Dexamethasone Therapy in VLBW Infants at Risk of CLD
- Conditions
- Infant, NewbornInfant, Low Birth WeightInfant, PrematureInfant, Small for Gestational AgeBronchopulmonary Dysplasia
- Interventions
- Registration Number
- NCT00011362
- Lead Sponsor
- NICHD Neonatal Research Network
- Brief 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.
- Detailed Description
Ventilator-dependent premature infants are often treated with dexamethasone. However, the optimal timing of therapy is unknown. We compared the benefits and hazards of initiating dexamethasone therapy at two weeks of age and at four weeks of age in 371 ventilator-dependent very-low-birth-weight infants (501 to 1500 grams) who had respiratory-index scores (mean airway pressure x the fraction of inspired oxygen) of greater than or equal 2.4 at two weeks of age. The primary outcome was the number of days from randomization to extubation not requiring reintubation (extubation score or death). The secondary outcomes were death before discharge from the hospital; the duration of assisted ventilation, supplementary oxygen therapy and hospital stay; the incidence of chronic lung disease (defined as the need for supplemental oxygen at 36 weeks postconceptional age by best obstetrical estimate) and rates of morbidity and mortality from respiratory causes during the first year. Additional secondary endpoints were hyperglycemia, hypertension, growth, bacteremia, necrotizing enterocolitis and upper GI bleeding.
The sample size of 370 was based on a 0.60 probability that the extubation score of late treatment was greater than early treatment, a 5% two-sided type 1 error, 85% power, and 10% treatment noncompliance.
Infants were randomized to either receive dexamethasone for two weeks followed by saline placebo for two weeks, or saline placebo for two weeks followed by either dexamethasone or additional placebo for two weeks (if they still met entry criteria). Dexamethasone was given at a dose of 0.25 mg per kilogram of body weight twice daily intravenously or orally for five days, and the dose then tapered.
The median time to ventilator independence was 36 days in the dexamethasone-placebo group and 37 days in the placebo-dexamethasone group. The incidences of chronic lung disease (defined as the need for oxygen supplementation at 36 weeks postconceptional age) were 66 percent and 67 percent, respectively. Dexamethasone was associated with an increased incidence of nosocomial bacteremia (relative risk, 1.5; 95 percent confidence interval, 1.1 to 2.1) and hyperglycemia (relative risk, 1.9; 95 percent confidence interval, 1.2 to 3.0) in the dexamethasone-placebo group, elevated blood pressure (relative risk, 2.9; 95 percent confidence interval, 1.2 to 6.9) in the placebo-dexamethasone group, and diminished weight gain and head growth (P less than 0.001) in both groups. Treatment of ventilator-dependent premature infants with dexamethasone at two weeks of age is more hazardous and no more beneficial than treatment at four weeks of age.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 371
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexamethasone Dexamethasone Early Dexamethasone Dexamethasone Dexamethasone Late Dexamethasone Placebo Dexamethasone Early Saline Placebo Dexamethasone Late Saline
- Primary Outcome Measures
Name Time Method Number of days from randomization to ventilator independence, defined as extubation not requiring reintubation, or extubation followed by elective reintubation for seven days or less so that the infant could undergo a surgical procedure At hospital discharge
- Secondary Outcome Measures
Name Time Method Morbidity and mortality from respiratory causes during the first year 12 months of age Death before discharge from the hospital At hospital discharge Duration of assisted ventilation At hospital discharge Duration of supplemental oxygen therapy At hospital discharge Duration of hospital stay At hospital discharge Incidence of chronic lung disease At hospital discharge
Trial Locations
- Locations (13)
Yale University
🇺🇸New Haven, Connecticut, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
University of Miami
🇺🇸Miami, Florida, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Stanford University
🇺🇸Palo Alto, California, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of Tennessee
🇺🇸Memphis, Tennessee, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Cincinnati Children's Medical Center
🇺🇸Cincinnati, Ohio, United States
Brown University, Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States