SHINE Trial Shows that Vapotherm® Improved Chances for Successful Intubation in Preterm Babies

In April 2022, Hodgson and colleagues published the results of a randomized controlled trial in the New England Journal of Medicine, titled “Nasal High-Flow Therapy during Neonatal Endotracheal Intubation.”1 The study, also known as the SHINE trial, followed a previously published protocol2 and examined whether use of high flow nasal cannula would improve the likelihood of first-time success of intubations in neonates. The authors concluded that this intervention does improve success by comparison to treatment as usual (TAU), which does not include supplemental oxygen. It’s worth noting that though the authors refer to the therapy as “nasal high-flow,” the trial was conducted using exclusively Vapotherm high velocity therapy, which is an advanced form of high flow.

Context and Methods

Approximately half or more of intubations in NICUs fail on the first attempt, leading to increased risk of adverse events.1 When it comes to children and adults, it’s known that respiratory support via high flow or high velocity helps prolong the period before desaturation in intubations. There were no previously collected data on this in the neonatal population, hence why the SHINE trial focuses on this question.

Hodgson and colleagues included 251 intubations across 209 infants with a mean gestational age of 27 weeks and mean weight of 920g —multiple intubations per infant were included so long as they could be considered independent events. 124 intubations were randomized to the high velocity arm and 127 were randomized to TAU with infants in both groups sharing similar baseline demographic and clinical characteristics. The primary endpoint was successful intubation on the first attempt without physiological instability in the baby. The authors defined physiological instability as desaturation of more than 20% or bradycardia. The intubations were recorded on video for data accuracy and interpretational bias reduction.

Outcomes and Conclusion

The results (see Table 1) show that intubations had a greater first-attempt success rate on babies supported with high velocity therapy as compared to TAU. The 31.5% success rate in the standard care group is consistent with previous data from the lead site, where 29% of the infants were successfully intubated on first try without physiological instability. The duration of the procedure was no longer in the high velocity group despite the greater success rate.

Table 1: Primary Outcomes of SHINE Trial

High Velocity
n = 124
Treatment as Usual
n = 127
Successful Intubation on First Attempt Without Physiological Instability62 (50%)40 (31.5%)
Successful Intubation on First Attempt85 (68.5%)69 (54.3%)
No Physiological Instability79 (63.7%)64 (50.4%)

Subgroup analyses showed that the effect on the likelihood of success was larger in physicians who have less experience with neonatal intubations.

Not All Therapies are the Same

The SHINE study adds to the body of evidence of the efficacy of Vapotherm high velocity therapy in the NICU setting. Randomized controlled studies show it to be as effective as CPAP for primary support and post-extubation support in the NICU.3,4 A recent study by Siva and Reynolds also showed successful use of high velocity therapy for primary respiratory support in the delivery room.5

With the growth of clinical evidence, it’s important for practitioners to know which therapy was used in trials. As seen with the SHINE study and numerous others, it is still a research convention to conflate high flow nasal cannula and high velocity therapy into one term, even though the two are mechanistically different and have not always shown the same clinical outcomes.6,7,8 Practitioners should read closely to make the most informed decisions about clinical practice.

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[1] Hodgson KA, Owen LS, Kamlin COF, Roberts CT, Newman SE, Francis KL, Donath SM, Davis PG, Manley BJ. Nasal High-Flow Therapy during Neonatal Endotracheal Intubation. N Engl J Med 2022;386:1627-37.DOI: 10.1056/NEJMoa2116735
[2] Hodgson KA, Owen LS, Kamlin CO, et al. A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): a study protocol. BMJ Open 2020; 10(10): e039230.
[3] Lavizzari A, Colnaghi M, Ciuffini F, Veneroni C, Musumeci S, Cortinovis I, Mosca F. “Heated, humidified high-flow nasal cannula vs nasal continuous positive airway pressure for respiratory distress syndrome of prematurity – a randomized clinical noninferiority trial.” JAMA Pediatr. 2016 Aug 8.
[4] Collins C, Holberton J, Barfield C, Davis P. “A randomized controlled trial to compare heated humidified high-flow nasal cannulae with nasal continuous positive airway pressure postextubation in premature infants.” J Pediatrics. 2013 May; 162: 949-54
[5] Siva NV, Reynolds PR. Stabilisation of the preterm infant in the delivery room using nasal high flow: A 5—year retrospective analysis. Acta Paediatr. 2021;00:1–7.
[6] Manley, Brett J., M.B., B.S., Louise S. Owen, M.D., Lex W. Doyle, M.D., Chad C. Andersen, M.B., B.S., David W. Cartwright, M.B., B.S., Margo A. Pritchard, Ph.D., Susan M. Donath, M.A., and Peter G. Davis, M.D. “High-Flow Nasal Cannulae in Very Preterm Infants after Extubation.” New England Journal of Medicine. October 10, 2013. 1425-1433.
[7] Roberts, Calum T., M.B., Ch.B., Louise S. Owen, M.D., Brett J. Manley, Ph.D., Dag H. Frøisland, Ph.D., Susan M. Donath, M.A., Kim M. Dalziel, Ph.D., Margo A. Pritchard, Ph.D., David W. Cartwright, M.B., B.S., Clare L. Collins, M.D., Atul Malhotra, M.D., and Peter G. Davis, M.D. for the HIPSTER Trial Investigators. “Nasal High-Flow Therapy for Primary Respiratory Support in Preterm Infants.” New England Journal of Medicine. September 22, 2016; 375:1142-1151.
[8] Manley, Brett J., et al. Nasal High-Flow Therapy for Newborn Infants in Special Care Nurseries. N Engl J Med 2019; 380:2031-2040. DOI: 10.1056/NEJMoa1812077