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Infant Mortality |
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Clinical Trial: Follow-Up Study of Extremely Low Birth Weight (ELBW) Infants
This study is currently recruiting patients.
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Purpose
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants (approximately 2 pounds) born in participating Network centers will receive neurodevelopmental, neurosensory and functional assessment at 18-22 months corrected age. Data regarding pregnancy and neonatal outcome are collected prospectively. The goal of the study is to identify maternal and neonatal risk and protective factors for neurodevelopmental outcome.
| Condition | Phase |
|---|---|
| Infant, Newborn, Diseases | Phase IV |
MedlinePlus related topics: Infant and Toddler Health
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Neurodevelopmental Follow-Up of Extremely Low Birth Weight (ELBW) Infants
Study start: January 1993
A multi-center cohort study in which surviving extremely low birth-weight infants undergo neurodevelopmental, neurosensory and functional assessment at 18-22 months corrected age. Data regarding pregnancy and neonatal outcome are collected prospectively. Social and economic status information (SES) and a detailed interim medical history are obtained at the time of the assessment. The scheduled evaluations at 18 - 22 months corrected age include: demographic information; socioeconomic status; medical history; medications; medical equipment required; growth data; a detailed neurologic examination; Bayley Scales of Infant Development (mental, motor, infant behavior); Family Resource Scale; Stein Functional Status II Measure and the Stein Impact on the Family Scale.
The goal of the study is to identify maternal and neonatal risk and protective factors for neurodevelopmental outcome. Additional objectives of the study include: to characterize development in the areas of motor skills, cognitive skills, language and behavior; to determine the mortality and the prevalence of specific medical morbidities in ELBW infants; to characterize the relationship between growth and neurodevelopmental outcome; to assess the relationship between the socioeconomic status and developmental outcome; to identify significant family stress in this population and compliance with medical and developmental care; to assess the utilization of special support services and early intervention programs by this population; and finally, to evaluate the need for follow-up to school age. The Follow-Up Study has maintained its goal of greater than or equal to 80 percent follow-up compliance rate.
Eligibility
Ages Eligible for Study: 18 Months - 24 Months, Genders Eligible for Study: Both
Criteria
- < 1000 g at birth
- Patient enrolled at a Neonatal Research Network center
Location and Contact Information
Alabama
University of Alabama, Birmingham, Alabama, United States; Recruiting
Kathleen Nelson, MD, Principal Investigator
California
Stanford University, Stanford, California, United States; Recruiting
Toby Cohen, MD, Principal Investigator
Connecticut
Yale University, New Haven, Connecticut, United States; Recruiting
Linda Mayes, MD, Principal Investigator
Florida
University of Miami, Miami, Florida, United States; Recruiting
Charles Bauer, MD, Principal Investigator
Georgia
Emory University, Atlanta, Georgia, United States; Recruiting
Neal Simon, MD, Principal Investigator
Michigan
Wayne State University, Detroit, Michigan, United States; Recruiting
Virginia Delaney-Black, MD, Principal Investigator
New Mexico
University of New Mexico, Albuquerque, New Mexico, United States; Recruiting
Ohio
Case Western Reserve University, Cleveland, Ohio, United States; Recruiting
Dee Wilson, MD, Principal Investigator
University of Cincinnati, Cincinnati, Ohio, United States; Recruiting
Jean Steichen, MD, Principal Investigator
Rhode Island
Brown University, Providence, Rhode Island, United States; Recruiting
Betty Vohr, MD, Principal Investigator
Tennessee
University of Tennessee, Memphis, Tennessee, United States; Recruiting
Henrietta Bada, MD, Principal Investigator
Texas
University of Texas, Dallas, Texas, United States; Recruiting
Sue Broyles, MD, Principal Investigator
University of Texas, Houston, Texas, United States; Recruiting
Brenda Morris, MD, Principal Investigator
Betty Vohr, MD, Principal Investigator, Brown University
More Information
Click here for more information on NICHD clinical trials.
Click here for more information on the NICHD Neonatal Research Network.
Record last reviewed: October 2003
Last Updated: October 13, 2004
Record first received: February 1, 2001
ClinicalTrials.gov Identifier: NCT00009633
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- "Closing the Health Gap": Reducing Health Disparities Affecting African-Americans (Office of Minority Health, OPHS, OS, HHS)
- Health Disparities: Bridging the Gap (National Institute of Child Health and Human Development Clearinghouse, NICHD, NIH, HHS)
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