A Redesigned Breathing Tube for Giving Premature Babies the Medicine Their Lungs Need

What a study of 138 premature babies in six Chinese hospitals (Gao et al., Frontiers in Pediatrics 2026) found when comparing two ways of delivering surfactant

Premature babies often lack surfactant, a substance that keeps the tiny air sacs in the lungs from collapsing, so doctors give it as a medicine soon after birth. A study of 138 babies in six Chinese hospitals compared the usual method — a thin tube passed briefly into the windpipe — with a newly designed breathing tube that has a built-in channel for the medicine. The two worked about equally well, but the study was small and could not rule out real differences.

Why This Question Matters, and How Families Faced It Before

The study at the centre of this article [1] is about a piece of equipment, but the problem it tries to solve is much older than the device. Babies born early often arrive before their lungs have finished a crucial step of development. Deep inside healthy lungs, millions of microscopic air sacs stay open because they are coated with surfactant, a soapy substance that lowers surface tension. Without enough of it, the air sacs collapse with every breath out, and the baby has to fight to reopen them. This is respiratory distress syndrome, and for decades it was one of the most dangerous complications of prematurity [2].

The discovery that surfactant could be manufactured and given directly into a baby's lungs was one of the great advances of newborn medicine. Guidelines around the world now recommend giving it early to babies with signs of the condition [3][4]. But there has always been a second question alongside "should we give it?" — namely, "how do we get it in without doing harm along the way?"

For many years the answer was a technique called InSurE, short for Intubation–Surfactant–Extubation. A breathing tube was placed into the windpipe, the medicine was given down it, the ventilator pushed a few breaths to spread it through the lungs, and the tube was taken out again as quickly as possible. The baby then went back to a gentler form of support, usually CPAP, which delivers a steady cushion of pressurised air through soft prongs in the nose to hold the air sacs open. Combining surfactant with this kind of non-invasive support, rather than leaving babies on a ventilator, became standard [5].

Even so, InSurE meant a breathing tube and a burst of machine breathing. Doctors wanted something gentler. That led to LISA — less invasive surfactant administration — in which a very thin, flexible catheter is slipped between the vocal cords while the baby keeps breathing on their own, the medicine is trickled in, and the catheter is withdrawn. No breathing tube, no ventilator breaths. Large trials in several countries showed this approach worked, and it has since become the preferred method in many places [6][7]. Studies comparing LISA directly with InSurE have generally given LISA a modest edge in helping babies avoid the ventilator, without clear differences in survival [8][9][10].

Here is where the story becomes practical rather than scientific. LISA is a skilled procedure. It requires looking directly at a wide-awake baby's vocal cords with a laryngoscope and threading a fine catheter through them, and it takes practice to do well. Even the type of catheter changes how easy it is; researchers have run trials comparing stiffer and softer catheters for exactly this reason [11]. Hospitals that care for fewer premature babies, or that cannot easily obtain the special catheters, may not be able to offer LISA reliably. Their babies still need surfactant. This is the gap the study described here set out to address [1].

What the Researchers Did

A team of Chinese doctors designed a different piece of equipment: a breathing tube with two passages instead of one. The main passage does what a normal breathing tube does. Running inside its wall is a second, hair-thin channel, about 0.2 mm across, that opens near the tip. Surfactant can be injected down this channel while the baby stays connected to breathing support — the medicine and the air do not have to take turns. The tube comes in four sizes matched to a baby's weight. It had already been tested in an earlier, smaller study before this trial began [12], and the plan for this trial was published in advance so others could check it [13].

One fact belongs here plainly: the tube was invented by the same doctors who ran the trial, and it is protected by a patent (number CN 209645598 U). That does not mean the results are wrong. It does mean the researchers have an interest in the device succeeding, and readers are entitled to know that when weighing what they found.

The trial was registered with the Chinese Clinical Trial Registry under the number ChiCTR2300076354 and took place in six specialist newborn intensive care units, all in Yunnan Province in southwest China — in the cities of Kunming, Wenshan, Qujing, Zhaotong, Baoshan and Yuxi. Babies were enrolled between January 2024 and January 2025. To take part, a baby had to be born at 32 weeks of pregnancy or earlier, be admitted within six hours of birth, show signs of respiratory distress syndrome on examination and X-ray, and need extra oxygen. Parents gave written consent. The researchers screened 596 babies, randomly assigned 151 to one method or the other, and 138 completed the study — 69 in each group. Both groups received the same surfactant medicines at the same doses.

Two details about how the trial was run matter a great deal. First, no sedation, pain relief or muscle relaxant was given to any baby in either group, because the study protocol specified that. Many hospitals elsewhere do give medication before this kind of procedure, so anything the study says about how long the procedure took or how well babies tolerated it may not apply in those units. Second, the doctors performing the procedures were mostly experienced, so this was not a test of whether beginners could manage the techniques.

The main thing the researchers measured was how many babies ended up needing a ventilator within 72 hours because gentler support was not enough. Importantly, this was a non-inferiority trial — the aim was not to show the new tube was better, but to check it was not meaningfully worse. The researchers decided in advance that a gap of up to 20 percentage points would count as "not meaningfully worse". That is a very wide allowance for a study of only 138 babies.

What They Found

Ten of the 69 babies given surfactant through the new tube (14.5%) needed a ventilator within 72 hours, compared with 13 of the 69 given LISA (18.8%). The difference was 4.3 percentage points in favour of the new tube, but the range of uncertainty around that figure stretched from 12.5 points better to 4 points worse, and the comparison was not statistically significant — meaning a gap this size could easily have arisen by chance. In plain terms: no difference was detected. That is not the same as proving the two methods are equally good — with this many babies and such a wide allowance, a genuinely important difference could still be hiding in the numbers. The paper's own reasoning about this is also inconsistent: its statistics section describes one way of testing the result, while its conclusion argues from the opposite direction. Both happen to give the same answer here, but the safest reading remains "no difference detected".

The procedures took similar amounts of time — about 18 minutes with the new tube versus 20 minutes with LISA — and there were no significant differences in heart-rate problems, low oxygen episodes, mouth injuries or uneven spread of the medicine. Rates of the serious complications of prematurity were similar in both groups, including collapsed lung, bowel and eye problems, and bleeding in the brain. Chronic lung disease of prematurity was recorded in 30.4% of the new-tube group and 23.2% of the LISA group, but this difference was not statistically significant (P = 0.442) and the study was far too small to answer that question; it is a hint worth investigating, nothing more.

The one clear difference was in blood chemistry. Straight after the medicine was given, the blood of babies in the new-tube group was slightly more acidic — a pH of 7.27 compared with 7.38 in the LISA group, a difference unlikely to be chance. This most likely reflects the brief burst of pressurised breathing used to spread the medicine, and it was not accompanied by worse oxygen levels. It is not evidence of harm, but it is a real finding and should not be tucked away.

For Families, and What Comes Next

If your baby is cared for in a unit that already performs LISA well, nothing in this study suggests changing. The researchers themselves say the new tube is meant for places where LISA is hard to provide, "rather than a replacement for standard LISA in centres where the technique is well established". If your unit cannot offer LISA, this study offers early, cautious reassurance that a well-designed alternative exists.

There are gaps you should know about. Three things the researchers said they would measure were never reported: how many babies died, oxygen levels before the medicine was given, and how many attempts it took to place the tube. The paper also contains several numbers that contradict each other in places, so some of its finer details cannot be relied on. And all six hospitals were in one Chinese province, within one health system — the findings may not transfer directly elsewhere.

Researchers now need a much larger study, in more than one region, with a stricter definition of "not worse", complete reporting of every outcome promised, proper measurement of how comfortable each procedure is for the baby, and follow-up as children grow — the trial team has already said they intend to check these babies at one year of corrected age. Ideally, some of that work will be done by researchers who do not hold the patent.

References

  1. Gao J, Xiong H, Li C, Yu W, Yang J, Nie P, Bao L, Yang H, Shi Y. A novel double-lumen tracheal tube-assisted InSurE versus LISA in preterm infants with RDS: a multicenter randomized trial. Frontiers in Pediatrics. 2026;14:1869213. doi:10.3389/fped.2026.1869213 ↩
  2. Pattnaik P, Adebisi K, Lee B. Neonatal Respiratory Distress Syndrome. Treasure Island (FL): StatPearls Publishing; 2026. No DOI is recorded for this entry in the source's reference list; the identifier given is the StatPearls Publishing book record. ↩
  3. Polin RA, Carlo WA, Papile L-A, et al. Surfactant replacement therapy for preterm and term neonates with respiratory distress. Pediatrics. 2014;133(1):156–63. doi:10.1542/peds.2013-3443 ↩
  4. Ng EH, Shah V. Guidelines for surfactant replacement therapy in neonates. Paediatrics & Child Health. 2021;26(1):35–49. doi:10.1093/pch/pxaa116 ↩
  5. Shi ZN, Zhang X, Du CY, Zhao B, Liu SG. Effects of pulmonary surfactant combined with noninvasive positive pressure ventilation in neonates with respiratory distress syndrome. World Journal of Clinical Cases. 2024;12(23):5366–73. doi:10.12998/wjcc.v12.i23.5366 ↩
  6. Kakkilaya V, Gautham KS. Should less invasive surfactant administration (LISA) become routine practice in US neonatal units? Pediatric Research. 2023;93(5):1188–98. doi:10.1038/s41390-022-02265-8 ↩
  7. Budajaja F, Lahage N, Hand IL. Non-invasive surfactant administration in preterm infants. Children. 2026;13(1):150. doi:10.3390/children13010150 ↩
  8. Mishra A, Joshi A, Londhe A, Deshmukh L. Surfactant administration in preterm babies (28–36 weeks) with respiratory distress syndrome: LISA versus InSurE, an open-label randomized controlled trial. Pediatric Pulmonology. 2023;58(3):738–45. doi:10.1002/ppul.26246 ↩
  9. Hooda S, Dalal JS, Bhalla K, Vaswani ND, Dalal M. Less invasive surfactant administration (LISA) versus intubation surfactant extubation (InSurE) technique using higher volume surfactant in management of neonates with respiratory distress syndrome: an open-label randomized controlled trial. European Journal of Pediatrics. 2025;184(6):371. doi:10.1007/s00431-025-06191-9 ↩
  10. Silahli M, Tekin M. The comparison of LISA and INSURE techniques in term of neonatal morbidities and mortality among premature infants. Acta Bio-Medica: Atenei Parmensis. 2020;91(4):e2020189. doi:10.23750/abm.v91i4.8845 ↩
  11. Auer-Hackenberg L, Brandner J, Hofstätter E, Stroicz P, Hager T, Eichhorn A, et al. A pilot study of evaluation of semi-rigid and flexible catheters for less invasive surfactant administration in preterm infants with respiratory distress syndrome — a randomized controlled trial. BMC Pediatrics. 2022;22(1):637. doi:10.1186/s12887-022-03714-3 ↩
  12. Li C, Du Y, Yang K, Cao H, Yang H, Zhang CX, et al. Safety and efficacy of a novel double-lumen tracheal tube in neonates with RDS: a prospective cohort study. Frontiers in Pediatrics. 2022;10:1032044. doi:10.3389/fped.2022.1032044 ↩
  13. Gao J, Xiong H, Nie P, Yang H, Li D, Deng X, et al. Application of a new type of double-lumen endotracheal tube in preterm infants with respiratory distress syndrome: study protocol for a non-inferiority randomised controlled trial (NISA). BMJ Open. 2024;14(12):e083508. doi:10.1136/bmjopen-2023-083508 ↩