Neonatal resuscitation monitoring: A low-cost video recording setup for quality improvement in the delivery room at the resuscitation table.

Background: The quality of neonatal resuscitation after delivery needs to be improved to reach the Sustainable Development Goals 3.2 (reducing neonatal deaths to <12/1,000 live newborns) by the year 2030. Studies have emphasized the importance of correctly performing the basic steps of resuscitation including stimulation, heart rate assessment, ventilation, and thermal control. Recordings with video cameras have previously been shown to be one way to identify performance practices during neonatal resuscitation. Methods: A description of a low-cost delivery room set up for video recording of neonatal resuscitation. The technical setup includes rechargeable high-definition cameras with two-way audio, NeoBeat heart rate monitors, and the NeoTapAS data collection tools for iPad with direct data export of data for statistical analysis. The setup was field tested at Mulago National Referral Hospital, Kampala, Uganda, and Phu San Hanoi Hospital, Hanoi, Vietnam. Results: The setup provided highly detailed resuscitation video footage including data on procedures and team performance, heart rate monitoring, and clinical assessment of the neonate. The data were analyzed with the free-of-charge NeoTapAS for iPad, which allowed fast and accurate registration of all resuscitative events. All events were automatically registered and exported to R statistical software for further analysis. Conclusions: Video analysis of neonatal resuscitation is an emerging quality assurance tool with the potential to improve neonatal resuscitation outcomes. Our methodology and technical setup are well adapted for low- and lower-middle-income countries settings where improving neonatal resuscitation outcomes is crucial. This delivery room video recording setup also included two-way audio communication that potentially could be implemented in day-to-day practice or used with remote teleconsultants.

Incidence of Intrapartum-Related Events at the Largest Obstetric Hospital in Hanoi, Vietnam: A Retrospective Study.

Every year, 2.4 million neonates die during their first month of life and even more suffer permanent injury. The main causes are intrapartum-related events, prematurity, and infection, with sub-Saharan Africa and southern Asia being the worst affected regions. With a focus on intrapartum-related events, we aimed to assess the neonatal demographic characteristics, clinical management, and outcomes among neonates born at the largest obstetric hospital in Hanoi, Vietnam. This was a retrospective cross-sectional study that included all the inborn neonates in November 2019, which was selected as a representative month. A total of 4554 neonates were born during the study period. Of these, 1.0% (n = 44) were stillbirths, 0.15% (n = 7) died in hospital, 0.61% (n = 28) received positive pressure ventilation at birth, and 0.15% (n = 7) were diagnosed with hypoxic ischemic encephalopathy. A total of 581 (13%) neonates were admitted to the neonatal unit, among which the most common diagnoses were prematurity (37%, n = 217) and infection (15%, n = 89). Except for the intrapartum-related events, our findings are consistent with the previously documented data on neonatal morbidity. The intrapartum-related events, however, were surprisingly low in number even in comparison to high-income countries. Research on the current clinical practice at Phu San Hanoi Hospital may bring further clarity to identify the success factors.

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).

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.

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.).

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.

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.

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 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.