SaferBirths bundle of care protocol: a stepped-wedge cluster implementation project in 30 public health-facilities in five regions, Tanzania.

BACKGROUND: The burden of stillbirth, neonatal and maternal deaths are unacceptably high in low- and middle-income countries, especially around the time of birth. There are scarce resources and/or support implementation of evidence-based training programs. SaferBirths Bundle of Care is a well-proven package of innovative tools coupled with data-driven on-the-job training aimed at reducing perinatal and maternal deaths. The aim of this project is to determine the effect of scaling up the bundle on improving quality of intrapartum care and perinatal survival. METHODS: The project will follow a stepped-wedge cluster implementation design with well-established infrastructures for data collection, management, and analysis in 30 public health facilities in regions in Tanzania. Healthcare workers from selected health facilities will be trained in basic neonatal resuscitation, essential newborn care and essential maternal care. Foetal heart rate monitors (Moyo), neonatal heart rate monitors (NeoBeat) and skills trainers (NeoNatalie Live) will be introduced in the health facilities to facilitate timely identification of foetal distress during labour and improve neonatal resuscitation, respectively. Heart rate signal-data will be automatically collected by Moyo and NeoBeat, and newborn resuscitation training by NeoNatalie Live. Given an average of 4000 baby-mother pairs per year per health facility giving an estimate of 240,000 baby-mother pairs for a 2-years duration, 25% reduction in perinatal mortality at a two-sided significance level of 5%, intracluster correlation coefficient (ICC) to be 0.0013, the study power stands at 0.99. DISCUSSION: Previous reports from small-scale Safer Births Bundle implementation studies show satisfactory uptake of interventions with significant improvements in quality of care and lives saved. Better equipped and trained birth attendants are more confident and skilled in providing care. Additionally, local data-driven feedback has shown to drive continuous quality of care improvement initiatives, which is essential to increase perinatal and maternal survival. Strengths of this research project include integration of innovative tools with existing national guidelines, local data-driven decision-making and training. Limitations include the stepwise cluster implementation design that may lead to contamination of the intervention, and/or inability to address the shortage of healthcare workers and medical supplies beyond the project scope. TRIAL REGISTRATION: Name of Trial Registry: ISRCTN Registry. TRIAL REGISTRATION NUMBER: ISRCTN30541755 . Date of Registration: 12/10/2020. Type of registration: Prospectively Registered.

Fetal to Neonatal Heart Rate Transition during Normal Vaginal Deliveries: A Prospective Observational Study.

Documentation of fetal to neonatal heart rate (HR) transition is limited. The aim of the current study was to describe HR changes from one hour before to one hour after normal vaginal deliveries. We conducted a prospective observational cohort study in Tanzania from 1 October 2020 to 30 August 2021, including normal vaginal deliveries with normal neonatal outcomes. HR was continuously recorded from one hour before to one hour after delivery, using the Moyo fetal HR meter, NeoBeat newborn HR meter, and the Liveborn Application for data storage. The median, 25th, and 75th HR percentiles were constructed. Overall, 305 deliveries were included. Median (interquartile range; IQR) gestational age was 39 (38-40) weeks and birthweight was 3200 (3000-3500) grams. HR decreased slightly during the last 60 min before delivery from 136 (123,145) to 132 (112,143) beats/minute. After delivery, HR increased within one minute to 168 (143,183) beats/min, before decreasing to around 136 (127,149) beats/min at 60 min after delivery. The drop in HR in the last hour of delivery reflects strong contractions and pushing. The rapid increase in initial neonatal HR reflects an effort to establish spontaneous breathing.

Neurodevelopmental Outcome at 6 Months Following Neonatal Resuscitation in Rural Tanzania.

Early bag-mask ventilation (BMV) administered to non-breathing neonates at birth in the presence of birth asphyxia (interruption of placental blood flow) has reduced neonatal mortality by up to 50% in low- and middle-income countries. The neurodevelopmental outcome of neonates receiving BMV remains unknown. Using the Malawi Developmental Assessment Tool (MDAT), infants who received BMV at birth were assessed at 6 months, evaluating gross motor, fine motor, language and social skills. A healthy cohort with no birth complications was assessed with the same tool for comparison. Mean age-adjusted MDAT z-scores were not significantly different between the groups. The number of children having developmental delay defined as a z-score ≤ -2 was significantly higher in the resuscitated cohort for the fine motor and language domain and overall MDAT z-score. The prevalence of clinical seizures post discharge was significantly higher in the resuscitated group and was associated with neurodevelopmental delay. Infants with developmental delay or seizures were more likely to have a 5 min Apgar < 7 and a longer duration of BMV. Most children receiving BMV at birth are developing normally at 6 months. Still, there are some children with impaired development among resuscitated children, representing a subgroup of children who may have suffered more severe asphyxia.

Delivery Room ST Segment Analysis to Predict Short Term Outcomes in Near-Term and Term Newborns.

BACKGROUND: ST-segment changes to the fetal electrocardiogram (ECG) may indicate fetal acidosis. No large-scale characterization of ECG morphology immediately after birth has been performed, but ECG is used for heart rate (HR) assessment. We aimed to investigate ECG morphology immediately after birth in asphyxiated infants, using one-lead dry-electrode ECG developed for HR measurement. METHODS: Observational study in Tanzania, between 2013-2018. Near-term and term infants that received bag-mask ventilation (BMV), and healthy controls, were monitored with one-lead dry-electrode ECG with a non-diagnostic bandwidth. ECGs were classified as normal, with ST-elevations or other ST-segment abnormalities including a biphasic ST-segment. We analyzed ECG morphology in relation to perinatal variables or short-term outcomes. RESULTS: A total of 494 resuscitated and 25 healthy infants were included. ST-elevations were commonly seen both in healthy infants (7/25; 28%) and resuscitated (320/494; 65%) infants. The apparent ST-elevations were not associated with perinatal variables or short-term outcomes. Among the 32 (6.4%) resuscitated infants with "other ST-segment abnormalities", duration of BMV was longer, 1-min Apgar score lower and normal outcomes less frequent than in the resuscitated infants with normal ECG or ST-elevations. CONCLUSIONS: ST-segment elevation was commonly seen and not associated with negative outcomes when using one-lead dry-electrode ECG. Other ST-segment abnormalities were associated with prolonged BMV and worse outcome. ECG with appropriate bandwidth and automated analysis may potentially in the future aid in the identification of severely asphyxiated infants.

Heart rate detection properties of dry-electrode ECG compared to conventional 3-lead gel-electrode ECG in newborns.

OBJECTIVE: To compare the accuracy of heart rate detection properties of a novel, wireless, dry-electrode electrocardiogram (ECG) device, NeoBeat®, to that of a conventional 3-lead gel-electrode ECG monitor (PropaqM®) in newborns. RESULTS: The study population had a mean gestational age of 39 weeks and 2 days (1.5 weeks) and birth weight 3528 g (668 g). There were 950 heart rate notations from each device, but heart rate was absent from the reference monitor in 14 of these data points, leaving 936 data pairs to compare. The mean (SD) difference when comparing NeoBeat to the reference monitor was -0.25 (9.91) beats per minute (bpm) (p = 0.44). There was a deviation of more than 10 bpm in 7.4% of the data pairs, which primarily (78%) was attributed to ECG signal disturbance, and secondly (22%) due to algorithm differences between the devices. Excluding these outliers, the correlation was equally consistent (r2 = 0.96) in the full range of heart rate captured measurements with a mean difference of - 0.16 (3.09) bpm. The mean difference was less than 1 bpm regardless of whether outliers were included or not.

Distribution of heart rate and responses to resuscitation among 1237 apnoeic newborns at birth.

AIM OF THE STUDY: Describe the distribution of the first recorded heart rate (HR) in apnoeic term/near-term newborns, HR responses to basic resuscitation (no intubation, chest compressions and/or medication), and relationship to 24-h outcomes. We also document patient characteristics and care provider behaviour stratified by first HR. METHODS: Descriptive study from July 2013 through June 2018 at Haydom Hospital in Tanzania. All deliveries were observed by assistants recording data. Bag-mask ventilation and ECG data were recorded by resuscitation monitors. Newborns with ≥5 ventilations and ECG signal-data were included. RESULTS: 1237 term/near-term newborns with median (25th, 75th percentiles) gestation 38 (37, 40) weeks and birth weight 3140 (2750, 3500) grams fulfilled inclusion criteria. The first HR, measured median 102 (73, 144) s after birth following drying/stimulation, was distributed into two peaks with centres around 60 and 165 bpm, 51% were ≥100 bpm. After ventilation, the HR distribution shifted to a single-peak, with median 161 bpm. At least one low-high HR transition crossing 100 bpm was noted in 44% of newborns. The HR increase occurred over median 9.2 (6.2, 13) s, was 60 (43, 77) bpm, and 86% followed a ventilation sequence of 23 (16, 34) s duration. 72% of the newborns with first HR < 60 bpm survived following ventilations only. Both first and final HR were significantly related to 24-h outcomes. CONCLUSIONS: The first recorded HR was distributed into two peaks on each side of 100 bpm. Ventilation increased HR in most newborns. Lower first and final HR were related to gradually more adverse 24-h outcomes.

Increased perinatal survival and improved ventilation skills over a five-year period: An observational study.

BACKGROUND AND AIM: The Helping Babies Breathe program gave major reductions in perinatal mortality in Tanzania from 2009 to 2012. We aimed to study whether this effect was sustained, and whether resuscitation skills changed with continued frequent training. METHODS: We analysed prospective data covering all births (n = 19,571) at Haydom Lutheran Hospital in Tanzania from July 2013 -June 2018. Resuscitation training was continued during this period. All deliveries were monitored by an observer recording the timing of events and resuscitation interventions. Heart rate was recorded by dry-electrode ECG and bag-mask-ventilation by sensors attached to the resuscitator device. We analyzed changes over time in outcomes, use of resuscitation interventions and performance of resuscitation using binary regression models with the log-link function to obtain adjusted relative risks. RESULTS: With introduction of user fees for deliveries since 2014, the number of deliveries decreased by 30% from start to the end of the five-year period. An increase in low heart rate at birth and need for bag-mask-ventilation indicate a gradual selection of more vulnerable newborns delivered in the hospital over time. Despite this selection, newborn deaths <24 hours did not change significantly and was maintained at an average of 8.8/1000 live births. The annual reductions in relative risk for perinatal death adjusted for vulnerability factors was 0.84 (95%CI 0.76-0.94). During the five-year period, longer duration of bag-mask ventilation sequences without interruption was observed. Delivered tidal volumes were increased and mask leak was decreased during ventilation. The time to initiation or total duration of ventilation did not change significantly. CONCLUSION: The reduction in 24-hour newborn mortality after introduction of Helping Babies Breathe was maintained, and a further decrease over the five-year period was evident when analyses were adjusted for vulnerability of the newborns. Perinatal survival and performance of ventilation were significantly improved.

Positive End-Expiratory Pressure in Newborn Resuscitation Around Term: A Randomized Controlled Trial.

BACKGROUND: International guidelines for resuscitation recommend using positive end-expiratory pressure (PEEP) during ventilation of preterm newborns. Reliable PEEP-valves for self-inflating bags have been lacking, and effects of PEEP during resuscitation of term newborns are insufficiently studied. The objective was to determine if adding a new PEEP valve to the bag-mask during resuscitation of term and near-term newborns could improve heart rate response. METHODS: This randomized controlled trial was performed at Haydom Lutheran Hospital in Tanzania (September 2016 to June 2018). Helping Babies Breathe-trained midwives performed newborn resuscitation using self-inflating bags with or without a new, integrated PEEP valve. All live-born newborns who received bag-mask ventilation at birth were eligible. Heart rate response measured by ECG was the primary outcome, and clinical outcome and ventilation data were recorded. RESULTS: Among 417 included newborns (median birth weight 3200 g), 206 were ventilated without and 211 with PEEP. We found no difference in heart rate response. Median (interquartile range) measured PEEP in the PEEP group was 4.7 (2.0-5.6) millibar. The PEEP group received lower tidal volumes (4.9 [1.9-8.2] vs 6.3 [3.9-10.5] mL/kg; P = .02) and had borderline lower expired CO2 (2.9 [1.5-4.3] vs 3.3 [1.9-5.0] %; P = .05). Twenty four-hour mortality was 9% in both groups. CONCLUSIONS: We found no evidence for improved heart rate response during bag-mask ventilation with PEEP compared with no PEEP. The PEEP valve delivered a median PEEP within the intended range. The findings do not support routine use of PEEP during resuscitation of newborns around term.

Predictors for expired CO2 in neonatal bag-mask ventilation at birth: observational study.

BACKGROUND: Expired carbon dioxide (ECO2) indicates degree of lung aeration immediately after birth. Favourable ventilation techniques may be associated with higher ECO2 and a faster increase. Clinical condition will however also affect measured values. The aim of this study was to explore the relative impact of ventilation factors and clinical factors on ECO2 during bag-mask ventilation of near-term newborns. METHODS: Observational study performed in a Tanzanian rural hospital. Side-stream measures of ECO2, ventilation data, heart rate and clinical information were recorded in 434 bag-mask ventilated newborns with initial heart rate <120 beats per minute. We studied ECO2 by clinical factors (birth weight, Apgar scores and initial heart rate) and ventilation factors (expired tidal volume, ventilation frequency, mask leak and inflation pressure) in random intercept models and Cox regression for time to ECO2 >2%. RESULTS: ECO2 rose non-linearly with increasing expired tidal volume up to >10 mL/kg, and sufficient tidal volume was critical for the time to reach ECO2 >2%. Ventilation frequency around 30/min was associated with the highest ECO2. Higher birth weight, Apgar scores and initial heart rate were weak, but significant predictors for higher ECO2. Ventilation factors explained 31% of the variation in ECO2 compared with 11% for clinical factors. CONCLUSIONS: Our findings indicate that higher tidal volumes than currently recommended and a low ventilation frequency around 30/min are associated with improved lung aeration during newborn resuscitation. Low ECO2 may be used to identify unfavourable ventilation technique. Clinical factors are also associated with persistently low ECO2 and must be accounted for in the interpretation.

Scaling Up Safer Birth Bundle Through Quality Improvement in Nepal (SUSTAIN)-a stepped wedge cluster randomized controlled trial in public hospitals.

BACKGROUND: Each year, 2.2 million intrapartum-related deaths (intrapartum stillbirths and first day neonatal deaths) occur worldwide with 99% of them taking place in low- and middle-income countries. Despite the accelerated increase in the proportion of deliveries taking place in health facilities in these settings, the stillborn and neonatal mortality rates have not reduced proportionately. Poor quality of care in health facilities is attributed to two-thirds of these deaths. Improving quality of care during the intrapartum period needs investments in evidence-based interventions. We aim to evaluate the quality improvement package-Scaling Up Safer Bundle Through Quality Improvement in Nepal (SUSTAIN)-on intrapartum care and intrapartum-related mortality in public hospitals of Nepal. METHODS: We will conduct a stepped wedge cluster randomized controlled trial in eight public hospitals with each having least 3000 deliveries a year. Each hospital will represent a cluster with an intervention transition period of 2 months in each. With a level of significance of 95%, the statistical power of 90% and an intra-cluster correlation of 0.00015, a study period of 19 months should detect at least a 15% change in intrapartum-related mortality. Quality improvement training, mentoring, systematic feedback, and a continuous improvement cycle will be instituted based on bottleneck analyses in each hospital. All concerned health workers will be trained on standard basic neonatal resuscitation and essential newborn care. Portable fetal heart monitors (Moyo®) and neonatal heart rate monitors (Neobeat®) will be introduced in the hospitals to identify fetal distress during labor and to improve neonatal resuscitation. Independent research teams will collect data in each hospital on intervention inputs, processes, and outcomes by reviewing records and carrying out observations and interviews. The dose-response effect will be evaluated through process evaluations. DISCUSSION: With the global momentum to improve quality of intrapartum care, better understanding of QI package within a health facility context is important. The proposed package is based on experiences from a similar previous scale-up trial carried out in Nepal. The proposed evaluation will provide evidence on QI package and technology for implementation and scale up in similar settings. TRIAL REGISTRATION NUMBER: ISRCTN16741720 . Registered on 2 March 2019.

Fresh stillborn and severely asphyxiated neonates share a common hypoxic-ischemic pathway.

OBJECTIVE: To characterize, among non-breathing flaccid neonates at delivery, immediate heartrate and responses to ventilation in relation to the clinical diagnosis of fresh stillbirth (FSB) or early neonatal death (END) within 24 hours. METHODS: The present cross-sectional study included all deliveries at Haydom Hospital in rural Tanzania between July 1, 2013, and July 31, 2016. Ventilation parameters and heartrate were recorded by monitors with ventilation and dry-electrocardiography sensors. Perinatal characteristics were recorded on data forms by trained research assistants. RESULTS: Among 12 789 neonates delivered, 915 were ventilated; among ventilated neonates, there were 53 (6%) FSBs and 64 (7%) ENDs. Electrocardiography was used in 46 FSBs and 55 ENDs, and these neonates were included in a subanalysis. Initial heartrate was detected in 27 (59%) of 46 FSBs and 52 (95%) of 55 ENDs, and was lower in FSBs (52 ± 19 vs 76 ± 37 bpm; P=0.003). More ENDs responded to ventilation (53% vs 9%; P<0.001), with heartrate increasing above 100 bpm. Heartrate at ventilation discontinuation was higher among ENDs (115 ± 49 vs 52 ± 33 bpm; P<0.001). CONCLUSION: Progression to FSB or END after intrapartum hypoxia/anoxia is probably part of the same circulatory end-process. Distinguishing FSB from severely asphyxiated newborns is clinically difficult and probably influences estimated global perinatal mortality rates.

Feasibility of a prototype newborn resuscitation monitor to study transition at birth, measuring heart rate and ventilator parameters, an animal experimental study.

BACKGROUND: Every year, an estimated 10 million babies are born, non-breathing and in need of resuscitation. Advances in management have been made over the past decades, however, approximately 700.000 yearly deaths result from this global problem. A prototype newborn resuscitation monitor (NRM) (Laerdal Global Health, Stavanger, Norway) has been developed with the purpose of studying newborn resuscitation. The monitor has the ability to continuously display HR using dry electrode ECG technology, to measure tidal volume, pressure and end tidal CO2, and to store the results for later analysis. Such monitor could enhance the care providers performance, and hence survival of neonates, by displaying the quality and response of the given care. The aim of this preclinical study was to describe the abilities of the NRM to measure ventilation and heart rate parameters against pathophysiological responses to different induced conditions in a piglet i.e. increased deadspace, pressure and washout of surfactant. METHODS: Piglets were chosen for the study, as they have tidal volumes of approximately 6 ml/kg, resembling the human neonate. Five piglets were anesthetized and intubated before starting positive pressure ventilation (PPV). The dry electrode ECG sensor of the NRM was placed over the abdomen, and experiments performed: (1) inducing different ventilation scenarios and (2) lavage of surfactant. RESULTS: The NRM was capable of continuously displaying HR and detecting inflicted changes in ventilation and compliance of piglets. It could measure inflated and exhaled volume, the pressure of the ventilations and also the end tidal CO2. CONCLUSIONS: The NRM provides objective feedback in anesthetized animals, and may be used in clinical studies and hopefully generate new knowledge on neonatal transition and resuscitation. The monitor may be further developed for use in both low and high-resource settings.

Automatic Detection and Parameterization of Manual Bag-Mask Ventilation on Newborns.

OBJECTIVES: Birth asphyxia is a condition where a fetus suffers from lack of oxygen during birth. Intervention by manual ventilation should start within one minute after birth. Bag-mask resuscitators are commonly used in situations where ventilation is provided by a single health care worker. Due to a high complexity of interactions between physiological conditions of the newborns and the clinical treatment, the recommendations for bag-mask ventilation of infants remains controversial. The purpose of this paper is to illustrate the processing and parameterization of ventilation signals recorded from the Laerdal newborn resuscitation monitor into meaningful data. METHODS: Basic signal processing approaches are applied on various signal channels (airway pressure, flow, CO 2, and ECG) to detect events related to ventilation activities. RESULTS: Different types of events are detected and parameterized to describe the characteristics of ventilation procedure. CONCLUSIONS: Efficient detection algorithms as well as parameterization of ventilation events could be useful for retrospective analysis of resuscitation data, for example, by finding the association between different ventilation parameters and positive responses of newborns. SIGNIFICANCE: Information about ventilation events and ventilation parameters could potentially be useful during a resuscitation situation by giving immediate feedback to the health care provider.

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

Normal Newborn Heart Rate in the First Five Minutes of Life Assessed by Dry-Electrode Electrocardiography.

BACKGROUND: There is limited evidence regarding the heart rate (HR) during the first minutes of life. Nonetheless, resuscitative actions within the first minute are partly guided by different HR levels. The advent of an electrocardiographic (ECG) HR sensor with early HR detection has provided the opportunity to study changes immediately following delivery. OBJECTIVE: The objectives were to determine immediately following delivery: (i) the time to achievement of reliable ECG signals using dry electrodes, (ii) changes in HR, and (iii) the influence of the onset of breathing and cord clamping on the HR. METHODS: Healthy term neonates were randomly included between July and October 2013. The HR was recorded by the ECG sensor, placed over the abdomen immediately after birth. RESULTS: Fifty-five newborns were included. The median time from birth to placement of the HR sensor was 3 s (quartiles: 2 and 5), and the median time to the start of breathing was 6 s (quartiles: 2 and 15). The HR was around 120 beats/min (bpm) in the first seconds of life. As determined via breakpoint analysis, the HR increased by 1 beat in the first 40 s to 149 ± 33 bpm, followed by a moderate increase until 130 s and stabilization thereafter. After the onset of breathing, the HR decreased for 10 s and then increased. Minimal HR changes were observed after cord clamping. CONCLUSION: A dry-electrode ECG sensor detected reliable ECG signals almost immediately after birth. The normal HR increased significantly in spontaneously breathing infants during the first minute, influenced by the onset of breathing. Delayed cord clamping had a minimal impact on the HR, likely reflecting an earlier onset of breathing.

Neonatal outcome following cord clamping after onset of spontaneous respiration.

BACKGROUND AND OBJECTIVE: Evolving data indicate that cord clamping (CC) beyond 30 to 60 seconds after birth is of benefit for all infants. Recent experimental data demonstrated that ventilation before CC improved cardiovascular stability by increasing pulmonary blood flow. The objective was to describe the relationship between time to CC, onset of spontaneous respirations (SR), and 24-hour neonatal outcome. METHODS: In a rural Tanzanian hospital, trained research assistants, working in shifts, have observed every delivery (November 2009-February 2013) and recorded data including time interval from birth to SR and CC, fetal heart rate, perinatal characteristics and outcome (normal, death, admission). RESULTS: Of 15,563 infants born, 12,780 (84.3%) initiated SR at 10.8 ± 16.7 seconds, and CC occurred at 63 ± 45 seconds after birth. Outcomes included 12,730 (99.7%) normal, 31 deaths, and 19 admitted; 11,967 were of birth weight (BW) ≥2500 g and 813 <2500 g. By logistic modeling, the risk of death/admission was consistently higher if CC occurred before SR. Infants of BW <2500 g were more likely to die or be admitted. The risk of death/admission decreased by 20% for every 10-second delay in CC after SR; this risk declined at the same rate in both BW groups. CONCLUSIONS: Healthy self-breathing neonates are more likely to die or be admitted if CC occurs before or immediately after onset of SR. These clinical observations support the experimental findings of a smoother cardiovascular transition when CC is performed after initiation of ventilation.