Follow-up Visit of High Risk Infants

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
NICHD Neonatal Research Network
Study ID
NCT00009633
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
18 Months - 26 Months
Healthy Volunteers
Not accepted

Interventions

  • No Intervention — OTHER
    No Intervention

Study Details

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.

Key Dates

Start date
Apr 1, 1993
Status verified
Feb 2025
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
68,000 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 3/31/2016 ]

Central Contacts

Locations (31)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Waldemar A. Carlo, MD
Waldemar A. Carlo, MD (PRINCIPAL_INVESTIGATOR)
Myriam Peralta-Carcelen, MD MPH (PRINCIPAL_INVESTIGATOR)
University of California - Los AngelesLos AngelesCalifornia90025
Uday Devaskar, MD
Uday Devaskar, MD (PRINCIPAL_INVESTIGATOR)
Isabell Purdy, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityPalo AltoCalifornia94304
Krisa P. Van Meurs, MD
Krisa P. Van Meurs, MD (PRINCIPAL_INVESTIGATOR)
Susan R. Hintz, 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)
Ira Adams-Chapman, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Lurie Children's Hospital of ChicagoChicagoIllinois60611
Aaron Hamvas, MD
Aaron Hamvas, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Greg Sokol, MD
Greg Sokol, MD (PRINCIPAL_INVESTIGATOR)
Heidi Harmon, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Edward F. Bell, MD
Edward F. Bell, MD (PRINCIPAL_INVESTIGATOR)
Jane E. Brumbaugh, MD (PRINCIPAL_INVESTIGATOR)
Tufts Medical CenterBostonMassachusetts02111-
Harvard UniversityCambridgeMassachusetts02138-
Wayne State UniversityDetroitMichigan48201
Seetha Shankaran, MD
Seetha Shankaran, MD (PRINCIPAL_INVESTIGATOR)
University of Mississippi Medical Center - Children's of MississippiJacksonMississippi39216
Abhay Bhatt, MD
Abhay Bhatt, MD (PRINCIPAL_INVESTIGATOR)
Children's Mercy HospitalKansas CityMissouri64108
William Truog, MD
William Truog, MD (PRINCIPAL_INVESTIGATOR)
Howard Kilbride, MD (PRINCIPAL_INVESTIGATOR)
University of New MexicoAlbuquerqueNew Mexico87131
Kristi L. Watterberg, MD
Kristi L. Watterberg, MD (PRINCIPAL_INVESTIGATOR)
Janell Fuller, MD (PRINCIPAL_INVESTIGATOR)
Jean Lowe, MD (PRINCIPAL_INVESTIGATOR)
University of RochesterRochesterNew York14642-
Wake Forest UniversityCharlotteNorth Carolina27157-
Duke UniversityDurhamNorth Carolina27710
C. Michael Cotten, MD
C. Michael Cotten, MD (PRINCIPAL_INVESTIGATOR)
William F. Malcolm, MD (PRINCIPAL_INVESTIGATOR)
RTI InternationalDurhamNorth Carolina27705-
Cincinnati Children's Medical CenterCincinnatiOhio45267
Brenda Poindexter, MD,MS
Brenda Poindexter, MD (PRINCIPAL_INVESTIGATOR)
Stephanie Merhar, MD (PRINCIPAL_INVESTIGATOR)
Kimberly Yolton, PhD (PRINCIPAL_INVESTIGATOR)
Case Western Reserve University, Rainbow Babies and Children's HospitalClevelandOhio44106
Michele C. Walsh, MD MS
Michele C. Walsh, MD MS (PRINCIPAL_INVESTIGATOR)
Deanne E. Wilson, MD (PRINCIPAL_INVESTIGATOR)
Research Institute at Nationwide Children's HospitalColumbusOhio43205-
University of PennsylvaniaPhiladelphiaPennsylvania19104
Eric Eichenwald, MD
Eric Eichenwald, MD (PRINCIPAL_INVESTIGATOR)
Sara DeMauro, 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. Wyckfoff, MD (PRINCIPAL_INVESTIGATOR)
Roy J. Heyne, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at HoustonHoustonTexas77030
Jon Tyson, MD MPH
Jon E. Tyson, MD MPH (PRINCIPAL_INVESTIGATOR)
Andrea F. Duncan, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84108
Bradley Yoder, MD
Bradley Yoder, MD (PRINCIPAL_INVESTIGATOR)
Sara Winter, MD (PRINCIPAL_INVESTIGATOR)

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