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The purpose of the study is to learn more about the development of small for gestational age (SGA) preterm infants and whether focusing on the infant's behavior has a positive effect on outcome. The study hypotheses state: 1) High risk severely SGA preterm infants will profit from detailed neuropsychological assessment, psychoeducational recommendations and practical guidance for caregiving, as well as formal educational and emotional support for the family and the professional care team. 2) Neuropsychological education and guidance for community-based early intervention providers caring for SGA preterm infants after their discharge is effective in promoting improved outcome.
The preterm infant who is not only born early but also did not grow well in the womb is at double jeopardy for developmental disabilities. The literature indicates that the fetus who has not gained weight properly nor is showing expected head growth in the womb [symmetrical intrauterine growth retardation (IUGR) or small for gestational age (SGA) status] will not only require significantly longer stays in the newborn intensive care unit (NICU) and grow more poorly than the appropriately grown prematurely born infant, but will also show significant disabilities later on in terms of fine and gross motor skills, cognitive function activity, language abilities, abstract reasoning, concentration, attention, mood and temperament. IUGR exerts an independent adverse effect on the developmental outcome of preterm infants.
Given the importance of the last 4 months of gestation and the first 2 years post term for brain growth and development, and given the relationship between cerebral development and behavior which is a two-way street and a dynamic feedback system, the particular vulnerability of SGA children to environmental factors indicates that there are grounds for the hypothesis that appropriate support and intervention for severely SGA preterm infants and their families might ameliorate dysfunction.
The general purpose of the proposed project is to develop and test a model of ameliorative neuropsychoeducational intervention in the NICU in support of the developmental outcome of severely SGA preterm infants and their families. The specific hypotheses to be tested are as follows:
High risk severely SGA preterm infants cared for in the NICU with the support of a neuropsychoeducational model of intervention will show:
At 2 weeks post term, more well-regulated autonomic, motor, state organizational and attentional functioning
At 9 and 24 months post term:
Parents whose infants receive the support of a neuropsychoeducational model of care will show:
The population will consist of severely small for gestational age preterm infants admitted to the NICU and randomly assigned to a control and experimental group.
Effectiveness of the experimental treatment for the experimental group will be tested at three systematic outcome points in various domains. The domains assessed include (1) medical outcome; (2) neurobehavioral outcome; (3) neuroelectrophysiological outcome; and (4) family outcome. The outcome points for infant and family are 2 weeks, 9 and 24 months after expected due date.
The study is expected to demonstrate intervention effectiveness in improving IUGR preterm infants' neurodevelopment. It is anticipated that the results will set the stage for a model of caregiving and intervention that lives up to the mandate that every child is entitled to an environment, care and education appropriate to his or her specific needs. The model can then be used in other nurseries to provide improved outcome for preterm populations.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Newborn Individualized Developmental Care | Behavioral | The developmental care model aims to create a relationship-based developmentally supportive care environment for the preterm infant and family. The theory proposes that care implementation that takes into account infants' thresholds of disorganization is most supportive of long term outcome. Specifically, the intervention consisted of weekly neurobehavioral observations and reports of the experimental group infants' behavior with suggestions for parents and staff in ways to support each infant's development. The developmental specialists observed each infant's behavior throughout hospitalization and to 2 weeks corrected age and formulated descriptive neurobehavioral reports with suggestions to structure caregiving procedures adapted to the infant's sleep/wake cycle and in support of the infant's well-regulated behavioral balance. Parents were supported to care for their infant, encouraged to nurse and hold their infant skin-to-skin, and to cradle them during stressful procedures. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evidence of improved neurodevelopmental and neurophysiological outcome as assessed with: Assessment of Preterm Infants' Behavior (APIB) and electrophysiological (EEG) assessment | At 2 weeks , 9 months and 24 months corrected age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidelise Als, PhD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Children's Hospital Boston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23421857 | Derived | McAnulty G, Duffy FH, Kosta S, Weisenfeld NI, Warfield SK, Butler SC, Alidoost M, Bernstein JH, Robertson R, Zurakowski D, Als H. School-age effects of the newborn individualized developmental care and assessment program for preterm infants with intrauterine growth restriction: preliminary findings. BMC Pediatr. 2013 Feb 19;13:25. doi: 10.1186/1471-2431-13-25. | |
| 22301525 |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Boston |
| Massachusetts |
| 02115 |
| United States |
| Als H, Duffy FH, McAnulty G, Butler SC, Lightbody L, Kosta S, Weisenfeld NI, Robertson R, Parad RB, Ringer SA, Blickman JG, Zurakowski D, Warfield SK. NIDCAP improves brain function and structure in preterm infants with severe intrauterine growth restriction. J Perinatol. 2012 Oct;32(10):797-803. doi: 10.1038/jp.2011.201. Epub 2012 Feb 2. |
| 20651694 | Derived | Als H, Duffy FH, McAnulty GB, Fischer CB, Kosta S, Butler SC, Parad RB, Blickman JG, Zurakowski D, Ringer SA. Is the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) effective for preterm infants with intrauterine growth restriction? J Perinatol. 2011 Feb;31(2):130-6. doi: 10.1038/jp.2010.81. Epub 2010 Jul 22. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |