Dexamethasone Therapy in VLBW Infants at Risk of CLD

Completed · Phase 3 · Has a placebo group

Conditions studied: Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia

In brief

Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known. This trial looked at the benefits and hazards of starting dexamethasone therapy at two weeks of age and four weeks of age in premature infants.

Key facts

Study ID

NCT00011362

Run by

NICHD Neonatal Research Network

People needed

371

Starts

1992-09-01

Expected to finish

1994-04-01

Last updated by the study team

2019-03-22

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 501 to 1500 grams
• 13 to 15 days old
• Respiratory-index score of greater than or equal to 2.4 that had been increasing or minimally decreasing during the previous 48 hours or a score of greater than or equal to 4.0 even if there had been improvement during the preceding 48 hours

You may not qualify if…

• Received glucocorticoid treatment after birth
• Had evidence or suspicious signs of sepsis as judged by the treating physician
• Major congenital anomaly of the cardiovascular, pulmonary, or central nervous system

Where it is running

• Stanford University — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• George Washington University — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Wayne State University — Detroit, Michigan, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Tennessee — Memphis, Tennessee, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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