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.
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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.
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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)
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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
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Efficacy Endpoints
Primary:
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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:
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Proportion of newborns who are hypothermic
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Proportion of newborns who are hypoglycemic
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Apgar score
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Rates of NICU admissions
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Pulmonary air-leak syndromes
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Surfactant use
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Neonatal encephalopathy
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Neonatal mortality
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Rate of intracranial hemorrhage
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Sepsis
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Necrotizing enterocolitis
Safety Evaluations
Adverse events
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Statistical Methodology
The final analysis will be conducted after the study is completed using intention to treat approach.
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Clinical Centers
USA, Canada, Chile
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Enrolment Period: 2 years
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ClinicalTrials.Gov Trial: NCT05204719
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