Indiana University
The PLaNT 2 study will test whether giving breathing support soon after birth can help late preterm babies born by cesarean section (C-section). The goal is to lower breathing problems and the need for admission to the neonatal intensive care unit (NICU). Late preterm babies are born a few weeks before their due date. They have a higher risk of breathing problems after birth, especially after a C-section. A recent international pilot study showed promising results with early breathing support in these babies. A larger study is now needed to find out if this approach works. Continuous positive airway pressure (CPAP) is a common form of breathing support for newborns. It provides gentle air pressure through a mask or nasal prongs. CPAP is usually given after a baby develops breathing problems. PLaNT 2 will test giving CPAP shortly after birth, before breathing problems develop. The study will include 300 babies born by C-section at 35 to 36 weeks of pregnancy. Babies who are breathing on their own within 5 minutes after birth may take part. The study will randomly assign babies to one of two groups: * One group will receive 20 minutes of CPAP shortly after birth. * The other group will receive the hospital's usual care. Babies in either group can receive CPAP or other breathing support later if they need it. The main question is whether early CPAP lowers the number of babies admitted to the NICU for breathing support. Researchers will also look at the need for breathing support after birth. They will study parental stress, bonding between mothers and babies, and exclusive breastfeeding. If this approach works, it could lower breathing problems and unnecessary NICU admissions. This could allow more babies to stay with their families. CPAP is already available in many hospitals, so this approach could be used in different health care settings around the world. It may also support early bonding, breastfeeding, and family-centered newborn care.
Late preterm infants are at increased risk of respiratory morbidity during the transition from fetal to newborn life. This risk is particularly important among infants born by cesarean section. These infants do not experience some of the physiologic changes associated with labor and vaginal delivery that promote lung fluid clearance and adaptation to air breathing. As a result, respiratory distress is a common reason for neonatal intensive care unit (NICU) admission in this population. NICU admission may be necessary when an infant requires respiratory support or other intensive care. However…
Inclusion Criteria: * Inborn newborns delivered by cesarean section (with or without labor) * Gestational age 35⁰⁄₇ to 36⁶⁄₇ weeks by best obstetrical estimate * Spontaneously breathing within 5 minutes after birth. Exclusion Criteria: * Major congenital anomalies
Participants assigned to this arm will receive 20 minutes of prophylactic continuous positive airway pressure (CPAP) at 5 to 6 cm H2O, started within 5 minutes after birth. CPAP may be provided at the radiant warmer or while the infant is on the mother's chest. Participants may receive additional CPAP or other respiratory support if clinically needed.
Participants will receive standard care after birth without prophylactic CPAP. CPAP or other respiratory support may be provided if clinically needed according to usual clinical care