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Resuscitation. 2017 Jul;116:66-72. doi: 10.1016/j.resuscitation.2017.04.012. Epub 2017 Apr 17.

Born not breathing: A randomised trial comparing two self-inflating bag-masks during newborn resuscitation in Tanzania.

Author information

1
Institute of Clinical Medicine, Institute for Experimental Medical Research, Faculty of Medicine, University of Oslo, P.O. Box 4956, Nydalen, 0424 Oslo, Norway. Electronic address: thallingermonica@hotmail.com.
2
Stavanger University Hospital, Department of Anaesthesiology & Intensive Care and SAFER, PO Box 8100, N-4068 Stavanger, Norway. Electronic address: hege.ersdal@safer.net.
3
Maternity Ward, Haydom Lutheran Hospital, Haydom, Manyara, Tanzania. Electronic address: fortufrancis@gmail.com.
4
Research Centre, Haydom Lutheran Hospital, Haydom, Manyara, Tanzania. Electronic address: yeconia@gmail.com.
5
Research Centre, Haydom Lutheran Hospital, Haydom, Manyara, Tanzania. Electronic address: estomduma@gmail.com.
6
Department of Obstetrics and Gynecology, Muhimbili National Hospital/MUHAS, Dar Es Salaam, Tanzania. Electronic address: hkidanto@gmail.com.
7
Department of Paediatrics, Stavanger University Hospital, PO Box 8100, N-4068 Stavanger, Norway. Electronic address: joga@sus.no.
8
Strategic Research, Laerdal Medical, Tanke Svilandsgate 30, N-4002 Stavanger, Norway. Electronic address: joar.eilevstjonn@laerdal.com.
9
Department of Child Health, Norwegian Institute of Public Health, PO Box 4404 Nydalen, N-0403 Oslo, Norway. Electronic address: nina.gunnes@fhi.no.
10
Department of Child Health, Norwegian Institute of Public Health, PO Box 4404 Nydalen, N-0403 Oslo, Norway. Electronic address: ketil.stordal@fhi.no.

Abstract

AIMS:

Effective ventilation is crucial to save non-breathing newborns. We compared standard equipment for newborn resuscitation to a new Upright bag, in an area with high neonatal mortality.

METHODS:

Newborns requiring resuscitation at Haydom Lutheran Hospital, Tanzania, were ventilated with 230ml standard or 320ml Upright bag-mask by weekly non-blinded block randomisation. A Laerdal Newborn Resuscitation Monitor collected ventilation data through a flow sensor between mask and bag and heart rate with electrocardiography electrodes. Primary outcome was expiratory tidal volume per birth weight.

RESULTS:

Of 6110 babies born, 136 randomised to standard bag-mask and 192 to Upright, both groups had similar birth weight, gestational age, Apgar scores, gender, and mode of delivery. Compared to standard bag-mask, Upright gave higher median expiratory tidal volume (8.6ml/kg (IQR: 3.5-13.8) vs. 10.0ml/kg (IQR: 4.3-16.8) difference ratio 1.29, 95%CI 1.05, 1.58, p=0.014)), increased mean airway and peak inspiratory pressures, and higher early expired CO2 (median at 20s 4.2% vs. 3.2%, p=0.0099). Clinical outcome 30min post-delivery was normal in 44% with standard versus 57% with Upright (p=0.016), but similar at 24h.

CONCLUSION AND RELEVANCE:

Upright provided higher expired tidal volume, MAP, PIP and early ECO2 than the standard bag. Clinical outcome differed at 30min, but not at 24h. Larger volume of Upright than standard bag can be an important factor. The results are relevant for low- and high-income settings as ventilatory and heart rate parameters during resuscitation of newborns are rarely reported. Trial registered at www.ClinicalTrials.gov, NCT01869582.

KEYWORDS:

Asphyxia Neonatorum; Bag-mask ventilation; Birth asphyxia; Developing countries; Infant mortality; Low-resource setting; Neonatal mortality; Neonatology; Newborn resuscitation; Positive Pressure Ventilation; Self-inflating bag; Stillbirth

[Indexed for MEDLINE]

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