RECRUITING

Generic Database of Very Low Birth Weight Infants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants

Quick Facts

Study Start:1987-01
Study Completion:2030-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00063063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 14 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Infants inborn at NICHD NRN centers that are:
  2. * 401-1000 grams birth weight, and/or
  3. * 20 0/7 to 28 6/7 weeks (\<29 weeks) gestational age
  4. * 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.
  1. * Infants \>1,000 grams birth weight and/or \>29 weeks gestational age

Contacts and Locations

Study Contact

Ravi M Patal, MD
CONTACT
404-727-5905
rmpatel@emory.edu
Abhik Das, PhD
CONTACT
301-230-4640
adas@rti.org

Principal Investigator

Abbot R Laptook, MD
PRINCIPAL_INVESTIGATOR
Brown University, Women & Infants Hospital of Rhode Island
Anna Maria Hibbs, MD, MSCE, FAAP
PRINCIPAL_INVESTIGATOR
Case Western Reserve University, Rainbow Babies and Children's Hospital
C. Michael Cotten, MD
PRINCIPAL_INVESTIGATOR
Duke University
Ravi M Patel, MD, MSc
STUDY_CHAIR
Emory University
Abhik Das, PhD
PRINCIPAL_INVESTIGATOR
RTI International
Krisa P Van Meurs, MD
PRINCIPAL_INVESTIGATOR
Stanford University
Stephanie Merhar, MD MS
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Waldemar A Carlo, MD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Tarah Colaizy, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Iowa
Kristi L Watterberg, MD
PRINCIPAL_INVESTIGATOR
University of New Mexico
Myra Wyckoff, MD
PRINCIPAL_INVESTIGATOR
University of Texas, Southwestern Medical Center at Dallas
Jon E Tyson, MD MPH
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Sara DeMauro, MD, MSCE
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Carl D'Angio, MD
PRINCIPAL_INVESTIGATOR
University of Rochester
Pablo Sanchez, MD
PRINCIPAL_INVESTIGATOR
Research Institute at Nationwide Children's Hospital
Robin Ohls, MD
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
University of California - Los Angeles
Los Angeles, California, 90025
United States
Stanford University
Palo Alto, California, 94304
United States
University of California at San Diego
San Diego, California, 92103-8774
United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
United States
Yale University
New Haven, Connecticut, 06504
United States
George Washington University
Washington, District of Columbia, 20052
United States
University of Miami
Miami, Florida, 33136
United States
Emory University
Atlanta, Georgia, 30303
United States
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Indiana University
Indianapolis, Indiana, 46202
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Harvard University
Cambridge, Massachusetts, 02138
United States
Wayne State University
Detroit, Michigan, 48201
United States
University of Mississippi Medical Center - Children's of Mississippi
Jackson, Mississippi, 39216
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States
University of Rochester
Rochester, New York, 14642
United States
RTI International
Durham, North Carolina, 27705
United States
Duke University
Durham, North Carolina, 27710
United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
United States
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Univeristy of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
United States
University of Tennessee
Memphis, Tennessee, 38163
United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84108
United States
University of Vermont
Burlington, Vermont, 05405
United States

Collaborators and Investigators

Sponsor: NICHD Neonatal Research Network

  • Abbot R Laptook, MD, PRINCIPAL_INVESTIGATOR, Brown University, Women & Infants Hospital of Rhode Island
  • Anna Maria Hibbs, MD, MSCE, FAAP, PRINCIPAL_INVESTIGATOR, Case Western Reserve University, Rainbow Babies and Children's Hospital
  • C. Michael Cotten, MD, PRINCIPAL_INVESTIGATOR, Duke University
  • Ravi M Patel, MD, MSc, STUDY_CHAIR, Emory University
  • Abhik Das, PhD, PRINCIPAL_INVESTIGATOR, RTI International
  • Krisa P Van Meurs, MD, PRINCIPAL_INVESTIGATOR, Stanford University
  • Stephanie Merhar, MD MS, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati
  • Waldemar A Carlo, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham
  • Tarah Colaizy, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Iowa
  • Kristi L Watterberg, MD, PRINCIPAL_INVESTIGATOR, University of New Mexico
  • Myra Wyckoff, MD, PRINCIPAL_INVESTIGATOR, University of Texas, Southwestern Medical Center at Dallas
  • Jon E Tyson, MD MPH, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston
  • Sara DeMauro, MD, MSCE, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
  • Carl D'Angio, MD, PRINCIPAL_INVESTIGATOR, University of Rochester
  • Pablo Sanchez, MD, PRINCIPAL_INVESTIGATOR, Research Institute at Nationwide Children's Hospital
  • Robin Ohls, MD, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date1987-01
Study Completion Date2030-03-31

Study Record Updates

Study Start Date1987-01
Study Completion Date2030-03-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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