Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether additional surfactant(Infasurf) doses at 7 to 10 days of life time will improve lung function in premature infants, allowing a decrease in required oxygen concentration and ventilator settings.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborators: University of Pennsylvania; Women & Children's Hospital of Buffalo
• Treatments: Calfactant; Pulmonary Surfactants

Criteria

Inclusion Criteria:

• Less than 1250 gm birthweight

• Day 5-21 of life

• Intubated and mechanically ventilated, with respiratory decompensation, defined as the majority of daily severity scores (calculated every 6 hr from average of respiratory settings over 3-4 hour period) rising from baseline < 1.8, to > 3.5, sustained for >24hr. Note: Prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.

Exclusion Criteria:

• Serious congenital malformations

• Life expectancy < 7 days from enrollment

• Patent ductus arteriosus at time of decompensation

• Pulmonary hemorrhage as cause of respiratory decompensation

• Active air leak syndrome at time of decompensation

• Postnatal steroid therapy for lung disease