensory support team documented the type and amount of tactile and auditory exposures conducted. The proportion of the SENSE program doses, whether parents conducted the majority of the sensory exposures and whether the doses were met were defined after hospital discharge was complete. | Posted | Count of Participants | Participants | Sensory exposures were documented every day of hospitalization (from birth to term-equivalent age; an average of about 2 months). |
|
|
|
| Secondary | Dubowitz/Hammersmith Neonatal Neurological Evaluation | At the NICU bedside, infant neurobehavior was assessed by a blinded evaluator using the Dubowitz/Hammersmith Neonatal Neurological Evaluation (HNNE). The HNNE is an assessment of neonatal neurological status. The total score is used as an outcome variable and ranges from 0-78. A higher score indicates a better outcome, whereas a lower score indicates a worse outcome. | The number of participants analyzed reflects the number of infants who underwent HNNE assessment at 35-41 weeks post menstrual age; some infants were not assessed at this time point due to death or transfer to a different hospital prior to NICU discharge. | Posted | Mean | Standard Deviation | score on a scale | At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital. |
|
|
|
| Secondary | General Movement Assessment (GMA) | A video recording was conducted to enable scoring of general movements and infant neurological/motor status using the General Movements Assessment. However, video quality was deemed insufficient for analysis. | Video quality was insufficient for appropriate scoring and thus not analyzed. | Posted | At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital. |
|
|
| Secondary | Discharge Questionnaire | Prior to discharge from the hospital, the infant's mother completed a questionnaire. Measures included the Sensory Profile-2 (SP-2), the State Trait Anxiety Inventory (STAI), the Edinburgh Postnatal Depression Scale (EPDS), the Parent Stress Index (PSI), The Parental Stress Scale: NICU (PSS), the Maternal Confidence Questionnaire, and the Infant Care Questionnaire (ICQ). The SP-2 assesses infant sensory processing skills with summary scores for tactile, auditory, visual, movement, oral, and general processing. The STAI measures maternal anxiety separated into state-related and trait-related anxiety. The PSI includes subscales to measure defensive responding, parental distress, parent-child dysfunctional interaction, & difficult child behaviors. The ICQ measures maternal connection, emotionality, and responsiveness. Possible score ranges and directions of scores listed with each variable below. | Questionnaires were included if complete; number of participants analyzed reflects number of completed questionnaires. Reasons for questionnaire incompletion were: infant death, transfer prior to discharge. | Posted | Mean | Standard Deviation | score on a scale | Just prior to discharge from the hospital (between 35-41 weeks post menstrual age). |
|
|
|
| Secondary | 1 Year Follow-Up Questionnaire | The infant's mother completed a questionnaire with the following measures: the ASQ, SP-2, STAI, Beck Depression Inventory (BDI), PSI, Maternal Confidence Questionnaire (MCQ), ICQ, Pediatric Eating Assessment Tool (Pedi-eat), and Behavioral Pediatrics Feeding Assessment Scale (BPFAS). ASQ, SP-2, STAI, PSI, MCQ, and ICQ are previously described in discharge questionnaire outcome data. The BDI was used to measure maternal depression at time of follow-up. The Pedi-eat and BPFAS were used to assess infant feeding skills. Possible score ranges and directions of scores are reported below under each individual variable. | Number of participants analyzed reflects the number of received follow-up questionnaires at 1 year corrected age. Participants who died, transferred to a different NICU prior to discharge, or did not complete follow-up questionnaires were not included. | Posted | Mean | Standard Deviation | score on a scale | One year corrected age. |
|
|
|
| Secondary | Mother-Infant Interaction (at 1 Year Follow-up) | At one year follow-up, mother-infant interaction will be assessed through the interaction subscale of the Parental Stress Index (PSI). A score in this subscale can range from 12-60, with higher scores indicating a greater degree of dysfunction. | Overall number of participants analyzed reflects the number of participants who returned completed questionnaires at 1 year corrected age. Reasons for lack of completion included: death of infant, transfer to different hospital prior to NICU discharge, lost to follow-up (not responding to calls/mail). | Posted | Mean | Standard Deviation | score on a scale | One year corrected age. |
|
|
|
| Secondary | Parent Engagement During Hospitalization | On each day of hospitalization (from birth to discharge, which often occurred close to term equivalent age; for an average of about 2 months), parents, health care professionals and the sensory support team documented the frequency of parent visitation, holding, and skin-to-skin care. | Overall number of participants analyzed reflects total number of participants with complete bedside logs at time of NICU discharge. Some participants were lost due to death or hospital transfer prior to discharge. | Posted | Mean | Standard Deviation | Days | Every day of hospitalization (from birth through discharge, often close to term equivalent age; on average about 2 months). |
|
|
|
| Secondary | Language Environmental Acquisition Device (LENA) Adult Word Count | Audio recordings of a single 16 hour period to capture language and sound exposure occurred at 34 weeks using the Language Environmental Acquisition Device (LENA). The LENA device is a digital language processor that captures environmental sound for up to 16 hours and can quantify the number of adult words spoken during the 16 hour recording. | Overall number of participants analyzed reflects number of participants assessed at 34 weeks (some were lost at this time point for this assessment due to death or transfer to a different hospital or inability to complete recording due to technological or administrative issues). | Posted | Mean | Standard Deviation | words | Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation. |
|
|
|
| Secondary | Percentage of Sensory Interventions Received | Throughout hospitalization, parents, health care professionals and the sensory support team documented the type and amount of tactile and auditory exposures conducted. The percentage of recommended sensory doses that were received were documented. | Overall number of participants analyzed reflects total number of participants with complete bedside logs at time of NICU discharge. Some participants were lost due to death or hospital transfer prior to discharge. | Posted | Mean | Standard Deviation | percentage of interventions received | Sensory exposures were documented every day of hospitalization (birth through discharge, often close to term) equivalent age). |
|
|
|
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Intervention | Parents in the sensory-based intervention group were educated to provide daily sensory-based interventions across the length of hospitalization as outlined in the manualized intervention (the SENSE Program). A sensory support team completed the doses of sensory exposures when parents were unable. SENSE Program: Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant. | 1 | 31 | 0 | 31 | 0 | 31 |
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| % TV or electronic sounds |
|
| % Noise |
|
| % Silence |
|
| Parent provided > 50% of interventions received |
|
| Sensory Profile - Visual (range 4-20)higher = possible dysfunction |
|
| Sensory Profile - Movement (range 4-20) higher = possible dysfunction |
|
| Sensory Profile - Oral (range 2-10) higher = possible dysfunction |
|
| Sensory Profile - General (range 8-40) higher = possible dysfunction |
|
| PSI- Defensive Responding (range 7-35) Higher = more dysfunction |
|
| PSI - Parental Distress (range 12-60) Higher = more dysfunction |
|
| PSI - Parent-Child Dysfunctional Interaction (range 12-60) Higher = more dysfunction |
|
| PSI - Difficult Child (range 12-60) Higher = more dysfunction |
|
| Edinburgh Postnatal Depression Scale (range 0-30) Higher = more likelihood of depression |
|
| Parental Stressor Scale - NICU (range 0-5), Higher = more stress |
|
| STAI - State Anxiety (range 20-80) Higher = more anxiety |
|
| STAI - Trait Anxiety (range 20-80) Higher = more anxiety |
|
| Maternal Confidence Questionnaire (range 0-56) Higher = more stress |
|
| ICQ - Mom and Baby (range 0-5), Higher = better care |
|
| ICQ - Emotionality (range 0-5), Higher = better care |
|
| ICQ - Responsiveness (range 0-5), Higher = better care |
|
| PSI - Difficult Child (range 12-60), higher = more dysfunction |
|
| Beck Depression Inventory (range 0-63), Higher = more depression |
|
| STAI - State Anxiety (range 20-80), Higher = more anxiety |
|
| STAI - Trait Anxiety (range 20-80), Higher = more anxiety |
|
| Maternal Confidence Questionnaire (range 0-56), Higher = more confidence |
|
| ICQ - Mom and Baby (range 0-5), higher = better care |
|
| ICQ - Emotionality (range 0-5), higher = better care |
|
| ICQ - Responsiveness (range 0-5), higher = better care |
|
| ASQ - Communication (range 0-60), Higher = better |
|
| ASQ - Problem Solving (range 0-60), Higher = better |
|
| ASQ - Gross Motor (range 0-60), Higher = better |
|
| ASQ - Fine Motor (range 0-60), higher = better |
|
| ASQ - Personal-Social (range 0-60), higher = better |
|
| Sensory Profile - Touch (range 10-50), higher = more dysfunction |
|
| Sensory Profile - Auditory (range 7-35), Higher = more dysfunction |
|
| Sensory Profile - Visual (range 8-40), Higher = more dysfunction |
|
| Sensory Profile - Movement Processing (range 6-30), Higher = more dysfunction |
|
| Sensory Profile - Oral (range 7-35), higher = more dysfunction |
|
| Sensory Profile - General (range 10-50), Higher = more dysfunction |
|
| Sensory Profile - Behavior (range 6-30), Higher = more dysfunction |
|
| Pediatric Eating Assessment Tool (range 0-390), Higher = more dysfunction |
|
| Behavioral Pediatrics Feeding Assessment Scale (range 0-175), Higher = more dysfunction |
|
| Average number of days per 5-day week parents provided skin-to-skin care |
|