1st Patients recruited for Prophylactic DR-CPAP on Late Preterm Infants Born by C-section: an RCT (PLANT)

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