NCT00005777

Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)

Randomized Trial of Minimal Ventilator Support and Early Corticosteroid Therapy to Increase Survival Without Chronic Lung Disease in Extremely-Low-Birth-Weight Infants

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 5 Minutes – 10 Days
• Healthy volunteers: Not accepted

Summary

This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide \[PCO(2)\] target \>52 mm Hg) or routine ventilation (PCO(2) target \<48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge. The infants' neurodevelopment was evaluated at 18-22 months corrected age.

Detailed description

Chronic lung disease (CLD), also known as bronchopulmonary dysplasia (BPD), in very premature infants has been associated with mechanical ventilation and relative adrenal insufficiency. This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide \[PCO(2)\] target \>52 mm Hg) or routine ventilation (PCO(2) target \<48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge. The trial was terminated by the Steering Committee when the interim analysis for the Data Safety and Monitoring Committee showed a higher rate of spontaneous gastrointestinal perforations in the dexamethasone-treated infants. Neurodevelopment was assessed at 18-22 months postmenstrual age.

Conditions

• Bronchopulmonary Dysplasia
• Respiratory Distress Syndrome
• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature

Interventions

Type	Name	Description
PROCEDURE	Minimal mechanical ventilation management	Partial pressure of carbon dioxide (PCO2) target (\>52 mm Hg)
PROCEDURE	Routine mechanical ventilation management	Partial pressure of carbon dioxide (PCO2) target \<48 mm Hg)
DRUG	Dexamethasone	Treatment with the study medication was initiated within 24 hours after birth. The dexamethasone-treated infants received a 10-day tapered course (0.15 mg of dexamethasone per kilogram per day for three days, followed by 0.10 mg per kilogram for three days, 0.05 mg per kilogram for two days, and 0.02 mg per kilogram for two days), with the daily dose divided in half and given at 12-hour intervals intravenously or orally, if an intravenous catheter was no longer in place.
DRUG	Placebo	The infants in the placebo groups received equal volumes of saline.

Timeline

• Start date: 1998-02-01
• Primary completion: 1998-09-01
• Completion: 2002-09-01
• First posted: 2000-06-02
• Last updated: 2015-06-08

Locations

13 sites across 1 country: United States