Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A research study that will evaluate if giving surfactant medication to premature babies weighing < 1250 gm at birth during the second and third weeks of life will help their lungs. We are enrolling those premature babies who continue to require the breathing tube and the mechanical ventilator at days 7-10 of life.

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

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborators: Alta Bates Summit Medical Center; Children's Hospital & Research Center Oakland; Children's Mercy Hospital Kansas City; Long Island Jewish Medical Center; St. Louis Children's Hospital; UCSF Benioff Children's Hospital Oakland; University of Pennsylvania; Women & Children's Hospital of Buffalo
• Treatments: Calfactant; Pulmonary Surfactants

Criteria

Inclusion Criteria:

• Less than or equal to1250 gm birthweight

• Day 7-10 of life

• Intubated and mechanically ventilated at day 7-10 of life

Exclusion Criteria:

• Infants intubated solely for apnea

• Serious congenital malformations

• Life expectancy < 7 days from enrollment

• Pulmonary hemorrhage at time of enrollment

• Active air leak syndrome at time of enrollment

• Bilateral grade IV intracranial hemorrhage

• Postnatal systemic steroid therapy for lung disease

Note: Prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.