NCT00312507

Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 1 Hour – 24 Hours
• Healthy volunteers: Not accepted

Summary

The objective of this pilot study is to examine the feasibility and safety of performing a larger trial to assess outcomes following treatment of meconium aspiration syndrome with surfactant lavage compared to bolus surfactant. Specifically, we will determine if surfactant lavage results in a more rapid improvement in physiologic outcomes (e.g. pulmonary compliance), as well as clinical outcomes (e.g. length of time on mechanical ventilation).

Detailed description

Meconium-stained amniotic fluid occurs in about 5 to 20% of all births in the United States, with meconium aspiration syndrome occuring in approximately 5% of these infants. In this disease process, meconium is believed to mechanically obstruct the airways, causing a chemical pneumonitis and inactivate surfactant. Approximately one-third of these babies need mechanical ventilation and approximately 5% die. Since 1990 surfactant has been the standard of care for treatment of respiratory distress syndrome. Pulmonary compliance and gas exchange often improve rapidly after administration of surfactant. Its use has led to significantly reduced mortality rates and improved short-term respiratory function. There is evidence to support its use in other neonatal respiratory disorders where there is dysfunction or inactivation of surfactant. Its use in meconium aspiration syndrome is the most well-studied alternate use to date. The Canadian Pediatric Society's (2005) position statement recommends that infants with meconium aspiration syndrome who are intubated and require more than 50% oxygen should receive exogenous surfactant therapy. Studies in both animals and humans suggest that surfactant helps in meconium aspiration, either administered as a bolus or as a lavage. There have been no trials to date comparing the efficacy of surfactant lavage to bolus surfactant in human neonates with meconium aspiration or examining the physiologic effects of surfactant, given as either a bolus or lavage, in the treatment of meconium aspiration syndrome. This study will assess the relative efficacy of these two methods of administering surfactant and their effect on physiologic and clinical outcomes.

Conditions

• Meconium Aspiration Syndrome

Interventions

Type	Name	Description
DRUG	Bovine Lipid Extract Surfactant (administered by lavage)
DRUG	Bovine Lipid Extract Surfactant (administered by bolus)

Timeline

• Start date: 2006-04-01
• First posted: 2006-04-10
• Last updated: 2006-10-17

Locations

1 site across 1 country: Canada