Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants

• Status: Terminated
• Trial end date: 2002-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: Beractant; Pulmonary Surfactants

Criteria

Inclusion Criteria:

• Infants born at 1,250-2g000 grams birth weight

• <12 hours of age

• Clinical and radiographic diagnosis of respiratory distress syndrome (RDS)

• Receiving supplemental oxygen with head-hood Fi02 of 0.35 to 0.50 or CPAP Fi02 of 0.25 to 0.50 to maintain oxygen saturation less than 90 percent and more than 96 percent

Exclusion Criteria:

• Receiving mechanical ventilation

• Air leak

• Pulmonary hemorrhage

• Major congenital anomaly

• Congenital non-bacterial infection

• Parental refusal of consent

• Refusal of attending neonatologist