- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00914108
Severe Intrauterine Growth Retardation: Developmental Newborn Intensive Care Unit (NICU) Care
Family-Centered Neuropsychoeducational In-NICU Intervention for Preterm Infants With Severe Intrauterine Growth Retardation and for Their Families
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- More well-regulated autonomic and visceral functioning with less colic and improved eating patterns and weight gain
- More well-regulated motor system performance
- More well-regulated state organization, including sleep and awake organization
- More well-regulated cognitive and attentional functioning in various domains, including visual-motor integration, spatial planning, attentional planning, expressive and receptive language function, abstract verbal reasoning, short term memory and continuous performance regulation
- More well-regulated executive function capacities
- More well-regulated affective emotional functioning
Parents whose infants receive the support of a neuropsychoeducational model of care will show:
- At 2 weeks, 9 and 24 months post term, enhanced appreciation of their infant as an individual
- At 9 and 24 months post term, more sensitively attuned input in support of their child's functioning, more competent parenting strategies, and a greater sense of effectiveness in parenting the child.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inborn at the Brigham and Women's Hospital
- Gestational age < 36 weeks
- Birthweight < 5th percentile
- Head circumference at birth < 5th percentile
Exclusion Criteria:
- Presence of major chromosomal or congenital anomalies (Down's, Turner's, Klinefelter's Syndrome, etc.)
- Presence of major congenital infections (HIV, TORCH)
- Presence of significant prenatal focal brain lesions (intrauterine infarcts; cystic changes, etc.)
- Presence of major maternal illness (uncontrolled diabetes, active seizure disorder requiring medication during pregnancy, renal transplant), mental and/or emotional impairment (including heroin addiction and documented alcoholism)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evidence of improved neurodevelopmental and neurophysiological outcome as assessed with: Assessment of Preterm Infants' Behavior (APIB) and electrophysiological (EEG) assessment
Time Frame: At 2 weeks , 9 months and 24 months corrected age
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At 2 weeks , 9 months and 24 months corrected age
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heidelise Als, PhD, Boston Children's Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- X03-10-072R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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