HMN 2025: How Nasal mask support improves breathing in preterm babies in clinical trial

Using a nasal mask instead of a traditional face mask to support very premature babies at birth can significantly reduce the need for rescue breathing and escalation of care, a world-first trial led by researchers at Monash University’s School of Clinical Sciences at Monash Health, in collaboration with Hudson Institute of Medical Research and Monash Children’s Hospital (Monash Health), has shown.

Published today in The Lancet Child & Adolescent Health, the FONDUE trial (“Face mask versus nasal mask device use for initial resuscitation in extremely and very premature infants“) enrolled 151 newborns born between 23 and 31 weeks’ gestation at Monash Children’s Hospital.

Nearly all babies born more than two months early require help breathing immediately after birth. Many of these fragile newborns will take a first breath or let out a cry, but then stop breathing and need urgent help from doctors and nurses to keep oxygen flowing to their tiny lungs. This urgent intervention, known as positive pressure ventilation or “rescue breathing,” is life-saving but can also expose the preterm lung to high inflation pressures that cause damage.

If rescue breathing with a face mask is unsuccessful, clinicians may have to escalate to placing a breathing tube into the lungs via an emergency intubation. It is widely accepted that supporting a preterm baby to continue to breathe spontaneously and avoid intubation will lead to the best long-term outcome.

The FONDUE trial found that providing initial support through a nasal mask meant fewer babies needed this kind of rescue breathing. Lead author Dr. Douglas Blank, researcher in Monash University’s School of Clinical Sciences and Hudson Institute of Medical Research, and Newborn Consultant at Monash Children’s Hospital, said “In our trial, we reduced the need for rescue breathing from 58% to 39% by using a nasal mask to provide initial help breathing instead of the traditional face mask.”

“We believe that this improvement in successfully supporting breathing in extremely and very preterm infants using a nasal mask is due to more newborns continuing to breathe well after birth. The findings have the potential for immediate impact to improve care of fragile preterm newborns because the intervention is simple to implement and readily available.”

Immediate clinical implications

The intervention was provided in the delivery room during the first 20 minutes of life, before infants were admitted to the neonatal intensive care unit (NICU). Researchers believe that encouraging and supporting spontaneous breathing efforts in extremely preterm babies may also improve long-term outcomes.

Senior author Associate Professor Calum Roberts, from the School of Clinical Sciences at Monash Health, said the results are especially significant for babies born before 28 weeks.

“Initial use of a nasal mask doubled the likelihood of successful breathing support without escalation in extremely preterm babies,” Associate Professor Roberts said. “Avoiding high-pressure ventilation and intubation at birth could have lasting benefits for their fragile lungs and brains.”

With more than 25,000 babies born preterm each year in Australia, the researchers said the findings could rapidly change delivery room practice.

“Encouraging spontaneous breathing from the first moments of life is a simple, low-cost change that can be adopted worldwide,” Dr. Blank said. “Our hope is that these results improve outcomes for the most vulnerable newborns.”

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