Preterm Fetal Growth Restriction and Developmental Care

Status unconfirmed · Phase 2

Conditions studied: Preterm Birth

In brief

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).

Key facts

Study ID

NCT00166660

Run by

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

People needed

30

Starts

2004-07-01

Expected to finish

2009-06-01

Last updated by the study team

2009-04-03

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Children's Hospital Boston — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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