Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates.

The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alan Fujii
• Collaborator: Dey LP
• Treatments: Beractant; Poractant alfa; Pulmonary Surfactants

Criteria

Inclusion Criteria:

• <29 6/7 and >24 0/7 weeks gestational age

• Inborn at the participating institution enrolling the patient

• FIO2 >25% and Intubated with mean airway pressure > 5 cm H20

• <8 hours age at randomization

• Signed informed consent from parent(s)

Exclusion Criteria:

• <500 g birth weight

• <24 0/7 weeks gestational age (best estimate)

• Prolonged Premature Rupture of membranes >3 weeks (21 days)

• Apgar score < 3 at 5 minutes

• Impending death anticipated within the first 3 days of life, moribund

• Severe congenital anomalies