The Small Soft Device That Could Help More Babies Breathe in Their First Minutes

Four studies from Philadelphia, Vienna, Stockholm and Melbourne examine why a proven newborn airway device is rarely used, how to tell it is in the right place, whether it can be made small enough for premature babies, and what it should not be used for

When a baby does not breathe well at birth, the most important thing anyone can do is get air into the lungs. Most of the time this is done with a small face mask, but face masks leak more often than people realise, and the alternative — a breathing tube passed through the vocal cords — is a difficult skill that fewer clinicians now get to practise. A third option exists: a soft device that sits above the voice box, takes seconds to insert, and can be used after only brief training.

Why getting air in is harder than it looks

The first breaths a baby takes do something remarkable. The lungs, which have been full of fluid for nine months, clear that fluid and fill with air for the first time. Most babies manage it themselves. About one in ten needs some help, and for that small group the help has to work quickly and well.

The usual help is a face mask held over the baby's nose and mouth, connected to a device that delivers gentle puffs of air. It looks simple. It is not. When researchers measured what was actually being delivered during mask breathing for premature babies, they found that large amounts of air were escaping around the edges of the mask, or that the airway was blocked, often without the person holding the mask realising anything was wrong [1]. The person is doing everything the way they were taught, and very little air is reaching the lungs.

The backup plan is a breathing tube — intubation — placed through the vocal cords into the windpipe. It works reliably when it works, but it is a hard skill to learn and an even harder one to keep. A large international study of neonatal intubation found that around one in five attempts was accompanied by a complication, and in many hospitals the clinicians present at a birth are simply not people who intubate often [2].

Where the third option came from

The device in question goes by several names: a laryngeal mask, or more generally a supraglottic airway — "supraglottic" simply meaning "above the voice box." It is a small, soft, cuffless shape on the end of a short tube that is slid into the mouth and settles over the entrance to the windpipe, sealing gently around it. Nothing passes through the vocal cords. Insertion typically takes a few seconds.

Doctors and nurses have used versions of this device in adults and older children for decades, and it was tried in newborns as early as the 1990s. A 2013 review of the trials available at the time concluded it was a safe alternative to the face mask for larger newborns, while noting there was almost no information about babies below about 34 weeks of pregnancy or 1,500 grams [3].

The most important tests took place in Uganda. A first randomised trial at Mulago National Referral Hospital in Kampala showed that midwives — not specialist doctors — could use the device well [4]. A larger follow-up study, the NeoSupra trial at the same hospital, compared the device against the face mask in newborns who needed help breathing, all of them at least 34 weeks or 2,000 grams. Roughly 1,150 babies took part. The combined result of death within seven days or admission to newborn intensive care with a serious brain injury from lack of oxygen happened in 154 of 563 babies (27.4%) in the device group and 144 of 591 (24.4%) in the face-mask group — very close, with no advantage for the device on these outcomes. It was safe in midwives' hands, but it did not save more lives in that setting [5].

That sounds like a disappointing result, and for a while it was read that way. But it measured the wrong thing. When international resuscitation experts pooled six randomised trials covering 1,823 babies, they found a different and clearer picture: with the device, babies were far less likely to fail to improve with assisted breathing, and far less likely to need a breathing tube [6]. A separate analysis of studies from low- and middle-income countries agreed [7]. In other words, the device is better at the job of getting air in — which is the job that matters in the first minutes. On that basis, both American [8] and European [9] newborn resuscitation guidelines now recommend it for babies born at 34 weeks or later.

And then almost nobody used it. In a survey of more than 5,000 American clinicians trained in newborn resuscitation, only 12% had ever used one. The reasons they gave were about habit and confidence rather than doubt about the evidence: not enough experience, a preference for what they already knew, and — strikingly — simply not thinking of it in the moment [10].

Four recent studies, four different questions

Why don't people use it? A team at the Children's Hospital of Philadelphia, working with a network of American hospitals convened by the American Academy of Pediatrics, spent a year systematically asking that question before designing a large trial called SUGAR — the Supraglottic Airway for Resuscitation trial [11]. They read 565 written comments from clinicians and held focus groups. The answers were human. Hospitals owned the devices but nobody could find them during a practice drill. Intubation was described as "the culture." One doctor admitted a private worry: if we start using this, I will lose the chance to practise the harder skill I might need one day. Interestingly, clinicians at smaller and rural hospitals were the keenest — they know that no one skilled at intubation may be in the building. The team then designed a set of practical fixes to test: local champions, hands-on practice with video, checklists, putting the device into the standard airway kit, and training the trainers.

How do you know it's in the right place? Doctors at the Medical University of Vienna combined the device with a small monitor that measures, breath by breath, how much air is actually going in and how much is leaking out [12]. Six babies were studied. When the clinician could see the monitor, they needed one attempt on average; when the screen was hidden, three. In the two babies where it was hidden, more than half and then over nine-tenths of the air was escaping after the first insertion. When the monitor was visible, small nudges of the device — a slight angle, a little deeper — dropped leakage from three-quarters to under a fifth. A camera passed through the device in four babies confirmed that low leakage really did mean correct position. Six babies is a very small study, and these were planned procedures in intensive care rather than emergency births, so this is a promising start rather than a settled answer. It fits with what is already known about the device being quick to place — roughly half the time an intubation takes [13].

Can it be made small enough for premature babies? This is the biggest gap. Guidelines stop at 34 weeks because no device is made small enough below that, which leaves out exactly the babies most likely to need breathing help. A team in Stockholm tested three new smaller prototype devices with 27 doctors and nurses on training manikins representing babies of 2,200, 950 and 500 grams [14]. The results were encouraging: insertion took about six seconds, most participants rated the devices very good, and for each manikin size at least one device sealed acceptably. But two warning signs appeared. On the smallest manikin, the volume of air being pushed in was sometimes far higher than a real 500-gram baby's lungs could safely tolerate, and the pressures used ran consistently above what had been set. The researchers traced the pressure problem to the warming-bed equipment rather than the devices themselves — but the lesson is that if these devices reach real babies, careful training on how fast and how hard to squeeze must come with them. A separate imaging study of the same prototypes supports the anatomical fit [15]. Manikins are not babies, and the researchers say so plainly: a plastic model has no muscle tone, no mucus, no rising heart rate to tell you it is working.

What should it not be used for? A commentary in the journal Pediatric Research reviewed an animal study asking whether emergency adrenaline — a drug given to the very sickest newborns whose hearts are not responding — could be delivered through the device [16], [17]. It could not, at least not well: the drug reached the bloodstream but produced almost no effect on the heart. Since even the breathing-tube route for adrenaline works poorly — in one national database, only about half of babies given it that way responded without also needing it through a vein [18] — this is a door that has now been sensibly closed. For a baby who needs adrenaline, a line into a vein remains the priority.

What this means for families, and what comes next

If your baby needed help breathing at birth and this device was used, it was not a sign that something went wrong. It is a gentle, fast way of opening the lungs that avoids passing a tube through the vocal cords, and the evidence says it often works better than a mask alone. If your baby was born very prematurely, the device probably was not an option — the small sizes are still prototypes.

Researchers are working on three things. Whether the leak monitor helps in a real delivery room, not just in intensive care. Whether the small devices are safe in genuinely tiny babies, with the volume and pressure concerns solved first. And whether a well-designed training and equipment programme can move a 12% usage rate — the question SUGAR was built to answer. A related use is already further along: giving surfactant, the medicine that helps premature lungs stay open, through the device instead of through a breathing tube, which a major evidence review suggests may reduce the need for a ventilator [19], supported by a randomised comparison against brief intubation [20]. None of this replaces skilled hands. It gives more hands something reliable to reach for.

References

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  2. Foglia EE, Ades A, Sawyer T, et al. Neonatal intubation practice and outcomes: an international registry study. Pediatrics. 2019;143(1):e20180902. doi:10.1542/peds.2018-0902 ↩
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