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Neonatal resuscitation using a supraglottic airway device for improved mortality and morbidity outcomes in a low-income country: study protocol for a randomized trial.
Trials 2019; 20(1):444T

Abstract

BACKGROUND

Intrapartum-related death is the third leading cause of under-5 mortality. Effective ventilation during neonatal resuscitation has the potential to reduce 40% of these deaths. Face-mask ventilation performed by midwives is globally the most common method of resuscitating neonates. It requires considerable operator skills and continuous training because of its complexity. The i-gel® is a cuffless supraglottic airway which is easy to insert and provides an efficient seal that prevents air leakage; it has the potential to enhance performance in neonatal resuscitation. A pilot study in Uganda demonstrated that midwives could safely resuscitate newborns with the i-gel® after a short training session. The aim of the present trial is to investigate whether the use of a cuffless supraglottic airway device compared with face-mask ventilation during neonatal resuscitation can reduce mortality and morbidity in asphyxiated neonates.

METHODS

A randomized phase III open-label superiority controlled clinical trial will be conducted at Mulago Hospital, Kampala, Uganda, in asphyxiated neonates in the delivery units. Prior to the intervention, health staff performing resuscitation will receive training in accordance with the Helping Babies Breathe curriculum with a special module for training on supraglottic airway insertion. A total of 1150 to 1240 babies (depending on cluster size) that need positive pressure ventilation and that have an expected gestational age of more than 34 weeks and an expected birth weight of more than 2000 g will be ventilated by daily unmasked randomization with a supraglottic airway device (i-gel®) (intervention group) or with a face mask (control group). The primary outcome will be a composite outcome of 7-day mortality and admission to neonatal intensive care unit (NICU) with neonatal encephalopathy.

DISCUSSION

Although indications for the beneficial effect of a supraglottic airway device in the context of neonatal resuscitation exist, so far no large studies powered to assess mortality and morbidity have been carried out. We hypothesize that effective ventilation will be easier to achieve with a supraglottic airway device than with a face mask, decreasing early neonatal mortality and brain injury from neonatal encephalopathy. The findings of this trial will be important for low and middle-resource settings where the majority of intrapartum-related events occur.

TRIAL REGISTRATION

ClinicalTrials.gov. Identifier: NCT03133572 . Registered April 28, 2017.

Authors+Show Affiliations

Centre for International Health, University of Bergen, Årstadveien 21, Box 7804, 5020, Bergen, Norway. njpejovic@live.se. Sachs' Children and Youth Hospital, Sjukhusbacken 10, 11883, Stockholm, Sweden. njpejovic@live.se. Karolinska Institutet Department of Public Health Sciences, Tomtebodavägen 18A, 171 77, Stockholm, Sweden. njpejovic@live.se.Centre for International Health, University of Bergen, Årstadveien 21, Box 7804, 5020, Bergen, Norway. Sachs' Children and Youth Hospital, Sjukhusbacken 10, 11883, Stockholm, Sweden. Karolinska Institutet Department of Public Health Sciences, Tomtebodavägen 18A, 171 77, Stockholm, Sweden.Mulago National Referral Hospital, Box 7272, Kampala, Uganda. Department of Obstetrics and Gynaecology, College of Health Sciences, Makerere University, Box 7072, Kampala, Uganda.Sachs' Children and Youth Hospital, Sjukhusbacken 10, 11883, Stockholm, Sweden. Karolinska Institutet Department of Public Health Sciences, Tomtebodavägen 18A, 171 77, Stockholm, Sweden.Mulago National Referral Hospital, Box 7272, Kampala, Uganda.Independent statistician, Solagna, Italy.Mulago National Referral Hospital, Box 7272, Kampala, Uganda. Department of Paediatrics and Child Health, College of Health Sciences, Makerere University, Box 7072, Kampala, Uganda.Department of Anaesthesiology and Intensive Care, Stavanger University Hospital, Gerd-Ragna Bloch Thorsens gate 8, 4019, Stavanger, Norway. Faculty of Health Sciences, University of Stavanger, Box 8600, 4036, Stavanger, Norway.Operational Research Unit, Doctors with Africa Cuamm, Via San Francesco 126, Padova, Italy.Department of Neonatal Medicine, Karolinska University Hospital, Eugeniavägen 3, 171 76, Stockholm, Sweden. Karolinska Institutet Department of Clinical Science, Technology and Intervention, Alfred Nobels alle 8, 141 52, Huddinge, Sweden.Department of Woman and Child Health, Padua University, Via Giustiniani, 3, 35128, Padua, Italy.Centre for International Health, University of Bergen, Årstadveien 21, Box 7804, 5020, Bergen, Norway. Centre for Intervention Science in Maternal and Child Health Centre for International Health, University of Bergen, Årstadveien 21, Box 7804, 5020, Bergen, Norway.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31324213

Citation

Pejovic, Nicolas J., 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." Trials, vol. 20, no. 1, 2019, p. 444.
Pejovic NJ, Myrnerts Höök S, Byamugisha J, 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. Trials. 2019;20(1):444.
Pejovic, N. J., Myrnerts Höök, S., Byamugisha, J., Alfvén, T., Lubulwa, C., Cavallin, F., ... Tylleskär, T. (2019). Neonatal resuscitation using a supraglottic airway device for improved mortality and morbidity outcomes in a low-income country: study protocol for a randomized trial. Trials, 20(1), p. 444. doi:10.1186/s13063-019-3455-8.
Pejovic NJ, 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. Trials. 2019 Jul 19;20(1):444. PubMed PMID: 31324213.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Neonatal resuscitation using a supraglottic airway device for improved mortality and morbidity outcomes in a low-income country: study protocol for a randomized trial. AU - Pejovic,Nicolas J, AU - Myrnerts Höök,Susanna, AU - Byamugisha,Josaphat, AU - Alfvén,Tobias, AU - Lubulwa,Clare, AU - Cavallin,Francesco, AU - Nankunda,Jolly, AU - Ersdal,Hege, AU - Segafredo,Giulia, AU - Blennow,Mats, AU - Trevisanuto,Daniele, AU - Tylleskär,Thorkild, Y1 - 2019/07/19/ PY - 2018/09/18/received PY - 2019/05/20/accepted PY - 2019/7/21/entrez PY - 2019/7/22/pubmed PY - 2019/7/22/medline KW - Asphyxia KW - Asphyxia neonatorum KW - Global health KW - Intrapartum-related complications KW - Laryngeal mask KW - Low-income country KW - Neonatal mortality KW - Newborn infant KW - Positive pressure ventilation KW - Resuscitation KW - Supraglottic airway device SP - 444 EP - 444 JF - Trials JO - Trials VL - 20 IS - 1 N2 - BACKGROUND: Intrapartum-related death is the third leading cause of under-5 mortality. Effective ventilation during neonatal resuscitation has the potential to reduce 40% of these deaths. Face-mask ventilation performed by midwives is globally the most common method of resuscitating neonates. It requires considerable operator skills and continuous training because of its complexity. The i-gel® is a cuffless supraglottic airway which is easy to insert and provides an efficient seal that prevents air leakage; it has the potential to enhance performance in neonatal resuscitation. A pilot study in Uganda demonstrated that midwives could safely resuscitate newborns with the i-gel® after a short training session. The aim of the present trial is to investigate whether the use of a cuffless supraglottic airway device compared with face-mask ventilation during neonatal resuscitation can reduce mortality and morbidity in asphyxiated neonates. METHODS: A randomized phase III open-label superiority controlled clinical trial will be conducted at Mulago Hospital, Kampala, Uganda, in asphyxiated neonates in the delivery units. Prior to the intervention, health staff performing resuscitation will receive training in accordance with the Helping Babies Breathe curriculum with a special module for training on supraglottic airway insertion. A total of 1150 to 1240 babies (depending on cluster size) that need positive pressure ventilation and that have an expected gestational age of more than 34 weeks and an expected birth weight of more than 2000 g will be ventilated by daily unmasked randomization with a supraglottic airway device (i-gel®) (intervention group) or with a face mask (control group). The primary outcome will be a composite outcome of 7-day mortality and admission to neonatal intensive care unit (NICU) with neonatal encephalopathy. DISCUSSION: Although indications for the beneficial effect of a supraglottic airway device in the context of neonatal resuscitation exist, so far no large studies powered to assess mortality and morbidity have been carried out. We hypothesize that effective ventilation will be easier to achieve with a supraglottic airway device than with a face mask, decreasing early neonatal mortality and brain injury from neonatal encephalopathy. The findings of this trial will be important for low and middle-resource settings where the majority of intrapartum-related events occur. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT03133572 . Registered April 28, 2017. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/31324213/Neonatal_resuscitation_using_a_supraglottic_airway_device_for_improved_mortality_and_morbidity_outcomes_in_a_low_income_country:_study_protocol_for_a_randomized_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3455-8 DB - PRIME DP - Unbound Medicine ER -