Supporting neonatal resuscitation in low-resource settings : Innovations and new strategies

Background: Lack of oxygen at birth, birth asphyxia, accounts annually for around 700 000 deaths. Heart rate is important in evaluating a neonate and effective positive pressure ventilation (PPV) may prevent neonatal deaths. Evaluating heart rate by auscultation may be inaccurate and standard face-mask ventilation (FMV) may be inadequate. NeoTap Life Support (NeoTapLS) is a free-of-charge smartphone app for heart rate recording designed for low-resource settings. The laryngeal mask airway (LMA) is a tube used as an alternative to a face mask. Both of these innovations may be task-shifted to midwives who are on the front-line of neonatal resuscitation in low-resource settings. This thesis reports on investigations into whether these innovations and new strategies can potentially increase adherence to guidelines and thereby reduce neonatal mortality and morbidity. Methods: Two observational studies and a clinical trial were conducted in Sweden and Uganda between 2014 and 2019. We investigated the accuracy and speed of heart rate assessment by NeoTapLS compared to a manikin, a metronome, pulse oximetry and electrocardiography, in simulations and in clinical use. A phase III open-label superiority randomized clinical trial, the NeoSupra Trial, compared LMA with face mask as a primary device for neonatal resuscitation carried out by midwives. The study involved neonates at ≥34 weeks of gestation and/or an expected birth weight of ≥2000 gram, thereby requiring PPV at birth. The primary outcome was a composite of 7-day mortality and moderate-to-severe hypoxic-ischemic encephalopathy, daily evaluated by Thompson scoring through Day 5. Results: Simulation studies showed a high correlation between measured and true values. In the manikin study, 93.5% of the auscultations and 86.3% of the palpations differed by ≤5 beats, mean acquisition time 14.9 vs. 16.3 s. In the metronome study, 77% differed by ≤10. In clinical assessment by doctors of neonates not needing PPV 88% differed by ≤10 and by midwives in neonates needing PPV 48% differed by ≤10, median acquisition time 5 vs. 2.7 s. NeoTapLS showed very good sensitivity and specificity in detecting heart rate