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Neonatal resuscitation using a laryngeal mask airway: a randomised trial in Uganda
  1. Nicolas J Pejovic1,2,3,
  2. Daniele Trevisanuto4,
  3. Clare Lubulwa5,
  4. Susanna Myrnerts Höök1,2,3,
  5. Francesco Cavallin6,
  6. Josaphat Byamugisha5,7,
  7. Jolly Nankunda5,8,
  8. Thorkild Tylleskär1
  1. 1 Centre for International Health, Universitetet i Bergen, Bergen, Norway
  2. 2 Neonatal Unit, Sachs’ Children and Youth Hospital, Stockholm, Sweden
  3. 3 Department of Public Health Science, Karolinska Institute, Stockholm, Sweden
  4. 4 Department of Pediatrics, Padua University, Padua, Italy
  5. 5 Mulago National Referral Hospital, Kampala, Uganda
  6. 6 Independent statistician, Padua, Italy
  7. 7 Department of Obstetrics and Gynaecology, College of Health Sciences, Makerere University, Kampala, Uganda
  8. 8 Department of Pediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda
  1. Correspondence to Dr Nicolas J Pejovic, Department of Public Health Sciences, Tomtebodavägen, 171 77 Stockholm, Sweden; njpejovic{at}live.se

Abstract

Objective Mortality rates from birth asphyxia in low-income countries remain high. Face mask ventilation (FMV) performed by midwives is the usual method of resuscitating neonates in such settings but may not always be effective. The i-gel is a cuffless laryngeal mask airway (LMA) that could enhance neonatal resuscitation performance. We aimed to compare LMA and face mask (FM) during neonatal resuscitation in a low-resource setting.

Setting Mulago National Referral Hospital, Kampala, Uganda.

Design This prospective randomised clinical trial was conducted at the labour ward operating theatre. After a brief training on LMA and FM use, infants with a birth weight >2000 g and requiring positive pressure ventilation at birth were randomised to resuscitation by LMA or FM. Resuscitations were video recorded.

Main outcome measures Time to spontaneous breathing.

Results Forty-nine (24 in the LMA and 25 in the FM arm) out of 50 enrolled patients were analysed. Baseline characteristics were comparable between the two arms. Time to spontaneous breathing was shorter in LMA arm than in FM arm (mean 153 s (SD±59) vs 216 s (SD±92)). All resuscitations were effective in LMA arm, whereas 11 patients receiving FM were converted to LMA because response to FMV was unsatisfactory. There were no adverse effects.

Conclusion A cuffless LMA was more effective than FM in reducing time to spontaneous breathing. LMA seems to be safe and effective in clinical practice after a short training programme. Its potential benefits on long-term outcomes need to be assessed in a larger trial.

Clinical trial registry This trial was registered in https://clinicaltrials.gov, with registration number NCT02042118.

  • Global Health
  • Resuscitation
  • Newborn Infant
  • Asphyxia Neonatorum
  • Laryngeal Masks

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors NJP had the idea and was responsible for conception and design, outcome assessment, acquisition of data, data analysis and interpretation, and drafted the manuscript. DT was responsible for trial design, outcome assessment, data analysis and manuscript writing. CL was responsible for on-site trial planning, data gathering, data analysis and critically revising the manuscript for important intellectual content. JN was responsible for on-site trial planning, data analysis, and critically revising the manuscript for important intellectual content. SMH was responsible for outcome assessment, acquisition of data, data analysis and interpretation, and critically revising the manuscript for important intellectual content. JB was responsible for on-site trial planning, data analysis and interpretation, and critically revising the manuscript for important intellectual content. FC was responsible for statistical analysis and interpretation, and critically revising the manuscript for important intellectual content. TT was responsible for conception and design, outcome assessment, data analysis and interpretation, and critically revising the manuscript for important intellectual content.

  • Funding This study was funded by Laerdal Foundation for Acute Medicine.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval Institutional Review Board (IRB) of Mulago National Referral Hospital, the Uganda National Council of Science and Technology, the National Drug Authority and by the Regional Committee for Medical and Health Research Ethics (REK VEST) in Norway.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement All authors of this article accept to share the complete dataset of this article. The data will be made available for all reasonable requests by online access with a password.

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