Generic Database of Very Low Birth Weight Infants

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
NICHD Neonatal Research Network
Study ID
NCT00063063
Status
Recruiting
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Conditions

  • Infant, Low Birth Weight
  • Infant, Newborn
  • Infant, Premature
  • Infant, Small for Gestational Age

Eligibility Criteria

Sex
ALL
Age
N/A - 14 Days
Healthy Volunteers
Not accepted

Interventions

  • No Intervention — OTHER

Study Details

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.

Key Dates

Start date
Apr 1, 1987
Status verified
Mar 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
80,000 participants (estimated)

Arms

  • Arm: Registry Cohort
    Registry Cohort

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

Locations (31)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Waldemar A. Carlo, MD
Waldemar A. Carlo, MD (PRINCIPAL_INVESTIGATOR)
University of California - Los AngelesLos AngelesCalifornia90025-
Stanford UniversityPalo AltoCalifornia94304
Krisa P. Van Meurs, MD
Krisa P. Van Meurs, MD (PRINCIPAL_INVESTIGATOR)
Sharp Mary Birch Hospital for Women & NewbornsSan DiegoCalifornia92123
Anup Katheria, MD
Anup Katheria, MD (PRINCIPAL_INVESTIGATOR)
University of California at San DiegoSan DiegoCalifornia92103-8774-
Yale UniversityNew HavenConnecticut06504-
George Washington UniversityWashington D.C.District of Columbia20052-
University of MiamiMiamiFlorida33136-
Emory UniversityAtlantaGeorgia30303
David P Carlton, MD
David P Carlton, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Lurie Children's Hospital of ChicagoChicagoIllinois60611
Aaron Hamvas, MD
Aaron Hamvas, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202-
University of IowaIowa CityIowa52242
Edward F. Bell, MD
Edward F. Bell, MD (PRINCIPAL_INVESTIGATOR)
Tufts Medical CenterBostonMassachusetts02111-
Harvard UniversityCambridgeMassachusetts02138-
Wayne State UniversityDetroitMichigan48201-
University of Mississippi Medical Center - Children's of MississippiJacksonMississippi39216
Abhay Bhatt, MD
Abhay Bhatt, MD (PRINCIPAL_INVESTIGATOR)
Children's Mercy HospitalKansas CityMissouri64108-
University of New MexicoAlbuquerqueNew Mexico87131
Kristi L. Watterberg, MD
Kristi L. Watterberg, MD (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14642-
Duke UniversityDurhamNorth Carolina27710
C. Michael Cotten, MD, MHS
C. Michael Cotten, MD, MHS (PRINCIPAL_INVESTIGATOR)
RTI InternationalDurhamNorth Carolina27705-
Cincinnati Children's Medical CenterCincinnatiOhio45267
Brenda Poindexter, MD MS
Brenda Poindexter, MD MS (PRINCIPAL_INVESTIGATOR)
Case Western Reserve University, Rainbow Babies and Children's HospitalClevelandOhio44106
Michele C. Walsh, MD MS
Michele C. Walsh, MD MS (PRINCIPAL_INVESTIGATOR)
Research Institute at Nationwide Children's HospitalColumbusOhio43205-
Univeristy of PennsylvaniaPhiladelphiaPennsylvania19104
Eric Eichenwald, MD
Eric Eichenwald, MD (PRINCIPAL_INVESTIGATOR)
Brown University, Women & Infants Hospital of Rhode IslandProvidenceRhode Island02905-
University of TennesseeMemphisTennessee38163-
University of Texas Southwestern Medical Center at DallasDallasTexas75235
Myra H Wyckoff, MD
Myra H Wyckoff, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at HoustonHoustonTexas77030
Jon E. Tyson, MD MPH
Jon E. Tyson, MD MPH (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84108
Bradley Yoder, MD
Bradley Yoder, MD (PRINCIPAL_INVESTIGATOR)
University of VermontBurlingtonVermont05405-

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