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Preterm Fetal Growth Restriction and Developmental Care

Primary Purpose

Preterm Birth

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NIDCAP (Newborn Individualized Developmental Care)
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Preterm infants, Developmental Care, NIDCAP, Fetal Growth Restriction, Neurobehavior, APIB, MRI, EEG, Parent Stress

Eligibility Criteria

28 Weeks - 33 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Inborn at Brigham and Women's Hospital, Boston Gestational age ≥28 and ≤33 weeks Doppler diagnosed absent or reversed end-diastolic umbilical artery flow velocity Less than 5th percentile in birthweight and head circumference for gestational age Exclusion Criteria: Major chromosomal or congenital anomalies Major congenital infections Significant prenatal diagnosed focal brain lesions Uncontrolled maternal illness History of smoking, alcoholism, and use of illicit drugs History of significant maternal deprivation, abuse, or malnutrition No telephone access and/or insufficient English language facility

Sites / Locations

  • Brigham and Women's HospitalRecruiting
  • Children's Hospital BostonRecruiting

Outcomes

Primary Outcome Measures

Assessment of Preterm Infants' Behavior (APIB)
Quantified Electroencephalography (qEEG)
Magnetic Resonance Imaging(MRI)

Secondary Outcome Measures

Parent Stress Level

Full Information

First Posted
September 9, 2005
Last Updated
April 1, 2009
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00166660
Brief Title
Preterm Fetal Growth Restriction and Developmental Care
Official Title
Preterm Fetal Growth Restriction and Developmental Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity).
Detailed Description
The protocol aims to demonstrate the effectiveness of an intervention geared to significantly improve functional competence for preterm infants with fetal growth restriction (FGR). Incidence of FGR is estimated to be as high as 5% of the general obstetric population. Preterms with FGR are doubly jeopardized. Aside from much higher mortality rates they also show significantly increased morbidity rates, including significant learning disabilities and school failure (>50%). The intervention's underlying premise holds that it is far more effective to support the immature brain, which is compromised by FGR, to develop optimally before the infant reaches full term rather than to attempt to ameliorate increasingly deviant development after deviance has occurred. The goal of the project is to show the effectiveness of individualized developmental care and intervention, which begins with the FGR preterm infant's admission to the newborn intensive care unit (NICU) and extends to 2 weeks (w) after full term equivalent age or 2w CA (corrected age for prematurity). Intervention in the NICU is considered more advantageous for the infant's later development than delay of intervention until after discharge home. The proposal maintains that the last trimester of gestation is a critical period for brain development, especially when compromised by FGR. In-NICU intervention at this critical brain development time is expected to reduce the infants' hypersensitivity and reactivity while in the NICU, and to lead to reduction of the high incidence of behavioral problems in infancy, which frequently foreshadows later behavioral and learning problems as well as school failure. The study aims to test three related hypotheses: Individualized developmental NICU care and intervention will enhance FGR preterm infants' brain development both functionally and structurally. The in-NICU intervention will improve the parents' understanding of their infant's individuality and equip them to feel more competent as parents. The intervention itself, while individualized for each infant, will be quantifiable and reliably reproducible. The study will: Test the effectiveness of the intervention by assessing brain development and functional adaptation of a high risk preterm population (n=30) with documented intrauterine FGR and born between 28 and 33w gestational age. Assess the FGR preterm infants' neurodevelopment within one week from birth (baseline) and again at 2w CA (outcome). Compare the results on the effectiveness of the intervention for the FGR preterm infants to a recently studied cohort of appropriately grown (AGA) preterm infants born at comparable gestational ages, supported with the same intervention and measured in comparable ways. The primary infant measures proposed will be brain functional (EEG coherence, neurobehavioral functioning) and brain structural assessments (MRI). The goal will be to examine the direct causal connections and correlations among population characteristics, the intervention, and ultimate outcome at 2w CA. The project is expected to deliver comprehensive and substantive results in favor of the developmental NICU intervention for FGR preterm infants as well as for the earlier studied AGA population. The proposed study is expected to demonstrate intervention effectiveness in improving FGR preterm infants' neurodevelopment. It is anticipated that the intervention-based improvement in brain structure and function will set the stage for improvement in later performance, especially in terms of behavioral/emotional adaptation, learning and school achievement, which are all critical for life success.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Preterm infants, Developmental Care, NIDCAP, Fetal Growth Restriction, Neurobehavior, APIB, MRI, EEG, Parent Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
NIDCAP (Newborn Individualized Developmental Care)
Intervention Description
The NIDCAP 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 the 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 formally observed each infant's behavior weekly throughout the hospitalization, starting with the phase of the infant's initial stabilization, and then every seven days throughout hospital discharge and to 2wCA.
Primary Outcome Measure Information:
Title
Assessment of Preterm Infants' Behavior (APIB)
Time Frame
2 weeks corrected age (2w CA)
Title
Quantified Electroencephalography (qEEG)
Time Frame
2 weeks Corrected Age (2w CA)
Title
Magnetic Resonance Imaging(MRI)
Time Frame
2 weeks Corrected Age (2w CA)
Secondary Outcome Measure Information:
Title
Parent Stress Level
Time Frame
2 weeks Corrected Age (2w CA)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inborn at Brigham and Women's Hospital, Boston Gestational age ≥28 and ≤33 weeks Doppler diagnosed absent or reversed end-diastolic umbilical artery flow velocity Less than 5th percentile in birthweight and head circumference for gestational age Exclusion Criteria: Major chromosomal or congenital anomalies Major congenital infections Significant prenatal diagnosed focal brain lesions Uncontrolled maternal illness History of smoking, alcoholism, and use of illicit drugs History of significant maternal deprivation, abuse, or malnutrition No telephone access and/or insufficient English language facility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidelise Als, PhD
Phone
617-355-8249
Email
heidelise.Als@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidelise Als, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidelise Als, PhD
Phone
617-355-8249
Email
heidelise.als@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Simon Warfield, PhD
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidelise Als, PhD
Phone
617-355-8249
Email
heidelise.als@childrens.harvard.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
15060237
Citation
Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846.
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Preterm Fetal Growth Restriction and Developmental Care

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