MedTrace Logo

Preterm Fetal Growth Restriction and Developmental Care

NCT00166660 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-04-03

No results posted yet for this study

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).

Conditions

Interventions

BEHAVIORAL

NIDCAP (Newborn Individualized Developmental Care)

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.

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Heidelise Als, PhD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2008-12-31
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00166660 on ClinicalTrials.gov