NCT00165074

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 7 Days – 10 Days
• Healthy volunteers: Not accepted

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.

Detailed description

Pulmonary surfactant is required for normal lung function. Preliminary data from previous trials suggest that more than half of chronically ventilated premature infants, greater than 1 week of age, have at least one episode of surfactant dysfunction, as measured in vitro, associated with a low surfactant protein B content. We propose to enroll premature infants less than 1250 gm birthweight, between days 5 and 21 of life who are intubated, mechanically ventilated, with a respiratory decompensation, defined as a severity score (mean airway pressure x FIO2) rising from a baseline of \< 1.8 to \> 3.5, sustained for \> 24 hours. Infants will receive two doses of Infasurf surfactant, 12-24 hours apart, at the standard dose of 3 ml/kg. Primary outcome is the change in respiratory severity score at 72 hours post surfactant treatment compared to pre-treatment. Sample size is 31 infants, study duration is 3 years, and recruitment of study patients will occur at the Hospital of the University of Pennsylvania, and Women and Children's Hospital of Buffalo.

Conditions

• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Infasurf (drug)	Infasurf 3 cc/kg instilled via endotracheal tube q 12-24 hours x 2 doses

Timeline

• Start date: 2003-06-01
• Completion: 2007-06-01
• First posted: 2005-09-14
• Last updated: 2007-11-22