Clinical Trial: Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration
Brief 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 Summary:
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.
Sponsor: The Hospital for Sick Children
Current Primary Outcome:
- % change in oxygenation indices from baseline to 1 and 6 h following treatment
- % change in dynamic pulmonary compliance from baseline to 1 and 6 h following treatment
- % change in pulmonary artery pressure from baseline to 1 and 6 h following treatment
- measures of efficacy of ventilation and oxygenation at 1 h and 6 h following treatment
- cardiac function by echocardiography at 6 hours following treatment
Original Primary Outcome: Same as current
Current Secondary Outcome:
- % change in oxygenation indices, dynamic pulmonary compliance and pulmonary vascular resistance from baseline to 12, 24 and 48 h following treatment
- measures of efficiency of ventilation and oxygenation at 12, 24 and 48 h following treatment
- duration of mechanical ventilation, defined as the cumulative time of mechanical ventilation
- length of time on CPAP
- length of time with oxygen supplementation
- length of time on inotropes and maximum inotropic score.
- need for and length of use of NO
- need for and length of use of ECMO
- time to full enteral feeds
- attainment of exit criteria
- development of significant pulmonary hemorrhage
- development of significant intracranial hemorrhage
- development of tension pneumothorax requiring drainage
- need for repeat surfactant
- length of stay in a level III NICU
- mortality
Original Secondary Outcome: Same as current
Information By: The Hospital for Sick Children
Dates:
Date Received: April 6, 2006
Date Started: April 2006
Date Completion:
Last Updated: October 16, 2006
Last Verified: October 2006
