Very Early Surfactant and NCPAP for Premature Infants With RDS

PHASE3CompletedINTERVENTIONAL
Enrollment

278

Participants

Timeline

Start Date

January 31, 2004

Study Completion Date

December 31, 2006

Conditions
Respiratory Distress SyndromePneumothorax/Pulmonary Intersticial EmphysemaChronic Lung Disease
Interventions
OTHER

Very early surfactant and bubble NCPAP

For patients randomized to early NCPAP plus surfactant, 4ml/kg of surfactant were administered through an endotracheal tube in two aliquots, 2 minutes apart followed by positive pressure ventilation administered for one minute with a Neopuff Infant Resuscitator pre-set to give a peak pressure of 20 cm H2O and 5 cm H2O of positive end expiratory pressure. Infant was then extubated and placed on NCPAP of 6 cmH2O

OTHER

bubble NCPAP

"Premature infants randomized to bubble NCPAP alone will continue on NCPAP until they reach yes or no treatment failure criteria."

Trial Locations (1)

Unknown

Department of Epidemiology and Biostatistics Pontificia Universidad Javeriana, Bogota

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pontificia Universidad Javeriana

OTHER

collaborator

Vanderbilt University School of Medicine

OTHER

collaborator

Abbott

INDUSTRY

collaborator

Fisher and Paykel Healthcare

INDUSTRY

lead

Colombian Neonatal Research Network

OTHER