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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Page 1 of 1 (2 locations)

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

2

Children's Hospital Boston

Boston, Massachusetts, United States, 02115