Meconium Aspiration Syndrome Clinical Trial
Official title:
Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration
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).
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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