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 <100 bpm. The NeoSupra Trial had a complete follow-up data of 99.2%; the primary outcome occurred in 27.4% in the LMA arm and 24.4% in the FMV arm (adjusted relative risk, 1.16; 95% confidence interval 0.90 to 1.51; P=0.26). Seven-day mortality was 21.7% in LMA and 18.4% in FMV (adjusted relative risk 1.21; 95% confidence interval, 0.90 to 1.63). The proportion of moderate-to-severe HIE was 11.2 vs. 10.1% (adjusted relative risk, 1.27; 95% confidence interval, 0.84 to 1.93). Intervention-related adverse events were few and similar between the arms. Conclusion: NeoTapLS is well adapted in the context it was used for swift and accurate heart rate recording by doctors. Clinical assessment by midwives was less accurate, suggesting that they may benefit from auscultation-focused training. LMA was safe in the hands of midwives but was not superior to a face mask in reducing early neonatal death and moderate-to-severe hypoxic-ischemic encephalopathy. It is suggested further investigations of these innovations and new strategies to explore the possibility of task-shifting its use to midwives in low-resource settings.Doktorgradsavhandlin

Accurate and fast neonatal heart rate assessment with a smartphone‐based application – a manikin study

Aim: This study determined the accuracy and speed of the NeoTapLifeSupport (NeoTapLS), a free smartphone application that aims to assess a neonate's heart rate. Methods: We asked 30 participants with a variety of backgrounds to test the NeoTapLS, which was developed by our own nonprofit organisation Tap4Life, to determine a randomly selected heart rate by auscultation or palpation. The study was carried out in 2014 at Sachs’ Children and Youth Hospital, Sweden, using a Laerdal SimNewB manikin that simulates true values. The NeoTapLS calculates the heart rate based on the user's last three taps on the smartphone screen. Results: A total of 1200 measurements were carried out. A high correlation was found between measured and true values by auscultation (correlation coefficient 0.993) as well as by palpation (correlation coefficient 0.986) with 93.5% of the auscultations and 86.3% of the palpations differing from the true value by five beats or fewer. The mean time to the first estimated heart rate was 14.9 seconds for auscultation and 16.3 seconds for palpation. Conclusion: Heart rates could be accurately and rapidly assessed using the NeoTapLS on a manikin. A globally accessible mobile health system could offer a low‐cost alternative to expensive medical equipment.publishedVersio

Neonatal resuscitation practices in Uganda: a video observational study

Background Neonatal mortality, often due to birth asphyxia, remains stubbornly high in sub-Saharan Africa. Guidelines for neonatal resuscitation, where achieving adequate positive pressure ventilation (PPV) is key, have been implemented in low-resource settings. However, the actual clinical practices of neonatal resuscitation have rarely been examined in these settings. The primary aim of this prospective observational study was to detail the cumulative proportion of time with ventilation during the first minute on the resuscitation table of neonates needing PPV at the Mulago National Referral Hospital in Kampala, Uganda. Methods From November 2015 to January 2016, resuscitations of non-breathing neonates by birth attendants were video-recorded using motion sensor cameras. The resuscitation practices were analysed using the application NeoTapAS and compared between those taking place in the labour ward and those in theatre through Fisher’s exact test and Wilcoxon rank-sum test. Results From 141 recorded resuscitations, 99 were included for analysis. The time to initiation of PPV was 66 (42–102) s overall, and there was minimal PPV during the first minute in both groups with 0 (0–10) s and 0 (0–12) s of PPV, respectively. After initiating PPV the overall duration of interruptions during the first minute was 28 (18–37) s. Majority of interruptions were caused by stimulation (28%), unknown reasons (25%) and suction (22%). Conclusions Our findings show a low adherence to standard resuscitation practices in 2015–2016. This emphasises the need for continuous educational efforts and investments in staff and adequate resources to increase the quality of clinical neonatal resuscitation practices in low-resource settings.publishedVersio

Outcome of infants with 10 min Apgar scores of 0-1 in a low-resource setting

Background In high-resource settings, postponing the interruption of cardiopulmonary resuscitation from 10 to 20 min after birth has been recently suggested, but data from low-resource settings are lacking. We investigated the outcome of newborns with Apgar scores of 0–1 at 10 min of resuscitative efforts in a low-resource setting. Methods This observational substudy from the NeoSupra trial included all 49 late preterm/full-term newborns with Apgar scores of 0–1 at 10 min of resuscitation. The study was carried out at Mulago National Referral Hospital (Kampala, Uganda) between May 2018 and August 2019. Outcome measures were mortality and hypoxic-ischaemic encephalopathy in the first week of life. All resuscitations were video recorded and daily reviewed by trial researchers. Results Median duration of resuscitation was 32 min (IQR 17–37). Advanced resuscitation was provided to 21/49 neonates (43%). Overall, 48 neonates (98%) died within 2 days of life (44 in the delivery room, three on the first day and one on the second day) and one survived at 1 week with severe hypoxic-ischaemic encephalopathy. Conclusion Our study adds information from a low-resource setting to the recent evidence from high-resource settings about prolonging the resuscitation in infants with Apgar scores of 0–1 at 10 min. The vast majority died in the delivery room despite prolonged resuscitative efforts. We confirm that duration of resuscitation should be tailored to the setting, while the focus in low-resource settings should be improving the quality of antenatal and immediately after birth care.acceptedVersio

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 <100 bpm. The NeoSupra Trial had a complete follow-up data of 99.2%; the primary outcome occurred in 27.4% in the LMA arm and 24.4% in the FMV arm (adjusted relative risk, 1.16; 95% confidence interval 0.90 to 1.51; P=0.26). Seven-day mortality was 21.7% in LMA and 18.4% in FMV (adjusted relative risk 1.21; 95% confidence interval, 0.90 to 1.63). The proportion of moderate-to-severe HIE was 11.2 vs. 10.1% (adjusted relative risk, 1.27; 95% confidence interval, 0.84 to 1.93). Intervention-related adverse events were few and similar between the arms. Conclusion: NeoTapLS is well adapted in the context it was used for swift and accurate heart rate recording by doctors. Clinical assessment by midwives was less accurate, suggesting that they may benefit from auscultation-focused training. LMA was safe in the hands of midwives but was not superior to a face mask in reducing early neonatal death and moderate-to-severe hypoxic-ischemic encephalopathy. It is suggested further investigations of these innovations and new strategies to explore the possibility of task-shifting its use to midwives in low-resource settings

Accurate and fast neonatal heart rate assessment with a smartphone‐based application – a manikin study

Aim: This study determined the accuracy and speed of the NeoTapLifeSupport (NeoTapLS), a free smartphone application that aims to assess a neonate's heart rate. Methods: We asked 30 participants with a variety of backgrounds to test the NeoTapLS, which was developed by our own nonprofit organisation Tap4Life, to determine a randomly selected heart rate by auscultation or palpation. The study was carried out in 2014 at Sachs’ Children and Youth Hospital, Sweden, using a Laerdal SimNewB manikin that simulates true values. The NeoTapLS calculates the heart rate based on the user's last three taps on the smartphone screen. Results: A total of 1200 measurements were carried out. A high correlation was found between measured and true values by auscultation (correlation coefficient 0.993) as well as by palpation (correlation coefficient 0.986) with 93.5% of the auscultations and 86.3% of the palpations differing from the true value by five beats or fewer. The mean time to the first estimated heart rate was 14.9 seconds for auscultation and 16.3 seconds for palpation. Conclusion: Heart rates could be accurately and rapidly assessed using the NeoTapLS on a manikin. A globally accessible mobile health system could offer a low‐cost alternative to expensive medical equipment

Neonatal resuscitation practices in Uganda: a video observational study

Background Neonatal mortality, often due to birth asphyxia, remains stubbornly high in sub-Saharan Africa. Guidelines for neonatal resuscitation, where achieving adequate positive pressure ventilation (PPV) is key, have been implemented in low-resource settings. However, the actual clinical practices of neonatal resuscitation have rarely been examined in these settings. The primary aim of this prospective observational study was to detail the cumulative proportion of time with ventilation during the first minute on the resuscitation table of neonates needing PPV at the Mulago National Referral Hospital in Kampala, Uganda. Methods From November 2015 to January 2016, resuscitations of non-breathing neonates by birth attendants were video-recorded using motion sensor cameras. The resuscitation practices were analysed using the application NeoTapAS and compared between those taking place in the labour ward and those in theatre through Fisher’s exact test and Wilcoxon rank-sum test. Results From 141 recorded resuscitations, 99 were included for analysis. The time to initiation of PPV was 66 (42–102) s overall, and there was minimal PPV during the first minute in both groups with 0 (0–10) s and 0 (0–12) s of PPV, respectively. After initiating PPV the overall duration of interruptions during the first minute was 28 (18–37) s. Majority of interruptions were caused by stimulation (28%), unknown reasons (25%) and suction (22%). Conclusions Our findings show a low adherence to standard resuscitation practices in 2015–2016. This emphasises the need for continuous educational efforts and investments in staff and adequate resources to increase the quality of clinical neonatal resuscitation practices in low-resource settings

Outcome of infants with 10 min Apgar scores of 0-1 in a low-resource setting

Background In high-resource settings, postponing the interruption of cardiopulmonary resuscitation from 10 to 20 min after birth has been recently suggested, but data from low-resource settings are lacking. We investigated the outcome of newborns with Apgar scores of 0–1 at 10 min of resuscitative efforts in a low-resource setting. Methods This observational substudy from the NeoSupra trial included all 49 late preterm/full-term newborns with Apgar scores of 0–1 at 10 min of resuscitation. The study was carried out at Mulago National Referral Hospital (Kampala, Uganda) between May 2018 and August 2019. Outcome measures were mortality and hypoxic-ischaemic encephalopathy in the first week of life. All resuscitations were video recorded and daily reviewed by trial researchers. Results Median duration of resuscitation was 32 min (IQR 17–37). Advanced resuscitation was provided to 21/49 neonates (43%). Overall, 48 neonates (98%) died within 2 days of life (44 in the delivery room, three on the first day and one on the second day) and one survived at 1 week with severe hypoxic-ischaemic encephalopathy. Conclusion Our study adds information from a low-resource setting to the recent evidence from high-resource settings about prolonging the resuscitation in infants with Apgar scores of 0–1 at 10 min. The vast majority died in the delivery room despite prolonged resuscitative efforts. We confirm that duration of resuscitation should be tailored to the setting, while the focus in low-resource settings should be improving the quality of antenatal and immediately after birth care

Oxygen saturation after birth in resuscitated neonates in Uganda: A video-based observational study

Background Monitoring of peripheral capillary oxygen saturation (SpO2) during neonatal resuscitation is standard of care in high-resource settings, but seldom performed in low-resource settings. We aimed to measure SpO2 and heart rate during the first 10 min of life in neonates receiving positive pressure ventilation (PPV) according to the Helping Babies Breathe (HBB) protocol and compare results with SpO2 and heart rate targets set by the American Heart Association (AHA). Methods A cross-sectional study was conducted at Mulago National Referral Hospital, Kampala, Uganda, as a substudy of the NeoSupra Trial. SpO2 and heart rate were measured on apnoeic neonates (≥34 weeks) who received PPV according to HBB (room air). Those who remained distressed after PPV received supplemental oxygen (O2). All resuscitations were video recorded and data were extracted by video review at 1 min intervals until 10 min post partum. Data were analysed for all observations and separately for only observations before and during PPV. Results 49 neonates were analysed. Median SpO2 at 5 min (n=39) was 67% (49–88) with 59% of the observations below AHA target of 80%. At 10 min median SpO2 (n=44) was 93% (80–97) and 32% were below AHA target of 85%. When only observations before and during PPV were analysed, median SpO2 at 5 min (n=18) was 52% (34–66) and 83% were below AHA target. At 10 min (n=15), median SpO2 was 72% (57–89) and 67% were below AHA target. Median heart rates were above AHA target of 100 beats/min at all time intervals. Conclusions A high proportion of neonates resuscitated with PPV after birth failed to reach the AHA SpO2 target in this small sample, implying an increased risk of hypoxic-ischaemic encephalopathy. Further studies in low-resource settings are needed to evaluate baseline data and the need for supplemental O2 and optimal SpO2 during PPV.publishedVersio

Smartphone app for neonatal heart rate assessment: an observational study

Background: Heart rate (HR) assessment is crucial in neonatal resuscitation, but pulse oximetry (PO) and electrocardiography (ECG) are rarely accessible in low-resource to middle-resource settings. This study evaluated a free-of-charge smartphone application, NeoTap, which records HR with a screen-tapping method bypassing mental arithmetic calculations. Methods: This observational study was carried out during three time periods between May 2015 and January 2019 in Uganda in three phases. In phase 1, a metronome rate (n=180) was recorded by low-end users (midwives) using NeoTap. In phase 2, HR (n=69) in breathing neonates was recorded by high-end users (paediatricians) using NeoTap versus PO. In phase 3, HR (n=235) in non-breathing neonates was recorded by low-end users using NeoTap versus ECG. Results: In high-end users the mean difference was 3 beats per minute (bpm) higher with NeoTap versus PO (95% agreement limits −14 to 19 bpm), with acquisition time of 5 seconds. In low-end users, the mean difference was 6 bpm lower with NeoTap versus metronome (95% agreement limits −26 to 14 bpm) and 3 bpm higher with NeoTap versus ECG in non-breathing neonates (95% agreement limits −48 to 53 bpm), with acquisition time of 2.7 seconds. The agreement between NeoTap and ECG was good in the HR categories of 60–99 bpm and ≥100 bpm; HR <60 bpm had few measurements (kappa index 0.71, 95% CI 0.63 to 0.79). Conclusion: HR could be accurately and rapidly assessed using a smartphone application in breathing neonates in a low-resource setting. Clinical assessment by low-end users was less accurate with wider CI but still adds clinically important information in non-breathing neonates. The authors suggest low-end users may benefit from auscultation-focused training. More research is needed to evaluate its feasibility in clinical use