PICO Summary: Does inhaled nitric oxide (iNO) decrease the rates of death, bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), or neurodevelopmental disability in preterm newborn infants with early signs of respiratory failure?

✍ Scribed by EBCH Editorial Office

• Publisher: John Wiley and Sons
• Year: 2010
• Tongue: English
• Weight: 64 KB
• Volume: 5
• Category: Article
• ISSN: 1557-6272
• DOI: 10.1002/ebch.477

✦ Synopsis

Does inhaled nitric oxide (iNO) decrease the rates of death, bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), or neurodevelopmental disability in preterm newborn infants with early signs of respiratory failure?

Background

Respiratory failure in the preterm newborn may be complicated by pulmonary hypertension (Walther et al., 1992). In several newborn animal models pulmonary hypertension is reversed by inhaled exogenous nitric oxide (Frostell et al., 1991; Roberts et al., 1993). If iNO therapy leads to a decrease in the need for ventilator support, it is possible that a reduction in lung injury may lead to preventing or ameliorating BPD.

Participants

Preterm newborn infants (<35 weeks gestation) with respiratory insufficiency despite assisted ventilation during the first 72 hours of life.

Intervention

Administration of iNO gas in addition to routine conventional support.

Comparison

Control (with or without placebo) and routine conventional support.

Outcome(s)

• Death prior to hospital discharge • Bronchopulmonary dysplasia (oxygen dependence at 36 weeks postmenstrual age) • Death or bronchopulmonary dysplasia (at 36 weeks postmenstrual age) • Intraventricular hemorrhage [any grade and more severe, grades 3 and 4] • Periventricular leukomalacia • Neurodevelopmental disability, i.e. survivors with neurological abnormality sufficient to affect quality of life, or developmental index more than two Standard Deviations below the mean, using validated scale at greater than 12 months of age; or mean developmental index among survivors at greater than 12 months of age • Oxygenation within 2 h of therapy • Retinopathy of prematurity (any stage and stage 3 and greater)

Studies

Randomized or quasi-randomized controlled trials.

Study description and setting

Seven randomized controlled trials of inhaled nitric oxide therapy in preterm infants with entry in the first three days of life based on oxygenation criteria were identified in the review of Barrington and Finer (Barrington 2007).

Results

Trials of early rescue treatment of infants based on oxygenation criteria demonstrated no significant effect of iNO on mortality or BPD (typical RR 0.95, 95% CI 0.88, 1.02; 6 studies, 864 infants). Studies of early rescue treatment with iNO demonstrated a trend toward increased risk of severe IVH (typical RR 1.27, 5%, CI 0.99, 1.62; 5 studies, 708 infants).

Confidence in results

High quality evidence for all primary outcomes reported.