The PLaNT-Trial: Prophylactic CPAP to Optimize Outcomes in Spontaneously Breathing Late Preterm Infant Born by C-Section
Population
Preterm infants between 34+0 to 36+6 weeks gestation born through a non-emergent C-Section.
Primary Objective
Evaluate the feasibility of performing a multicenter RCT comparing the use of early prophylactic CPAP versus no CPAP among late preterm newborn infants born by scheduled cesarean deliveries.
Design and Sample Size
Prospective multi-centre randomized controlled trial (RCT) with either CPAP+routine care or routine care only. 120 infants total (60 per group)
Inclusion Criteria
Preterm infants between 34+0 to 36+6 weeks gestation born through a non-emergent C-Section.
Exclusion Criteria
Fetal anomalies or death, pulmonary hypoplasia, comfort care, and provider perceived contraindications to CPAP
Efficacy Endpoints
Primary:
-
The main outcome measures will be the receipt of respiratory support (maximal) and duration of respiratory support throughout hospitalization including, but not limited to, supplemental oxygen and mechanical ventilation.
Secondary:
-
Proportion of newborns who are hypothermic
-
Proportion of newborns who are hypoglycemic
-
Apgar score
-
Rates of NICU admissions
-
Pulmonary air-leak syndromes
-
Surfactant use
-
Neonatal encephalopathy
-
Neonatal mortality
-
Rate of intracranial hemorrhage
-
Sepsis
-
Necrotizing enterocolitis
Safety Evaluations
Adverse events
Statistical Methodology
The final analysis will be conducted after the study is completed using intention to treat approach.
Clinical Centers
USA, Canada, Chile
Enrolment Period: 2 years
ClinicalTrials.Gov Trial: NCT05204719