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

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 230 ml standard or 320 ml 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 (8.6 ml/kg (IQR: 3.5–13.8) vs. 10.0 ml/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 20 s 4.2% vs. 3.2%, p = 0.0099). Clinical outcome 30 min post-delivery was normal in 44% with standard versus 57% with Upright (p = 0.016), but similar at 24 h. Conclusion and relevance Upright provided higher expired tidal volume, MAP, PIP and early ECO₂ than the standard bag. Clinical outcome differed at 30 min, but not at 24 h. 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.