PHILODENDROOM tested 5 vs 8 cmH₂O—but the pilot cannot choose a starting CPAP
At 15 minutes, SpO₂/FiO₂ ratios were 271 versus 269 and PPV was 10/28 in both arms; pneumothorax occurred in 0/28 versus 3/28. PHILODENDROOM establishes that 5-versus-8 cmH₂O randomization is feasible—not which starting pressure is better.
THE HOT TAKE
PHILODENDROOM answers a methods question more convincingly than a treatment question. In 56 infants born at 26+0 to 29+6 weeks, randomizing the first 15 minutes of delivery-room CPAP to 5 or 8 cmH₂O was feasible. It did not establish that either pressure produced better oxygenation, less ventilation, or safer care.
Feasible is not the same as better. This pilot did not clear the evidentiary bar for declaring a superior starting CPAP pressure.
WHAT WAS RANDOMIZED
At one level III NICU in Milan, infants requiring non-invasive support immediately after birth were allocated 1:1 by a computer-generated sequence and opaque envelopes. Twenty-eight received 5 cmH₂O and 28 received 8 cmH₂O through a face mask and T-piece, with initial FiO₂ 0.30 and gas flow 10 L/min. After 15 minutes, both groups moved to 6 cmH₂O until NICU entry. All 56 received their allocation, with no crossover, protocol deviation, loss to follow-up, or missing outcome data.
| Element | What the study did |
|---|---|
| Setting | Single tertiary NICU in Milan; recruitment April 2020 to November 2023 |
| Eligibility | 26+0 to 29+6 weeks and requiring non-invasive respiratory support immediately after birth |
| Randomization | 28 infants to 5 cmH₂O; 28 infants to 8 cmH₂O; intention-to-treat |
| Exposure | Assigned pressure for 15 minutes, then 6 cmH₂O in both arms |
| Primary claim | Feasibility of a future multicenter comparison; efficacy outcomes were exploratory |
THE PATIENT-LEVEL NUMBERS
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