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Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants
Not Recruiting
Trial ID: NCT00005774
Purpose
Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is
associated with lung injury and nosocomial infection. Moderately premature infants with mild
respiratory distress do not routinely receive artificial surfactant early in their course of
treatment. This multi-center, randomized trial tested whether early surfactant therapy and
nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced
mechanical ventilation usage without added complications. Infants with mild to moderate
respiratory distress syndrome were enrolled in the trial and given either early
administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or
standard practice (surfactant according to current center practice, only after initiation of
mechanical ventilation), to see whether the experimental method would reduce the need for
subsequent mechanical ventilation.
Official Title
Early Surfactant Followed by Nasal CPAP to Reduce the Use of Mechanical Ventilation Without Additional Morbidity in Infants 1250- 2000 Grams With RDS
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Infants born at 1,250-2g000 grams birth weight
- <12 hours of age
- Clinical and radiographic diagnosis of respiratory distress syndrome (RDS)
- Receiving supplemental oxygen with head-hood Fi02 of 0.35 to 0.50 or CPAP Fi02 of 0.25
to 0.50 to maintain oxygen saturation less than 90 percent and more than 96 percent
Exclusion Criteria:
- Receiving mechanical ventilation
- Air leak
- Pulmonary hemorrhage
- Major congenital anomaly
- Congenital non-bacterial infection
- Parental refusal of consent
- Refusal of attending neonatologist
Intervention(s):
drug: Early surfactant
drug: Standard practice
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305