A Randomized Trial of Laryngeal Mask Airway in Neonatal Resuscitation.

BACKGROUND: Face-mask ventilation is the most common resuscitation method for birth asphyxia. Ventilation with a cuffless laryngeal mask airway (LMA) has potential advantages over face-mask ventilation during neonatal resuscitation in low-income countries, but whether the use of an LMA reduces mortality and morbidity among neonates with asphyxia is unknown. METHODS: In this phase 3, open-label, superiority trial in Uganda, we randomly assigned neonates who required positive-pressure ventilation to be treated by a midwife with an LMA or with face-mask ventilation. All the neonates had an estimated gestational age of at least 34 weeks, an estimated birth weight of at least 2000 g, or both. The primary outcome was a composite of death within 7 days or admission to the neonatal intensive care unit (NICU) with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization. RESULTS: Complete follow-up data were available for 99.2% of the neonates. A primary outcome event occurred in 154 of 563 neonates (27.4%) in the LMA group and 144 of 591 (24.4%) in the face-mask group (adjusted relative risk, 1.16; 95% confidence interval [CI], 0.90 to 1.51; P = 0.26). Death within 7 days occurred in 21.7% of the neonates in the LMA group and 18.4% of those in the face-mask group (adjusted relative risk, 1.21; 95% CI, 0.90 to 1.63), and admission to the NICU with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization occurred in 11.2% and 10.1%, respectively (adjusted relative risk, 1.27; 95% CI, 0.84 to 1.93). Findings were materially unchanged in a sensitivity analysis in which neonates with missing data were counted as having had a primary outcome event in the LMA group and as not having had such an event in the face-mask group. The frequency of predefined intervention-related adverse events was similar in the two groups. CONCLUSIONS: In neonates with asphyxia, the LMA was safe in the hands of midwives but was not superior to face-mask ventilation with respect to early neonatal death and moderate-to-severe hypoxic-ischemic encephalopathy. (Funded by the Research Council of Norway and the Center for Intervention Science in Maternal and Child Health; NeoSupra ClinicalTrials.gov number, NCT03133572.).

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.

Pilot manikin study showed that a supraglottic airway device improved simulated neonatal ventilation in a low-resource setting.

AIM: We compared the performance of personnel in a low-resource setting when they used the I-gel cuffless neonatal laryngeal mask or a face mask on a neonatal airway management manikin. METHODS: At Mulago Hospital, Uganda, 25 doctors, nurses and midwives involved in neonatal resuscitation were given brief training with the I-gel and face mask. Then, every participant was observed positioning both devices on three consecutive occasions. The success rate and insertion times leading to effective positive pressure ventilation (PPV) were recorded. Participants rated the perceived efficiency of the devices using a five-point Likert scale. RESULTS: The I-gel achieved a 100% success rate on all three occasions, but the face mask was significantly less effective in achieving effective PPV and the failure rates at the first, second and third attempts were 28%, 8% and 20%, respectively. The perceived efficiency of the devices was significantly superior for the I-gel (4.7 ± 0.4) than the face mask (3.3 ± 0.8). CONCLUSION: The I-gel was more effective than the face mask in establishing PPV in the manikin, and user satisfaction was higher. These encouraging manikin data could be a stepping stone for clinical research on the use of the I-gel for neonatal resuscitation in low-resource settings.

Unexpected collapse of healthy newborn infants: risk factors, supervision and hypothermia treatment.

AIM: To determine the occurrence and risk factors of sudden unexpected postnatal collapse (SUPC) in presumably healthy newborn infants. METHODS: All live-born infants during a 30-month period, in five major delivery wards in Stockholm, were screened, and possible cases of SUPC thoroughly investigated. Infants were ≥35 weeks of gestation, had an Apgar score >8 at 10 min and collapsed within 24 h after birth. Maternal, infant, event characteristics and outcome data were collected. RESULTS: Twenty-six cases of SUPC were found among 68 364 live-born infants, an incidence of 38/100 000 live births. Sixteen of these cases of SUPC required resuscitation with ventilation >1 min, and 14 of these remained unexplained (21/100 000). Fifteen of the 26 children were found in a prone position, during skin-to-skin contact, 18 were primipara, and 13 occurred during unsupervised breastfeeding at <2 h of age. Three cases occurred during smart cellular phone use by the mother. Five developed hypoxic-ischaemic encephalopathy (HIE) grade 2, and 4 underwent hypothermia treatment. Twenty-five infants had a favourable neurological outcome. CONCLUSION: SUPC in apparent healthy babies is associated with initial, unsupervised breastfeeding, prone position, primiparity and distractions. Guidelines outlining the appropriate monitoring of newborns and safe early skin-to-skin contact should be implemented.

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. TRIAL REGISTRATION NUMBER: This is a substudy to the trial 'Neonatal Resuscitation with Supraglottic Airway Trial (NeoSupra)'; ClinicalTrials.gov Registry (NCT03133572).

Respiratory monitoring during neonatal resuscitation using a supraglottic airway device vs. a face mask.

OBJECTIVE: To evaluate the respiratory function of asphyxiated infants resuscitated with i-gel supraglottic airway (SGA) vs. face mask (FM) in a low-resource setting. METHODS: In this sub-study from the NeoSupra trial, respiratory function during the first 60 inflations was evaluated in 46 neonates (23 with SGA and 23 with FM) at the Mulago National Referral Hospital, Uganda. The primary outcome was the mask leak (%). The secondary outcomes included inspired (VTi) and expired (VTe) tidal volumes, and heart rate response to ventilation. RESULTS: Median mask leak was 40% (IQR 22-52) with SGA and 39% (IQR 26-62) with FM (p = 0.38). Median VTe was 7.8 ml/kg (IQR 5.6-10.2) with SGA and 7.3 ml/kg (IQR 4.8-11.9) with FM (p = 0.84), while median VTi was 15.4 ml/kg (IQR 11-4-17.6) with SGA and 15.9 ml/kg (IQR 9.0-22.6) with FM (p = 0.68). A shorter time was needed to achieve heart rate > 100 bpm in SGA (median 13 s IQR 9-15) with respect to FM arm (median 61, IQR 33-140) (p = 0.0002). CONCLUSION: Respiratory function was not statistically different between neonates resuscitated with SGA vs. FM. SGA was associated with faster heart rate recovery compared to FM in the subgroup of neonates with bradycardia. Further research is needed to investigate possible advantages of SGA on respiratory function at birth.

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.

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.

Heart rate assessment using NeoTapAdvancedSupport: a simulation study.

BACKGROUND: NeoTapAdvancedSupport (NeoTapAS) is a mobile application, based on a screen tapping method that calculates the heart rate (HR). We aimed to evaluate the accuracy of NeoTapAS in reliably determining HR from auscultation in a high-fidelity simulated newborn resuscitation scenario. METHODS: Paediatric residents assessed HR by auscultation plus NeoTapAS in an asphyxiated term infant scenario and orally communicated the estimated HR. An external observer simultaneously documented the actual HR set in the manikin and the communicated HR. RESULTS: One hundred and sixty HR measurements were recorded. The agreement between communicated and set HR was good (Cohen's kappa 0.80, 95% CI 0.72 to 0.87; Bangdiwala's weighted agreement strength statistic 0.93). Bland-Altman plot showed a mean difference between communicated and set HR values of 1 beats per minute (bpm) (95% agreement limits -9 to 11 bpm). CONCLUSION: NeoTapAS showed a good accuracy in estimating HR and it could be an important resource in settings with limited availability of ECG monitor.

Neonatal resuscitation using a supraglottic airway device for improved mortality and morbidity outcomes in a low-income country: study protocol for a randomized trial.

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.

Neonatal resuscitation using a laryngeal mask airway: a randomised trial in Uganda.

OBJECTIVE: Mortality rates from birth asphyxia in low-income countries remain high. Face mask ventilation (FMV) performed by midwives is the usual method of resuscitating neonates in such settings but may not always be effective. The i-gel is a cuffless laryngeal mask airway (LMA) that could enhance neonatal resuscitation performance. We aimed to compare LMA and face mask (FM) during neonatal resuscitation in a low-resource setting. SETTING: Mulago National Referral Hospital, Kampala, Uganda. DESIGN: This prospective randomised clinical trial was conducted at the labour ward operating theatre. After a brief training on LMA and FM use, infants with a birth weight >2000 g and requiring positive pressure ventilation at birth were randomised to resuscitation by LMA or FM. Resuscitations were video recorded. MAIN OUTCOME MEASURES: Time to spontaneous breathing. RESULTS: Forty-nine (24 in the LMA and 25 in the FM arm) out of 50 enrolled patients were analysed. Baseline characteristics were comparable between the two arms. Time to spontaneous breathing was shorter in LMA arm than in FM arm (mean 153 s (SD±59) vs 216 s (SD±92)). All resuscitations were effective in LMA arm, whereas 11 patients receiving FM were converted to LMA because response to FMV was unsatisfactory. There were no adverse effects. CONCLUSION: A cuffless LMA was more effective than FM in reducing time to spontaneous breathing. LMA seems to be safe and effective in clinical practice after a short training programme. Its potential benefits on long-term outcomes need to be assessed in a larger trial. CLINICAL TRIAL REGISTRY: This trial was registered in https://clinicaltrials.gov, with registration number NCT02042118.