Thrasher Research Fund - Medical research grants to improve the lives of children

Project Details

E.W. "Al" Thrasher

Status: Funded - Open

Prophylactic CPAP for Late Preterm Infants Born by C-Section to Reduce NICU Admission: A Multicenter Randomized Controlled Trial (PLaNT 2 study)

Edgardo Szyld, MD, MSc

Summary

BACKGROUND: Late preterm infants are at increased risk of respiratory distress and NICU admission, particularly after cesarean delivery. Our recently published international pilot randomized trial showed promising results suggesting that 20 minutes of prophylactic CPAP immediately after birth may reduce respiratory complications and NICU admissions in this population. GAP: Although continuous positive airway pressure (CPAP) is routinely used to treat respiratory distress after it develops, evidence is limited on whether brief prophylactic CPAP immediately after birth can prevent respiratory deterioration and reduce NICU admission in this population. HYPOTHESIS: We hypothesize that 20 minutes of prophylactic CPAP, initiated within 5 minutes of birth, will reduce NICU admission for respiratory support compared with standard care in spontaneously breathing infants born by cesarean section at 35 to 36 weeks gestation. METHODS: PLaNT 2 is a pragmatic, multicenter, international randomized controlled trial enrolling 300 infants. Participants will be randomized 1:1 to prophylactic CPAP at 5 to 6 cm H2O for 20 minutes or standard care, with clinically indicated rescue respiratory support available in either group. The primary outcome is NICU admission for respiratory support; secondary outcomes include respiratory support needs, parental stress, mother-infant bonding, and exclusive breastfeeding. RESULTS: Pending. IMPACT: If effective, prophylactic CPAP could reduce respiratory complications and unnecessary NICU admissions, allowing more newborns to remain with their families. Because CPAP is already widely available, this approach could be implemented quickly across diverse healthcare settings worldwide while supporting early bonding, breastfeeding, and family-centered newborn care.

Supervising Institution:
Indiana University

Project Location:
Canada, Chile, Spain, United Kingdom, United States

Award Amount:
$549,067