Open randomised controlled trial of inhaled nitric oxide and early dexamethasone in high risk preterm infants

• Published in: Archives of disease in childhood. Fetal and neonatal edition Vol. 77; no. 3; pp. F185 - F190
• Main Authors: Subhedar, N V, Ryan, S W, Shaw, N J
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health 01.11.1997; BMJ; BMJ Publishing Group LTD
• Subjects: Administration, Inhalation; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - therapeutic use; Biological and medical sciences; Chronic Disease; chronic lung disease; dexamethasone; Dexamethasone - administration & dosage; Dexamethasone - therapeutic use; Drug Therapy, Combination; Female; Humans; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases - prevention & control; Infants; Lung Diseases - prevention & control; Male; Medical sciences; Mortality; Nitric oxide; Nitric Oxide - administration & dosage; Nitric Oxide - therapeutic use; Original; Pharmacology. Drug treatments; Premature birth; randomised controlled trial; Respiratory distress syndrome; Respiratory system; Respiratory therapy; Risk Factors; Studies; Survival Rate; Treatment Outcome; Human; Premature; Lung disease; Dexamethasone; Intravenous administration; Pregnancy disorders; Respiratory disease; Toxicity; Treatment efficiency; Infant; Inhalation; Newborn diseases; Chemotherapy; Randomization; Controlled environment study; Treatment; Prematurity; Nitric oxide; Clinical trial; Severity score
• ISSN: 1359-2998; 1468-2052
• DOI: 10.1136/fn.77.3.F185

AIM To determine whether treatment with inhaled nitric oxide (NO) and/or dexamethasone reduces the incidence of chronic lung disease (CLD) and/or death in high risk preterm infants. METHODS Infants below 32 weeks of gestation were recruited at 96 hours of age if they were deemed to be at high risk of developing CLD. Infants were randomly assigned to one of four treatment groups using a factorial design: (1) 5–20 parts per million inhaled NO for 72 hours; (2) 0.5–1 mg/kg/day intravenous dexamethasone for 6 days; (3) both drugs together; (4) continued conventional management. RESULTS Forty two infants were randomised: 10 infants received inhaled NO alone; 11 dexamethasone alone; 10 both treatments; and 11 neither treatment. There was no difference in the combined incidence of CLD and/or death before discharge from hospital between either infants treated with inhaled NO and controls (RR 1.05, 95% CI 0.84–1.25), or those treated with dexamethasone and controls (RR 0.95, 95% CI 0.79–1.18). CONCLUSIONS At 96 hours of age, neither treatment with inhaled NO nor dexamethasone prevented CLD or death.