To compare the efficacy and safety of nasal continuous positive airway pressure (NCPAP) versus nasal intermittent positive pressure ventilation (NIPPV) as primary respiratory support prior to minimally invasive surfactant administration (MISA) in preterm infants (24-29+6 weeks’ gestation).
Approach:
Trial Design: A multicenter noninferiority randomized clinical trial was conducted across 11 tertiary neonatal intensive care units (NICUs) in China.
Participants: Eligible infants were those with gestational age 24 to 29+6 weeks, requiring noninvasive respiratory support for respiratory distress and diagnosed with RDS within 2 hours after birth.
Randomization: Infants were randomly assigned 1:1 to NCPAP or NIPPV, stratified by clinical center, gestational age, birth weight, sex, and maternal corticosteroid exposure.
Treatment Protocol: NCPAP provided continuous pressure via nasal prongs, while NIPPV delivered synchronized ventilation with peak inspiratory pressures.
Surfactant Administration: Calf pulmonary surfactant was administered via MISA within 120 minutes after birth to infants with RDS.
Key Findings:
The trial was halted prematurely after enrolling 312 infants due to conclusive NCPAP inferiority.
NIPPV showed potential benefits in reducing treatment failure but was associated with increased risks of abdominal distention and gastrointestinal issues.
Meta-analyses indicated NIPPV's efficacy in reducing reintubation rates compared to NCPAP.
Interpretation:
The study highlights the need for further evaluation of NIPPV as primary support in extremely preterm infants, given the inconclusive evidence regarding its superiority over NCPAP.
Limitations:
The trial was stopped early, limiting the sample size and power to detect differences.
The subgroup analysis for infants less than 30 weeks’ gestation did not show significant IMV reduction.
Conclusion:
Further research is required to establish the safety and efficacy of NIPPV compared to NCPAP in the highest-risk preterm population.
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