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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002490 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The Therapist Education and Massage for Parent-Infant Outcomes program is evidence-based and includes infant massage, physical therapy interventions including developmental support and play activities to promote infant behavioral-motor development, principles of family-centered care, and multiple modes of educational delivery to enhance parent retention of knowledge, parent-infant bonding, and confidence in continuing physical therapy interventions after discharge.
The Therapist Education and Massage for Parent-Infant Outcomes program involves components during and after hospitalization.
During infant hospitalization • Visit 1: Early Parent Education Session: Initiated within 3 weeks of infant birth. The therapist will educate the parent about the importance of infant positioning, the impact of prematurity on the motor and sensory systems, and how to read and respond to infant behavioral-motor cues using a written pamphlet with pictures to supplement the verbal education lasting about 30 minutes.
The therapist will ask the parent to complete a contact information form and a demographic form and a baseline questionnaire.
Pre and Post both massage sessions, the Primary Investigator or study coordinator will collect salivary cortisol via buccal swab as a measure of physiologic stress.
At this visit, the therapist will have the parent fill out a questionnaire.
Follow- up procedures (by visits) The program has additional components that extend beyond the hospital period. Parent and infant outcome measures will be collected at the first follow-up and 12 month corrected age follow-up clinic visits.
After hospitalization:
Visit 1: Parent Education Post-Discharge: The therapist will call the parent within 2 weeks of discharge to follow up about discharge education and massage. During this phone call, the therapist will review the home program and massage techniques. The therapist will also answer any parent questions. Therapist email and pager information will be provided.
Visits 2-12 (approximate): Bi-weekly emails (or texts): The therapist will send bi-weekly emails or texts (depending on parents' preference) with developmental play activity and massage reminders and tips from hospital discharge through the first follow up appointment.
Visit 13 (approximate): First Visit Follow-up Massage Review Session: At the infant's first follow-up appointment with the multidisciplinary neonatology team, the therapist will provide a gross motor screening assessment and education. In addition, as part of the program, a therapist will facilitate a parent-administered infant massage session to provide an opportunity for parent to receive feedback on technique from the therapist. This session will address any safety concerns, infant changes, and parent questions.
o At this visit, the therapist will have the parent fill out a questionnaire for ongoing measurement.
Visits 14+ (approximate): Bi-weekly emails (or texts): The therapist will continue to send bi-weekly emails or texts (depending on parents' preference) with developmental play activity and massage reminders until the 12 month followup appointment.
12 Month Follow-up Appointment: At the standard of care 12 month corrected age follow-up appointment with the multidisciplinary neonatology team, the PI or study coordinator will interview the parent about acceptability of the program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEMPO | Experimental | The Therapist Education and Massage for Parent-Infant Outcomes program (TEMPO) is a structured, therapist-led physical therapy program. TEMPO trains and supports parents to deliver physical therapy interventions including massage and developmental play during hospitalization and in the home setting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapist Education and Massage for Parents of Extremely Preterm Infants | Other | TEMPO includes these components:
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment) | Recruitment is defined as the percent of eligible participants enrolled of those approached. | Baseline |
| Percent of Parents Who Would Recommend This Program to Other Parents of Preterm Infants | The percent of enrolled parents who report they would recommend the program to other parents. | Final follow up visit - an average of 15-18 months after study period begins |
| Percent of Parents Who Complete All Protocol Components (Adherence) | The percent of enrolled parents who complete all protocol components during hospitalization. | At hospital discharge, approximately 8-16 weeks after enrollment |
| Percent of Parents Who Are Retained in the Study at 12 Months (Retention) | Percent of enrolled parents who are retained in the study at 12 months. | Final follow up visit - an average of 15-18 months after study period begins |
| Percent of Enrolled Parents Who Provide Complete Data and Interviews | The percent of enrolled parents who provide complete data and interviews. | Final follow up visit - an average of 15-18 months after study period begins |
| Average Number of Days Per Week That Enrolled Parents Complete TEMPO Activities | The average days per week that parents completed TEMPO activities based on parents' weekly self reports. | at First follow up visit - approximately 1 to 2 months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Infant Salivary Cortisol Level | Buccal swab will be taken immediately pre and post massage implementation during hospitalization at the massage education session with therapist. Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. Salivary cortisol is a biomarker for stress15 that may be used to understand the mechanism by which the intervention impacts physiological stress states. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana McCarty, DPT | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Children's Hospital | Chapel Hill | North Carolina | 27759 | United States |
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| Label | URL |
|---|---|
| NIH Data Sharing Policy | View source |
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the university.
NIH expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. Publication is anticipated within one year of the study conclusion.
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| ID | Title | Description |
|---|---|---|
| FG000 | TEMPO | The Therapist Education and Massage for Parent-Infant Outcomes program (TEMPO) is a structured, therapist-led physical therapy program. TEMPO trains and supports parents to deliver physical therapy interventions including massage and developmental play during hospitalization and in the home setting. Therapist Education and Massage for Parents of Extremely Preterm Infants: TEMPO includes these components:
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TEMPO Parents | The Therapist Education and Massage for Parent-Infant Outcomes program (TEMPO) is a structured, therapist-led physical therapy program. TEMPO trains and supports parents to deliver physical therapy interventions including massage and developmental play during hospitalization and in the home setting. Therapist Education and Massage for Parents of Extremely Preterm Infants: TEMPO includes these components:
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| Units | Counts |
|---|---|
| Participants |
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| 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 | Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment) | Recruitment is defined as the percent of eligible participants enrolled of those approached. | Posted | Number | percentage of participants | Baseline |
|
Adverse events were collected for infants only from the time of parental informed consent through hospital discharge, approximately 8-16 weeks after enrollment. Since infants were the only population considered to be as risk, adverse events were not collected for parents.
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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 | TEMPO Infants | PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) PT and OT Intervention at <33 weeks PMA: During hospitalization, infants received PT and OT intervention 4-5 times weekly (total) for approximately 15-30 minutes at a time. PT and OT Re-assessment: Performed between 33-34 weeks PMA if infant was physiologically stable. PT and OT Intervention >33 weeks PMA: Infants continued to receive combined PT or OT intervention 4-5 times weekly for approximately 30 minutes. Discharge Education: In standard of care therapy, the PT or OT reviewed a 2-page handout with the parent if they are available at the bedside the week of discharge. <4 month and 12-month Follow-Up Visits: The Special Infant Care Clinic is a multidisciplinary follow-up clinic that follows the neurodevelopment of preterm infants discharged from the NCCC. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana McCarty, PT, DPT | University of North Carolina at Chapel Hill | 919-843-8792 | dana_mccarty@med.unc.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 | Oct 17, 2019 | Feb 2, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 19, 2020 | Feb 2, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Prospective single group
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|
| Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure | Longitudinal measures of parents' perceived acceptability of intervention throughout the study period measured by the percent of parents who rate acceptability as 4/5 or 5/5 using the Acceptability of Intervention Measure. The Acceptability of Intervention Measure is a 12 item implementation outcome assessment designed to measure if the intervention is perceived as agreeable, palatable, or satisfactory. Cut-off scores for interpretation are not yet available; however, higher scores indicate greater acceptability. | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) |
| Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure | Longitudinal measures of parents' perceived feasibility of intervention throughout the study period measured by the percent of parents who rate feasibility as 4/5 or 5/5 using the Feasibility of Intervention Measure. The Feasibility of Intervention Measure is a 9 item implementation outcome assessment designed to measure the extent to which a new treatment can be successfully used or carried out. Cut-off scores for interpretation are not yet available; however, higher scores indicate greater feasibility. | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) |
| Qualitative Summaries of Parent Experience Via Interview | The Primary Investigator or research coordinator will conduct interviews with parents at both follow up visits using 3 questions developed by the Primary Investigator to assess feasibility, acceptability, and perceived benefit of massage. Yes/No responses were provided for the following questions: (1) "Was it difficult to meet the therapist weekly for TEMPO sessions?"; (2) "Would you recommend TEMPO to other parents of preterm infants?"; and (3) "Have you continued doing massage with your baby at home?". | First follow up visit - an average of 6-10 months after study period begins; Final follow up visit - an average of 15-18 months after study period begins |
| To be measured twice immediately pre-and post initial massage education in the hospital. |
| Parent Salivary Cortisol Level | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. Salivary cortisol is a biomarker for stress 15 that may be used to understand the mechanism by which the intervention impacts physiological stress states. Paired t-tests were conducted to assess pre- to post-infant massage cortisol levels in parents. | To be measured twice immediately pre-and post initial massage education in the hospital. Buccal swab will be taken immediately pre and post massage implementation during hospitalization at the massage education session with therapist. |
| Bayley Scales of Infant Development IV | The Bayley Scales of Infant Development IV (BSID-IV) is a standardized assessment to evaluate cognitive development, expressive and receptive language, and fine and gross motor development in children between the ages of 1 and 42 months. For the purpose of this study, only the gross motor scale was recorded. For infants at approximately 12 months corrected, the total gross motor scaled scores range from 0-19 with 0 indicating the highest risk of developmental delay and 19 indicating the lowest risk of developmental delay. | Final follow up visit - an average of 15-18 months after study period begins |
| Longitudinal Measures in Patient-Reported Outcomes Measurement Information System Adult Profile Short Form - Anxiety | Sample medians and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. An 8 item validated measure with each item rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety. | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) |
| Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A valid, reliable self-assessment tool for evaluating depressive symptoms in adult populations, including among mothers during and after parturition. The 20 item form will be used. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) |
| Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A 10-item self-report questionnaire validated to detect change in depressive symptoms in mothers both during and after the postnatal period. Scores range from 0-30, with scores greater than 13 indicating likely depressive illness. | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) |
| Longitudinal Measures Changes in Parenting Sense of Competence Scale | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A 17-item scale using ratings (Strongly Disagree-1, Somewhat Disagree-2, Disagree-3, Agree-4, Somewhat Agree-5, Strongly Agree-6) to assess satisfaction of parenting and parental self-efficacy in a variety of populations with a range in score from 17 to 102 and higher scores indicating a greater sense of parental self-efficacy. | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) |
| Postnatal Attachment Questionnaire | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A Maternal Postnatal Attachment Scale (MPAS) with 19 items representing 4 components: pleasure in proximity, tolerance, need-gratification and protection, and knowledge acquisition was used to query the parents' feelings about their infants under 1 year of age. The MPAS is a self-reported scale to reflect the degree of subjective emotional connection between mothers and their infants.The scale includes two, three, four and five options.The total score span of the scale is between 19-95, and the higher the score, the higher the level of maternal and child attachment. | Final follow up visit - an average of 15-18 months after study period begins |
| Longitudinal Measures in Infant Temperament Using Carey Temperament Scales | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. This questionnaire assesses nine temperamental characteristics of infants. Caregivers are presented with a statement describing a certain behavior and asked to rate how often their child behaves in that way on a scale from 1 (almost never) to 6 (almost always), with higher scores indicating more difficult temperament | First follow up visit - an average of 6-10 months after study period begins; Final follow up visit - an average of 15-18 months after study period begins |
| BG001 | TEMPO Infants | Physical Therapy (PT) and Occupational Therapy (OT) Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable)
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Percent of Parents Who Would Recommend This Program to Other Parents of Preterm Infants | The percent of enrolled parents who report they would recommend the program to other parents. | Includes all parents who were retained through the final Follow Up visit. | Posted | Number | percentage of participants | Final follow up visit - an average of 15-18 months after study period begins |
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| Primary | Percent of Parents Who Complete All Protocol Components (Adherence) | The percent of enrolled parents who complete all protocol components during hospitalization. | Six parents transferred to an outside hospital and 3 infants died prior to hospital discharge; therefore, 23 dyads were maintained at hospital discharge. | Posted | Number | percentage of participants | At hospital discharge, approximately 8-16 weeks after enrollment |
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| Primary | Percent of Parents Who Are Retained in the Study at 12 Months (Retention) | Percent of enrolled parents who are retained in the study at 12 months. | More parents agreed to a phone interview than those who agreed to return their child for testing. | Posted | Number | percentage of participants | Final follow up visit - an average of 15-18 months after study period begins |
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| Primary | Percent of Enrolled Parents Who Provide Complete Data and Interviews | The percent of enrolled parents who provide complete data and interviews. | Posted | Number | percentage of participants | Final follow up visit - an average of 15-18 months after study period begins |
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| Primary | Average Number of Days Per Week That Enrolled Parents Complete TEMPO Activities | The average days per week that parents completed TEMPO activities based on parents' weekly self reports. | Includes number of parents interviewed at first Follow up visit. | Posted | Mean | Standard Deviation | days per week | at First follow up visit - approximately 1 to 2 months after hospital discharge |
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| Primary | Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure | Longitudinal measures of parents' perceived acceptability of intervention throughout the study period measured by the percent of parents who rate acceptability as 4/5 or 5/5 using the Acceptability of Intervention Measure. The Acceptability of Intervention Measure is a 12 item implementation outcome assessment designed to measure if the intervention is perceived as agreeable, palatable, or satisfactory. Cut-off scores for interpretation are not yet available; however, higher scores indicate greater acceptability. | Data reported for all parents who responded to surveys at the specified time points. | Posted | Number | percentage of participants | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) |
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| Primary | Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure | Longitudinal measures of parents' perceived feasibility of intervention throughout the study period measured by the percent of parents who rate feasibility as 4/5 or 5/5 using the Feasibility of Intervention Measure. The Feasibility of Intervention Measure is a 9 item implementation outcome assessment designed to measure the extent to which a new treatment can be successfully used or carried out. Cut-off scores for interpretation are not yet available; however, higher scores indicate greater feasibility. | Data reported for all parents who responded to surveys at the specified time points. | Posted | Number | percentage of participants | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) |
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| Primary | Qualitative Summaries of Parent Experience Via Interview | The Primary Investigator or research coordinator will conduct interviews with parents at both follow up visits using 3 questions developed by the Primary Investigator to assess feasibility, acceptability, and perceived benefit of massage. Yes/No responses were provided for the following questions: (1) "Was it difficult to meet the therapist weekly for TEMPO sessions?"; (2) "Would you recommend TEMPO to other parents of preterm infants?"; and (3) "Have you continued doing massage with your baby at home?". | Responses reported for participants who answered "yes". | Posted | Number | percentage of participants | First follow up visit - an average of 6-10 months after study period begins; Final follow up visit - an average of 15-18 months after study period begins |
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| Secondary | Mean Infant Salivary Cortisol Level | Buccal swab will be taken immediately pre and post massage implementation during hospitalization at the massage education session with therapist. Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. Salivary cortisol is a biomarker for stress15 that may be used to understand the mechanism by which the intervention impacts physiological stress states. | Both a pre- and post initial massage sample was required to detect & report change and no sufficient samples were collected for any infant at both timepoints. Insufficient (or immeasurable) samples were collected for all infants across all timepoints. | Posted | To be measured twice immediately pre-and post initial massage education in the hospital. |
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| Secondary | Parent Salivary Cortisol Level | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. Salivary cortisol is a biomarker for stress 15 that may be used to understand the mechanism by which the intervention impacts physiological stress states. Paired t-tests were conducted to assess pre- to post-infant massage cortisol levels in parents. | Six parents transferred to an outside hospital and 3 infants died prior to hospital discharge; therefore, 23 dyads were maintained at hospital discharge. One additional male parent was excluded from analysis because salivary cortisol is sex-specific. | Posted | Mean | Standard Deviation | ng/dL | To be measured twice immediately pre-and post initial massage education in the hospital. Buccal swab will be taken immediately pre and post massage implementation during hospitalization at the massage education session with therapist. |
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| Secondary | Bayley Scales of Infant Development IV | The Bayley Scales of Infant Development IV (BSID-IV) is a standardized assessment to evaluate cognitive development, expressive and receptive language, and fine and gross motor development in children between the ages of 1 and 42 months. For the purpose of this study, only the gross motor scale was recorded. For infants at approximately 12 months corrected, the total gross motor scaled scores range from 0-19 with 0 indicating the highest risk of developmental delay and 19 indicating the lowest risk of developmental delay. | Posted | Mean | Full Range | score on a scale | Final follow up visit - an average of 15-18 months after study period begins |
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| Secondary | Longitudinal Measures in Patient-Reported Outcomes Measurement Information System Adult Profile Short Form - Anxiety | Sample medians and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. An 8 item validated measure with each item rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety. | Although 32 parents were enrolled, Baseline survey data was only collected for 24 . Hospital discharge data was collected for 19 parents. All data were reported for parents who were not lost to follow up. | Posted | Median | Standard Deviation | score on a scale | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) |
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| Secondary | Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A valid, reliable self-assessment tool for evaluating depressive symptoms in adult populations, including among mothers during and after parturition. The 20 item form will be used. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. | Although 32 parents were enrolled, Baseline survey data was only collected for 24 . Hospital discharge data was collected for 19 parents. All data were reported for parents who were not lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) |
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| Secondary | Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A 10-item self-report questionnaire validated to detect change in depressive symptoms in mothers both during and after the postnatal period. Scores range from 0-30, with scores greater than 13 indicating likely depressive illness. | Although 32 parents were enrolled, Baseline survey data was only collected for 24 . Hospital discharge data was collected for 19 parents. All data were reported for parents who were not lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) |
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| Secondary | Longitudinal Measures Changes in Parenting Sense of Competence Scale | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A 17-item scale using ratings (Strongly Disagree-1, Somewhat Disagree-2, Disagree-3, Agree-4, Somewhat Agree-5, Strongly Agree-6) to assess satisfaction of parenting and parental self-efficacy in a variety of populations with a range in score from 17 to 102 and higher scores indicating a greater sense of parental self-efficacy. | Although 32 parents were enrolled, Baseline survey data was only collected for 24 . Hospital discharge data was collected for 19 parents. All data were reported for parents who were not lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) |
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| Secondary | Postnatal Attachment Questionnaire | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A Maternal Postnatal Attachment Scale (MPAS) with 19 items representing 4 components: pleasure in proximity, tolerance, need-gratification and protection, and knowledge acquisition was used to query the parents' feelings about their infants under 1 year of age. The MPAS is a self-reported scale to reflect the degree of subjective emotional connection between mothers and their infants.The scale includes two, three, four and five options.The total score span of the scale is between 19-95, and the higher the score, the higher the level of maternal and child attachment. | All data were reported for parents who were not lost to follow up. | Posted | Mean | Standard Deviation | score on a scale | Final follow up visit - an average of 15-18 months after study period begins |
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| Secondary | Longitudinal Measures in Infant Temperament Using Carey Temperament Scales | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. This questionnaire assesses nine temperamental characteristics of infants. Caregivers are presented with a statement describing a certain behavior and asked to rate how often their child behaves in that way on a scale from 1 (almost never) to 6 (almost always), with higher scores indicating more difficult temperament | In order to limit parent burden, the investigators removed this questionnaire from the survey battery. | Posted | First follow up visit - an average of 6-10 months after study period begins; Final follow up visit - an average of 15-18 months after study period begins |
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| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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