NeoSupra Trial

The Tap4Life team do research on their products to assess the quality of the products and the feasibility. We publish our results in peer-reviewed academic journals.

Neonatal Supraglottic Device Trial- NeoSupra Trial: In december 2015 our team received a research grant FRIMEDBIO from the Research Council of Norway to conduct a phase II study on ventilation in neonatal resuscitation in low-resource settings. As part of the trial NeoTapAS and NeoTapLS is used. The trial was conducted at Mulago National Referral Hospital, Kampala, Uganda. The recruitments started 8th of May 2018 and ended the 12th of August 2019, a total of 1163 resuscitation was recruited and all were video filmed. Two members of the Tap4Life team, Dr Susanna Myrnerts Höök and Dr Nicolas Pejovic, have on and off been living in Uganda to run the trial giving the Tap4Life team excellent insight in the challenging work at a referral hospital in a low-resource setting. “Neonatal Resuscitation with Supraglottic Airway Trial” (NeoSupra), ClinicalTrials.gov NCT03133572, https://clinicaltrials.gov/ct2/show/NCT03133572.

  • Pejovic NJ*, Myrnerts Höök S*, Byamugisha J, Alfvén T, Lubulwa C, Cavallin F, Nankunda J, Ersdal E, Blennow M, Trevisanuto D, Tylleskär T. A randomized trial of laryngeal mask airway in neonatal resuscitation. The New England Journal of Medicine 2020;383:2138-47. Doi:10.1056/NEJMoa2005333. *contributed equally to this article.
  • Pejovic NJ, Myrnerts Höök S, Byamugisha J, Trevisanuto D, et al. Neonatal resuscitation using a supraglottic airway device for improved mortality and morbidity outcomes in a low-income country: study protocol for a randomized trial. doi: 10.1186/s13063-019-3455-8. Trials. 2019 Jul 19;20(1):444.

Prior to the NeoSupra trial we conducted a manikin study and a phase II trial involving NeoTap:

  • Pejovic NJ, Trevisanuto D, Nankunda J, Tylleskär T. Pilot manikin study showed that a supraglottic airway device improved simulated neonatal ventilation in a low-resource setting. doi: 10.1111/apa.13565 Acta Paediatr. 2016 Dec;105(12):1440-1443. https://clinicaltrials.gov/ct2/show/NCT02042118.
  • Pejovic NJ, Trevisanuto D, Lubulwa C, et al. Neonatal resuscitation using a laryngeal mask airway: a randomised trial in Uganda. Arch Dis Child. 2017. DOI:10.1136/archdischild-2017-312934