At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 371 enrolled

Drug / intervention

Dexamethasone Early +1 moredrug

Likely dose

Dexamethasone Early 0.25 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00011362

NCT00011362Phase 3Completed

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Randomized Clinical Trial of Dexamethasone Therapy in Very-Low-Birth-Weight Infants at Risk for Chronic Lung Disease (CLD)

NICHD Neonatal Research Network·interventional·Posted Feb 19, 2001·Updated Mar 22, 2019

In Brief

A Phase 3 clinical trial evaluating Dexamethasone Early and Dexamethasone Late for Infant, Newborn and 4 related conditions. Completed, enrolled 371 participants across 13 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia

CountriesUnited States

CollaboratorsNational Center for Research Resources (NCRR)

Timeline

Phase 3CompletedFinished

199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 1992

Primary CompletionJan 1994

Study CompletionApr 1994

First PostedFeb 2001

TodayJul 2026

First PostedFeb 19, 2001

Enrollment StartSep 1, 1992

Primary CompletionJan 1, 1994

Study CompletionApr 1, 1994

TodayJul 1, 2026

Enrollment to primary: 1.3 yearsPosted 25.4 years ago

Interventions

Dexamethasone Earlydrug

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.

Dexamethasone Latedrug

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