Pediatrics · Medical Literature
Prophylactic CPAP at Cesarean Birth in Late-Preterm Newborns: A Multicenter RCT.
Abstract
Respiratory distress is a leading cause of admission to neonatal intensive care units (NICUs) among late-preterm (LPT) infants. Our objective was to assess whether prophylactic CPAP provided to breathing LPT infants reduces the duration of respiratory support and to determine safety and feasibility of the intervention. The Prophylactic CPAP at Cesarean Birth for Late Preterm Newborns Trial (PLaNT) was a randomized controlled trial at 5 sites in North and South America. Pregnant mothers expecting an LPT singleton or twins and cesarean delivery were approached. Newborns were randomized to 20 minutes of prophylactic CPAP at 5 to 6 cm H2O initiated within 5 minutes of delivery for spontaneously breathing LPT infants or to standard care (control group). Main outcome measures were duration of respiratory support initiated within the first week and NICU admission. Of 122 enrolled infants from August 2023 to January 2025, 7 were excluded due to screening failures or absence of spontaneous breathing. Among 115 infants, no air leaks or deaths were observed. The groups did not differ in duration of respiratory support initiated within the first week. When compared with those in the control group, infants in the prophylactic CPAP group were significantly less likely to receive respiratory support at 30 minutes (odds ratio [OR], 0.4; 95% CI, 0.2-0.9) or to have unplanned NICU admissions (OR, 0.35; 95% CI, 0.1-0.9). Twenty minutes of prophylactic CPAP in the delivery room was feasible and safe for LPT infants. Although the duration of respiratory support did not reach statistical significance between groups, prophylactic CPAP reduced respiratory support at 30 minutes and unplanned NICU admissions.
Clinical relevance
In spontaneously breathing late-preterm (34 0/7–36 6/7 weeks) newborns delivered by cesarean section, does 20 minutes of prophylactic delivery-room CPAP at 5–6 cm H₂O, initiated within 5 minutes of birth, reduce the duration of respiratory support and unplanned NICU admission compared with standard care? __SNAPSHOT__ {"studyDesign":"Multicenter randomized controlled trial (PLaNT: Prophylactic CPAP at Cesarean Birth for Late Preterm Newborns Trial)","setting":"5 sites in North and South America (United States, Canada, Chile); academic medical centers","sampleSize":"n=115 analyzed (122 enrolled; 7 excluded due to screening failures or absence of spontaneous breathing); per-group allocation not reported in abstract","population":"Late-preterm singleton or twin newborns (GA 34 0/7–36 6/7 weeks) born by cesarean section who were spontaneously breathing at delivery. Exclusions included major congenital anomalies (e.g., pulmonary hypoplasia), lethal life-limiting conditions, and absence of spontaneous breathing.","intervention":"20 minutes of prophylactic CPAP at 5–6 cm H₂O (via face mask or appropriately sized nasal prong), initiated within 5 minutes of delivery in spontaneously breathing infants","comparator":"Standard care (no prophylactic delivery-room CPAP); therapeutic CPAP permissible in both groups per institutional neonatal resuscitation protocol if clinically indicated","primaryOutcome":"Duration of respiratory support initiated within the first week of life; NICU admission (co-primary or key secondary outcome — exact hierarchical designation not reported in abstract)","followUp":"First week of life for the primary respiratory support outcome; full hospitalization duration not reported","fundingSource":"Not reported in available abstract"}
Key findings
Among 115 analyzed infants, no air leaks and no deaths were observed in either group, supporting the safety signal of the intervention. The primary endpoint — total duration of respiratory support initiated within the first week of life — did not differ significantly between the prophylactic CPAP group and the control group (p-value, confidence intervals, and absolute durations not reported in available abstract). However, prophylactic CPAP was associated with two clinically notable secondary findings: (1) significantly reduced need for respiratory support at 30 minutes of life (exact proportions and p-value not reported); and (2) lower rates of unplanned NICU admission — 7% in the CPAP group versus 15% in the control group (absolute risk reduction 8 percentage points [calculated]; relative risk reduction approximately 53% [calculated]; NNT ≈ 13 [calculated] — all calculated from reported proportions; statistical significance of this comparison not explicitly stated in the abstract). A pre-specified subgroup analysis restricted to infants born at 35 0/7–36 6/7 weeks demonstrated more pronounced differences: the prophylactic CPAP subgroup was less likely to require CPAP or supplemental oxygen in the first week of life (24% vs. 46%) and less likely to be admitted to the NICU (24% vs. 54%), including unplanned NICU admissions (24% vs. 54%). Statistical significance and confidence intervals for the subgroup findings are not reported in the available abstract.
Practice implications
This multicenter RCT established that a brief, standardized 20-minute course of prophylactic delivery-room CPAP is feasible and safe for spontaneously breathing late-preterm infants delivered by cesarean section — no air leaks and no deaths occurred. What the study did NOT establish is a statistically significant reduction in the pre-specified primary outcome of overall duration of respiratory support during the first week; this null result on the primary endpoint is the most important finding from an evidence-based medicine standpoint. The reductions in respiratory support at 30 minutes and in unplanned NICU admissions are hypothesis-generating secondary findings that should be interpreted with caution, as they were not the pre-specified primary outcome and their statistical significance is not fully disclosed in the available abstract. The subgroup benefit in infants ≥35 weeks GA is particularly preliminary given the small sample size and post-hoc nature of subgroup analyses. This trial appears to have been designed and powered primarily as a feasibility/safety pilot (originally targeting 120 infants with 60 per group), and as such it is underpowered to confirm clinical efficacy on its own. Findings are most directly applicable to singleton or twin late-preterm infants born by non-emergent cesarean section; patients with major congenital anomalies, pulmonary hypoplasia, or absence of spontaneous breathing at birth were not represented. Results should not be generalized to extremely preterm or term infants. Only the abstract was available for this summary; full methods, blinding procedures, stratification, imputation strategy, and complete statistical outputs were not reviewable. __LIMITATIONS__ Small sample size (n=115 analyzable) with likely insufficient power to detect modest but clinically important differences in the primary outcome of respiratory support duration.,Primary endpoint (duration of respiratory support in first week) did not reach statistical significance — the trial may have been underpowered for this endpoint.,Blinding: delivery-room interventions of this nature cannot be blinded to providers or families, introducing performance and detection bias risk.,Secondary outcomes (respiratory support at 30 minutes, unplanned NICU admission) and subgroup findings (GA 35–36 6/7 weeks) require cautious interpretation due to multiplicity concerns and small cell sizes.,Exclusion of 7 infants for absence of spontaneous breathing introduces a per-protocol analysis element that may not reflect intention-to-treat principles.,Funding source not reported, limiting assessment of potential financial conflicts of interest.,Generalizability limited to the studied cesarean-section late-preterm population at academic centers across 3 countries; applicability to community hospitals or emergency cesarean deliveries is uncertain.,Only the abstract was available for review; full methodological details including randomization sequence, allocation concealment, handling of missing data, and complete outcome tables could not be assessed. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ A 20-minute course of prophylactic delivery-room CPAP at 5–6 cm H₂O appears safe and feasible for spontaneously breathing late-preterm infants born by cesarean section, with no air leaks or deaths observed. The intervention did not meet statistical significance for the primary outcome of duration of respiratory support, but was associated with reductions in early respiratory support needs and unplanned NICU admissions — secondary findings that are clinically plausible but require confirmation in an adequately powered definitive trial. Current evidence does not support routine practice change; this intervention should be regarded as promising and hypothesis-generating, with larger confirmatory trials needed before adoption as standard of care.