Recruiting

Observational Study

Sponsor:

NICHD Neonatal Research Network

Code:

NCT00063063

Conditions

Infant, Newborn

Infant, Low Birth Weight

Infant, Small for Gestational Age

Infant, Premature

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

No Intervention

Study Details

Brief summary:

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

Conditions

Infant, Newborn

Infant, Low Birth Weight

Infant, Small for Gestational Age

Infant, Premature

Study ID

NCT00063063

Start date

Apr 1, 1987

Status verified date

Mar, 2026

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Infants inborn at NICHD NRN centers that are:
  • 401-1000 grams birth weight, and/or
  • 20 0/7 to 28 6/7 weeks (<29 weeks) gestational age
  • Infants enrolled in one or more additional NICHD NRN interventional trials or time-limited observational studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria for the Generic Database 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 29 weeks may be included in the GDB.

Exclusion Criteria:

  • Infants >1,000 grams birth weight and/or >29 weeks gestational age

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

Study Design

Enrollment

80000 participants

Anticipated

Interventions and Outcome Measures

Arms

Registry Cohort

Registry Cohort

Interventions

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 3/31/2030 ]

Central Contacts and Locations

Central contacts

Ravi M Patal, MD

404-727-5905rmpatel@emory.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

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Principal Investigator:

Krisa P. Van Meurs, MD

Sharp Mary Birch Hospital for Women & Newborns

Recruiting

San Diego, California, United States, 92123

Principal Investigator:

Anup Katheria, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30303

Principal Investigator:

David P Carlton, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator:

Edward F. Bell, 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, MHS

Cincinnati Children's Medical Center

Recruiting

Cincinnati, Ohio, United States, 45267

Principal Investigator:

Brenda Poindexter, MD MS

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

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Michele C. Walsh, MD MS

Univeristy 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 Wyckoff, 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

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • NICHD Neonatal Research Network
  • Extremely Low Birth Weight (ELBW)
  • Prematurity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NICHD Neonatal Research Network on 2026-03-16.