Recruiting

Observational Study

Sponsor:

NICHD Neonatal Research Network

Code:

NCT00009633

Conditions

Infant, Newborn

Infant, Low Birth Weight

Infant, Small for Gestational Age

Infant, Premature

Eligibility Criteria

Sex: All

Age: 1 - 2

Healthy Volunteers: Not accepted

Interventions

No Intervention

Study Details

Brief summary:

The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.

Conditions

Infant, Newborn

Infant, Low Birth Weight

Infant, Small for Gestational Age

Infant, Premature

Study ID

NCT00009633

Start date

Apr 1, 1993

Status verified date

Jun, 2026

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 2

Healthy Volunteers: Not accepted

  • Infants inborn at NRN centers
  • <27 weeks gestational age
  • Infants enrolled in one or more additional NICHD NRN Follow-up studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and/or older than 27 weeks may be included in the FU Study.

Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, infants with birth weights between 401 and 1500 grams who were admitted to NRN NICUs within 14 days of birth were included in the database.

Study Design

Enrollment

68000 participants

Anticipated

Interventions and Outcome Measures

Arms

Registry Cohort

Registry Cohort

Interventions

No Intervention

No Intervention

Primary outcome measure

  • To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner [ Time Frame: Longitudinal database currently funded through 3/31/2016 ]

Central Contacts and Locations

Central contacts

Susan R Hintz, MD, MS Epi

srhintz@stanford.edu

Abhik Das, PhD

301 230 4640adas@rti.org

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Principal Investigator:

Waldemar A. Carlo, MD

University of California - Los Angeles

Recruiting

Los Angeles, California, United States, 90025

Principal Investigator:

Uday Devaskar, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Principal Investigator:

Krisa P. Van Meurs, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30303

Principal Investigator:

David P. Carlton, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Greg Sokol, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator:

Edward F. Bell, MD

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Principal Investigator:

Seetha Shankaran, MD

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Principal Investigator:

William Truog, MD

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Principal Investigator:

Kristi L. Watterberg, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

C. Michael Cotten, MD

Cincinnati Children's Medical Center

Recruiting

Cincinnati, Ohio, United States, 45267

Principal Investigator:

Brenda Poindexter, MD

Case Western Reserve University, Rainbow Babies and Children's Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Michele C. Walsh, MD MS

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Eric Eichenwald, MD

University of Texas Southwestern Medical Center at Dallas

Recruiting

Dallas, Texas, United States, 75235

Principal Investigator:

Myra H. Wyckfoff, MD

University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Jon E. Tyson, MD MPH

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Principal Investigator:

Bradley Yoder, MD

More Information

Sponsor

NICHD Neonatal Research Network

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • NICHD Neonatal Research Network
  • Extremely Low Birth Weight (ELBW)
  • Prematurity
  • Neurodevelopmental Outcome
  • Follow up studies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NICHD Neonatal Research Network on 2026-07-01.