1,160
Participants
Start Date
April 1, 2021
Primary Completion Date
September 5, 2024
Study Completion Date
December 17, 2026
budesonide (Pulmicort nebulizing suspension).
The first dose of budesonide is 0.25 mg/kg in a volume of 1 ml/kg, for a total volume of 2.5 ml/kg of Curosurf + 1 ml/kg of budesonide. If the infant is to receive a second dose of study drug within 50 hours of birth, the dosage of Curosurf is 1.25 ml/kg for the second dose and 1 ml/kg of budesonide.
surfactant (poractant alfa;Curosurf)
The first dose of surfactant (poractant alfa; Curosurf) is 2.5 ml/kg. If the infant is to receive a second dose of study drug within 50 hours of birth, the dosage of Curosurf is 1.25 ml/kg for the second dose.
University of Rochester, Rochester
University of Pennsylvania, Philadelphia
RTI International, Durham
Duke University, Durham
Emory University, Atlanta
University of Mississippi Medical Center - Children's of Mississippi, Jackson
Research Institute at Nationwide Children's Hospital, Columbus
Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland
Cincinnati Children's Medical Center, Cincinnati
University of Iowa, Iowa City
Northwestern Lurie Children's Hospital of Chicago, Chicago
University of Texas Southwestern Medical Center at Dallas, Dallas
University of Texas Health Science Center at Houston, Houston
University of Utah, Salt Lake City
University of New Mexico, Albuquerque
Sharp Mary Birch Hospital for Women & Newborns, San Diego
Stanford University, Palo Alto
University of Alabama, Birmingham
Brown University - Women and Infants Hospital of Rhode Island, Providence
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
NICHD Neonatal Research Network
NETWORK