Incorporating nasal high-flow therapy during endotracheal intubation attempts in the neonatal intensive care unit (NICU) increased the chance of success on the first try, a randomized study found.

In the SHINE trial of just over 250 intubation attempts at a pair of Australian NICUs, 50% of those that included high-flow therapy had a successful first attempt without physiological instability — the study’s primary endpoint — as compared to 31.5% of those assigned to standard care (adjusted risk difference 17.6%, 95% CI 6.0-29.2), according to Kate Hodgson, MBBS, of the Newborn Research Centre and Royal Women’s Hospital in Victoria, Australia, and colleagues.

One infant benefited from the addition of high-flow therapy for every six treated (95% CI 4-17), they reported in the New England Journal of Medicine.

Intubation is required for the most premature infants as well as the sickest infants, but opportunities for physicians to gain experience have decreased over the years, explained Hodgson and colleagues, driven by “increasing use of noninvasive respiratory support, the availability of less invasive surfactant administration techniques for use in preterm infants, and recommendations against routine endotracheal suctioning in infants born through meconium-stained amniotic fluid.”

Rates of success on the first attempt are low, with one study showing a range from 23% to 60% depending on the clinician’s experience, with physiological instability the most common reason for stopping an intubation attempt.

In a subgroup analysis of the primary endpoint, the effect of the intervention was greatest in “inexperienced” operators (<20 prior intubations):

• Inexperienced: 49.2% vs 15.7% (adjusted risk difference 33.3%, 95% CI 18.3-48.2)
• Experienced: 50.8% vs 42.1% (adjusted risk difference 7.5%, 95% CI -9.4 to 24.3)

No desaturation occurred in 71.8% of infants in the high-flow group compared with 60.6% of those in the standard-care group (adjusted risk difference 13.1%, 95% CI 4.1-22.1).

“A neonate’s condition is often clinically unstable during intubation because neonates have a lower functional residual capacity and greater metabolic demand than older children and adults,” noted Hodgson and colleagues. “In the neonatal unit, an infant’s oxygen saturation falls by 20% or more from the preintubation baseline level in approximately half the intubations performed.”

The SHINE trial‘s primary intention-to-treat analysis included 251 intubation attempts (involving 202 infants) that were randomized to either nasal high-flow therapy or standard care from November 2018 to April 2021. Mean time to insert the nasal prongs was 9.9 seconds in the high-flow group.

Baseline characteristics were similar between groups, with infants (55-57% male) having a median age of 10 hours, a median gestational age of 27 weeks, and a median weight of 920 g (about 2 lbs) at intubation. About three-fourths were delivered by C-section and the intubation attempt was performed in the NICU in three-fourths of the cases and in the delivery room in the rest. Prior to intubation, nearly all had received continuous positive airway pressure (89-91%) and only 2-3% had received no respiratory support whatsoever.

For the primary endpoint, 62 of 124 intubations were successful on first attempt without physiological instability in the high-flow arm versus 40 of 127 in the standard-care arm. Procedures were recorded via a GoPro camera and the videos were reviewed to confirm the primary outcome. The effect of high-flow oxygen was seen regardless of premedication use or the infants’ post-menstrual age (≤28 weeks or >28 weeks).

For successful first-attempt intubation without regard for physiological stability, the difference between study arms was 68.5% versus 54.3% in favor of the intervention (adjusted risk difference 15.8%, 95% CI 4.3-27.3).

For secondary endpoints, median oxygen saturation during the first intubation attempt was higher in the high-flow therapy group (93.5% vs 88.5%), and the average time to desaturation was longer in the high-flow group for infants with an episode of desaturation (44.3 vs 35.5 seconds). No differences were seen for median number of intubation attempts, duration of attempts, the percentage of intubations with a serious adverse event, or other outcomes.

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