Conditions: Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) Bronchopulmonary Dysplasia
Keywords: nitric oxide surfactant bronchopulmonary dysplasia prematurity neonates iNO Infasurf lung function ventilated infants
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 85
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.

Detailed description:
Surfactant dysfunction may contribute to the development of bronchopulmonary dysplasia (BPD) in persistently ventilated preterm infants. The investigators conducted a multi-center, randomized, blinded pilot study to assess the safety and efficacy of late administration of surfactant (Calfactant - high in protein B) in combination with prolonged inhaled nitric oxide in preterm infants \< 1000 grams birthweight (BW). Calfactant is one of several types of exogenous surfactant. Calfactant has the highest % of surfactant protein B of the different types.

Arms:
arm 1: Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated. arm 2: Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.

Interventions: intervention 1: Infasurf (ONY Inc.) intervention 2: Sham
Intervention descriptions: intervention 1: Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated. intervention 2: Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.

Protocol document: