Status:
UNKNOWN
Preterm Fetal Growth Restriction and Developmental Care
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Preterm Birth
Eligibility:
All Genders
28-33 years
Phase:
PHASE2
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 (NIC...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00166660
Start Date
July 1 2004
End Date
June 1 2009
Last Update
April 3 2009
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Children's Hospital Boston
Boston, Massachusetts, United States, 02115