80000 Participants Needed

Generic Database of Very Low Birth Weight Infants

(GDB Trial)

Recruiting at 18 trial locations
EF
AD
RM
Overseen ByRavi M Patal, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: NICHD Neonatal Research Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

RO

Robin Ohls, MD

Principal Investigator

University of Utah

AM

Anna Maria Hibbs, MD, MSCE, FAAP

Principal Investigator

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

WA

Waldemar A Carlo, MD

Principal Investigator

University of Alabama at Birmingham

CM

C. Michael Cotten, MD

Principal Investigator

Duke University

KL

Kristi L Watterberg, MD

Principal Investigator

University of New Mexico

SD

Sara DeMauro, MD, MSCE

Principal Investigator

University of Pennsylvania

AR

Abbot R Laptook, MD

Principal Investigator

Brown University, Women & Infants Hospital of Rhode Island

RM

Ravi M Patel, MD, MSc

Principal Investigator

Emory University

PS

Pablo Sanchez, MD

Principal Investigator

Research Institute at Nationwide Children's Hospital

AD

Abhik Das, PhD

Principal Investigator

RTI International

KP

Krisa P Van Meurs, MD

Principal Investigator

Stanford University

CD

Carl D'Angio, MD

Principal Investigator

University of Rochester

SM

Stephanie Merhar, MD MS

Principal Investigator

Children's Hospital Medical Center, Cincinnati

MW

Myra Wyckoff, MD

Principal Investigator

University of Texas, Southwestern Medical Center at Dallas

TC

Tarah Colaizy, MD, MPH

Principal Investigator

University of Iowa

JE

Jon E Tyson, MD MPH

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Baseline data is collected soon after admission to the NICU; outcome data is collected at the time of death or discharge from the hospital

Duration of NICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

Until discharge or death

Longitudinal Data Analysis

Data are analyzed to find associations and trends between baseline information, treatments, and infant outcomes

Through 3/31/2030

What Are the Treatments Tested in This Trial?

Interventions

  • None
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Registry CohortExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NICHD Neonatal Research Network

Lead Sponsor

Trials
62
Recruited
209,000+

National Center for Research Resources (NCRR)

Collaborator

Trials
540
Recruited
317,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+
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