Steroid Trial

Study Purpose
The purpose of the Steroid Trial was to compare the effect of early postnatal dexamethasone to selective late dexamethasone therapy in ventilated extremely low birth weight premature infants.

Study Design
Multicenter randomized double blinded controlled clinical trial in 43 Neonatal Intensive Care Units in Vermont Oxford Network.

Study Synopsis
The Steroid Trial enrolled and randomized 542 extremely low birth weight infants of 501-1000 grams to receive either early postnatal dexamethasone for 12 days or normal saline placebo. Intravenous dexamethasone was administered according to the following dosing schedule: 0.5mg/kg/d for three days, 0.25mg/kg/d for 3 days, 0.10 mg/kg/d for three days, and 0.05 mg/kg/d for 3 days. Infants in either group were permitted to receive selective late postnatal steroid therapy. The study was stopped due to concerns regarding serious side effects in the early postnatal steroid treatment group. More infants who received early steroid treatment had complications associated with therapy including hyperglycemia, and an increase in the use of insulin therapy. In the early steroid treatment group trends were noted towards increased risk of gastrointestinal hemorrhage, gastrointestinal perforation, and increased systolic blood pressure.

Status
Completed and Published.

Citation
The Vermont Oxford Network Steroid Study Group (2001). Early Postnatal Dexamethasone Therapy for the Prevention of Chronic Lung Disease. Pediatrics, 108(3), 741-748.

Study Sponsors
Our thanks to our sponsors: Children's Miracle Network