The purpose of this research is to learn new information that may help other infants that have respiratory distress syndrome and need breathing support after birth. The goal of this research is to see if continuous positive airway pressure (CPAP) alone or CPAP with surfactant administration through a less invasive method via an Airway Device (supraglottic airway device) temporarily placed above the vocal cords is better for treating respiratory distress syndrome in late preterm and early term infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
422
A single dose of surfactant will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). A supraglottic airway device will be used as a standardized procedure for surfactant administration via SALSA using an AirLife Air-Q.
Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP).
Sharp Chula Vista Medical Center
Chula Vista, California, United States
Sharp Grossmont Hospital
La Mesa, California, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
Difference in Ranked Composite of Morbidities
Determine if there is a difference in ranked composite of morbidities including death, development of pneumothorax/ pulmonary air leaks, Respiratory Severity Score (RSS), time to initial feeding, and LOS (length of hospital stay) between the treatment and control groups using a linked count of participants who fall within each prespecified rank.
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
Length of Hospital Stay
Length of hospital stay (LOS), days.
Time frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.
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