The multiple negative randomized controlled trials in perinatology--why?
Marya Strand, Alan H Jobe
https://pubmed.ncbi.nlm.nih.gov/14510325Actively Recruiting
Age: 0 - 14Days
All Genders
ID00063063
Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants
Led by NICHD Neonatal Research Network · Updated on 2026-03-16
80000
Participants Needed
31
Research Sites
N/A
Total Duration
On this page
Sponsors
N
NICHD Neonatal Research Network
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are maintaining a registry called the Generic Database (GDB) to collect data on very low birth weight infants born alive at NICHD Neonatal Research Network (NRN) centers. This registry gathers baseline and outcome information on both mothers and infants, focusing on infants weighing between 401 and 1000 grams or born before 29 weeks gestation. The collected data is not linked to a specific disease or treatment but is used to find associations and trends to support future research trials. The data collected includes demographics, maternal health, labor and delivery details, infant health status at birth, and medical outcomes such as respiratory support, infections, and mortality. Baseline information is collected soon after NICU admission, and outcome data is gathered at hospital discharge or death. The registry includes infants enrolled in other NRN trials or observational studies, allowing the inclusion of some infants outside the primary weight and gestational age criteria. Participants are observed without intervention, with data collection occurring throughout their hospital stay. Researchers collect detailed medical and demographic information from medical records and track outcomes over time. The main goal is to maintain a uniform, longitudinal database of very low birth weight infants to support analysis of treatment patterns and health outcomes. This registry has been active since 1987 and is funded through March 2030.
CONDITIONS
Brief Title
Generic Database of Very Low Birth Weight Infants
Who Can Participate
Age: 0 - 14Days
All Genders
Eligibility Criteria
You may qualify if you...
- Infants born at NICHD NRN centers
- Birth weight between 401 and 1000 grams, and/or
- Gestational age between 20 0/7 and 28 6/7 weeks (<29 weeks)
- Infants enrolled in other NICHD NRN interventional or observational studies
- Infants up to 14 days old
You will not qualify if you...
- Infants weighing more than 1000 grams at birth
- Infants older than 29 weeks gestational age
- Infants not meeting inclusion criteria unless enrolled in other NRN studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Data is collected soon after admission to the NICU
Surveillance
Duration - Until hospital discharge or death
Participants who undergo routine care are observed to collect baseline and outcome data including health status and medical outcomes.
Data is collected at discharge or death
Trial Site Locations
Total: 31 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of California - Los Angeles
Los Angeles, California, United States, 90025
Completed
3
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
4
University of California at San Diego
San Diego, California, United States, 92103-8774
Completed
5
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States, 92123
Actively Recruiting
6
Yale University
New Haven, Connecticut, United States, 06504
Completed
7
George Washington University
Washington D.C., District of Columbia, United States, 20052
Completed
8
University of Miami
Miami, Florida, United States, 33136
Completed
9
Emory University
Atlanta, Georgia, United States, 30303
Actively Recruiting
10
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Not Yet Recruiting
11
Indiana University
Indianapolis, Indiana, United States, 46202
Completed
12
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
13
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Completed
14
Harvard University
Cambridge, Massachusetts, United States, 02138
Completed
15
Wayne State University
Detroit, Michigan, United States, 48201
Completed
16
University of Mississippi Medical Center - Children's of Mississippi
Jackson, Mississippi, United States, 39216
Not Yet Recruiting
17
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Completed
18
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
19
University of Rochester
Rochester, New York, United States, 14642
Active, Not Recruiting
20
RTI International
Durham, North Carolina, United States, 27705
Active, Not Recruiting
21
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
22
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
23
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
24
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Active, Not Recruiting
25
Univeristy of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
26
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Active, Not Recruiting
27
University of Tennessee
Memphis, Tennessee, United States, 38163
Completed
28
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Actively Recruiting
29
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
30
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
31
University of Vermont
Burlington, Vermont, United States, 05405
Completed
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Research Team
R
Ravi M Patal, MD
A
Abhik Das, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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