How Much Breathing Support Should a Tiny Lung Get in the First Minutes of Life?

What a Small Italian Trial Learned About the Starting Pressure of Breathing Support Right After a Very Premature Birth

When a baby is born many weeks too soon, doctors help its fragile lungs take their first breaths with a gentle nasal air-pressure device called CPAP. A new Italian pilot trial, nicknamed PHILODENDROOM, compared two starting pressures of that support and found the comparison can be studied safely, with early signals worth knowing even though the trial was too small to settle the question [1].

A Problem That Has Outlived Every Generation of Treatment

Helping a premature baby breathe has been one of newborn medicine's central challenges for well over a century. More than seventy years ago, doctors first carefully described what happens inside the lungs of babies who die from severe breathing difficulty after being born too early — a condition once called hyaline membrane disease, now understood as respiratory distress syndrome, caused by immature lungs that lack a slippery soap-like substance called surfactant that keeps the tiny air sacs from collapsing between breaths [2]. For a long time, the only real treatment available once a baby's breathing failed was a breathing tube connected to a machine that breathed for the baby entirely. That approach saved many lives, but doctors gradually learned that pushing air into fragile premature lungs too forcefully, for too long, could itself cause lasting lung damage — bruising and scarring the very tissue it was meant to protect.

Over the following decades, a large body of careful research — including a landmark review pooling the results of many studies — showed that when possible, keeping a premature baby breathing on their own with gentle CPAP support, rather than immediately placing a breathing tube, lowers the risk of death and of the chronic lung disease of prematurity called bronchopulmonary dysplasia [3]. CPAP has therefore become the preferred first step almost everywhere very premature babies are born. What nobody had ever tested directly, though, is exactly how much pressure that first puff of CPAP support should carry. International guidelines suggest starting somewhere in a range — roughly what doctors measure as 5 to 6 units of pressure — but that range has always come from experience and expert consensus rather than from a trial that actually compared different starting pressures against each other [4]. Careful animal research had already hinted at why the details might matter: gently and gradually filling a premature lung with air, rather than forcing it open all at once, causes noticeably less injury to delicate lung tissue [5].

What the PHILODENDROOM Trial Did

PHILODENDROOM (the nickname given to this pilot trial, which tested two starting pressures of CPAP support in the delivery room) was carried out at a single large children's hospital, the "V. Buzzi" Children's Hospital in Milan, Italy, between 2020 and 2023. The researchers enrolled 56 babies born very early — between about 26 and just under 30 weeks of pregnancy, roughly ten to fourteen weeks before a full-term due date — who needed breathing support right after birth. Using a coin-flip-like random assignment, half of these babies (28) were started on a lower CPAP pressure and half (28) were started on a higher one, for the first 15 minutes of life, after which every baby was moved to the same standard pressure [1]. Parents had agreed in advance to their baby being part of whichever group the random assignment chose, and the study was registered publicly and approved by a hospital ethics committee before it began.

Because this was what researchers call a "pilot" study — a smaller trial designed mainly to find out whether a bigger, more definitive trial is even possible — the main goal was not to prove which pressure is better. It was to prove the study itself could be done properly. On that goal, the trial succeeded completely: every single baby who was signed up finished the study, every family's choice was honoured with no mix-ups between groups, and there were no unexpected roadblocks, even though enrollment stretched across the disruptive early years of the COVID-19 pandemic.

What the Researchers Found

In terms of how well the babies' lungs were working fifteen minutes after birth, measured by how much extra oxygen they needed and how well that oxygen was getting into their blood, the two groups looked essentially the same — there was no meaningful difference at all. The same number of babies in each group needed a doctor to help them breathe with extra manual puffs of air. Very few babies in either group needed a full breathing tube placed in the delivery room, and that number, too, was similar between groups.

One interesting difference did emerge. Babies who started on the lower pressure reached the point where their care team decided they needed medicine called surfactant — the slippery substance their lungs were missing — a bit sooner on average (about two hours after birth) than babies who started on the higher pressure (about three and a half hours after birth). By the end, though, roughly the same number of babies in each group ended up needing surfactant regardless of which pressure they started with; the higher pressure seemed mainly to buy a little extra time before that decision point, not to prevent the need for surfactant altogether.

There was also a smaller, less certain signal worth mentioning honestly. A few more babies in the higher-pressure group experienced a small air leak from the lung — a known but uncommon complication of any breathing support, called a pneumothorax — than babies in the lower-pressure group (three babies compared with none). With a study this small, that difference could easily be due to chance rather than a real effect of the higher pressure, but it is exactly the kind of early warning sign that careful researchers watch closely in a larger follow-up study; separate research using bedside lung ultrasound has shown that the amount of pressure used really does change how a newborn lung fills with air, which may help explain why the two groups in this trial behaved a little differently [6]. Other researchers studying higher pressures in slightly older babies have raised a related, gentle word of caution — too much pressure can occasionally push air into the stomach or make it harder for blood to return to the heart — which is a reminder that "higher" is not automatically "better" [7]. The published report also mentioned a hopeful, though not statistically proven, trend toward babies in the higher-pressure group needing a breathing machine for less time overall and developing slightly less chronic lung disease, but the exact numbers behind that trend were not available in the parts of the study we could access, and we are saying so plainly rather than guessing.

What This Means for Families

If your baby is born very prematurely and needs breathing support in the delivery room, this study does not mean your hospital's usual approach is wrong, nor does it point to one "correct" pressure that every family should ask for. What it shows is that both a lower and a higher starting pressure appeared to be reasonably safe and effective for helping these tiny lungs take their first breaths, and that researchers are now able to study this question properly with real evidence instead of guesswork and tradition alone. The small hint of more air leaks with the higher pressure is a reason for continued caution and further study, not proof of harm. Every neonatal team already watches closely for exactly this kind of complication regardless of which pressure they use, adjusting support constantly based on how an individual baby is doing rather than following a fixed number rigidly.

Families should also take comfort in what this study demonstrates about how newborn intensive care research is conducted: with prior ethics review, with informed parental consent, and with careful, honest reporting of even inconclusive or uncertain results rather than only reporting encouraging ones.

What Researchers Are Working On Next

Because only 56 babies took part, this study cannot say with real confidence which starting pressure is genuinely better for outcomes that matter most in the long run, such as chronic lung disease or survival — it simply was not large enough to detect such differences reliably, and it was never designed to. The logical next step, which the same research team and others across Europe are already pursuing, is a much larger trial across many hospitals that can properly measure whether one starting pressure leads to better outcomes overall — one similarly designed European trial testing a related breathing-support strategy in the delivery room has already shown that this kind of research is achievable and worth pursuing further [8]. Other researchers are exploring whether the best approach might not be a single fixed pressure at all, but rather adjusting the pressure continuously based on how hard each individual baby is working to breathe — early feasibility work on this more personalized approach suggests it may eventually replace the idea of picking one universal number for every baby [9]. One such larger effort, from the same group of researchers, is already registered and testing breathing-support pressure during the first minutes after birth more broadly [10]. Families interested in a related question — how long, rather than at what pressure, breathing support should continue in the days after birth — may find In[Neo]Sight's article on extending CPAP duration a helpful companion read (Two Extra Weeks of Nasal CPAP and Measurable Alveolar Growth at Six Months in Stable Preterm Infants).

Until that larger evidence arrives, families can trust that neonatal teams are actively working to replace inherited habit with real evidence, one carefully conducted study at a time — and that a trial willing to publish an honest "we don't know yet, but here is what we learned trying to find out" is exactly the kind of science that eventually gets premature babies better care.

References

  1. Cavigioli F, Bresesti I, Castoldi F, et al. Initial CPAP of 5 versus 8 cmH2O during delivery room stabilisation of very preterm infants: the PHILODENDROOM pilot randomised trial. Eur J Pediatr. 2026;185(9):673. doi:10.1007/s00431-026-07322-6 ↩
  2. Claireaux AE. Hyaline membrane in the neonatal lung. Lancet. 1953;262(6796):749-753. doi:10.1016/S0140-6736(53)91451-291451-2) ↩
  3. Ho JJ, Subramaniam P, Davis PG. Continuous positive airway pressure (CPAP) for respiratory distress in preterm infants. Cochrane Database Syst Rev. 2020;10:CD002271. doi:10.1002/14651858.CD002271.pub3 ↩
  4. Sweet DG, Carnielli VP, Greisen G, et al. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2025. Neonatology. 2026:1-26. doi:10.1159/000551062 ↩
  5. Tingay DG, Pereira-Fantini PM, Oakley R, et al. Gradual aeration at birth is more lung protective than a sustained inflation in preterm lambs. Am J Respir Crit Care Med. 2019;200(5):608-616. doi:10.1164/rccm.201807-1397OC ↩
  6. Sartorius V, Loi B, Vivalda L, et al. Effect of different CPAP levels on ultrasound-assessed lung aeration and gas exchange. Respir Res. 2024;25(1):375. doi:10.1186/s12931-024-03010-x ↩
  7. Mukerji A, Wahab MGA, Mitra S, et al. High continuous positive airway pressure in neonates. Pediatr Pulmonol. 2019;54(7):1039-1044. doi:10.1002/ppul.24312 ↩
  8. Duman N, Durukan Tosun M, Tuzun F, et al. Non-invasive open lung strategy in delivery room (OpenCPAP-DR): a randomized controlled trial. Eur J Pediatr. 2025;184(12):766. doi:10.1007/s00431-025-06613-8 ↩
  9. Martherus T, Kuypers KLAM, Böhringer S, et al. Feasibility and effect of physiological-based CPAP in preterm infants at birth. Front Pediatr. 2021;9:777614. doi:10.3389/fped.2021.777614 ↩
  10. Tingay DG, Galletta L, Owen LS, et al. Positive end-expiratory pressure levels during resuscitation of preterm infants at birth (POLAR): study protocol for a randomised controlled trial. Pediatr Res. 2026. doi:10.1038/s41390-026-04942-4 ↩