Dexamethasone Therapy in VLBW Infants at Risk of CLD

PHASE3CompletedINTERVENTIONAL
Enrollment

371

Participants

Timeline

Start Date

September 30, 1992

Primary Completion Date

January 31, 1994

Study Completion Date

April 30, 1994

Conditions
Infant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, PrematureBronchopulmonary Dysplasia
Interventions
DRUG

Dexamethasone Early

Tapering course of dexamethasone in doses given twice a day (0.25 mg per kilogram of body weight per dose for five days, then 0.15 mg, 0.07 mg, and 0.03 mg per kilogram per dose for three days each), followed by two weeks of saline.

DRUG

Dexamethasone Late

Saline for two weeks, followed by either the same tapering two-week course of dexamethasone given to the first group, if the respiratory-index score was \>=2.4 on treatment day 14, or an additional two weeks of saline

Trial Locations (13)

20052

George Washington University, Washington D.C.

30303

Emory University, Atlanta

33136

University of Miami, Miami

38163

University of Tennessee, Memphis

44106

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

45267

Cincinnati Children's Medical Center, Cincinnati

46202

Indiana University, Indianapolis

48201

Wayne State University, Detroit

75235

University of Texas Southwestern Medical Center at Dallas, Dallas

87131

University of New Mexico, Albuquerque

94304

Stanford University, Palo Alto

06504

Yale University, New Haven

02905

Brown University, Women & Infants Hospital of Rhode Island, Providence

All Listed Sponsors
collaborator

National Center for Research Resources (NCRR)

NIH

lead

NICHD Neonatal Research Network

NETWORK

NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD | Biotech Hunter | Biotech Hunter