Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration
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).
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Meconium Aspiration Syndrome
Intervention
Bovine Lipid Extract Surfactant (administered by lavage), Bovine Lipid Extract Surfactant (administered by bolus)
Location
The Hospital for Sick Children
Toronto
Ontario
Canada
M5G 1X8
Status
Recruiting
Source
The Hospital for Sick Children
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00312507
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Leukemia Virus, Bovine
The type species of DELTARETROVIRUS that causes a form of bovine lymphosarcoma (ENZOOTIC BOVINE LEUKOSIS) or persistent lymphocytosis.
Lipidoses
Conditions characterized by abnormal lipid deposition due to disturbance in lipid metabolism, such as hereditary diseases involving lysosomal enzymes required for lipid breakdown. They are classified either by the enzyme defect or by the type of lipid involved.
Immunodeficiency Virus, Bovine
The type species of LENTIVIRUS, subgenus bovine lentiviruses (LENTIVIRUSES, BOVINE), found in cattle and causing lymphadenopathy, LYMPHOCYTOSIS, central nervous system lesions, progressive weakness, and emaciation. It has immunological cross-reactivity with other lentiviruses including HIV.
Diarrhea Virus 2, Bovine Viral
A species of PESTIVIRUS causing systemic infections including BOVINE VIRUS DIARRHEA-MUCOSAL DISEASE and BOVINE HEMORRHAGIC SYNDROME in cattle and some other cloven-hoofed animals. There are several strains and two biotypes: cytopathic (rare) and non-cytopathic. The severity of disease appears to be strain dependent. Cytopathogenic effects do not correlate with virulence as non-cytopathic BVDV-2 is associated only with Hemorrhagic Disease, Bovine.
Enzootic Bovine Leukosis
A lymphoid neoplastic disease in cattle caused by the bovine leukemia virus. Enzootic bovine leukosis may take the form of lymphosarcoma, malignant lymphoma, or leukemia but the presence of malignant cells in the blood is not a consistent finding.
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