Availability of active therapeutic hypothermia at birth for neonatal hypoxic ischaemic encephalopathy: a UK population study from 2011 to 2018.

OBJECTIVE: Therapeutic hypothermia (TH) commenced soon after birth for neonatal hypoxic ischaemic encephalopathy (HIE) improves survival and reduces neurodisability. Availability of active TH at the place of birth (Immediate-TH) in the UK is unknown. DESIGN: Population-based observational study. SETTING: UK maternity centres. PATIENTS: 5 975 056 births from 2011 to 2018. INTERVENTION METHODS: For each maternity centre, the year active Immediate-TH was available and the annual birth rates were established. Admission temperatures of infants with HIE transferred from non-tertiary centres with and without Immediate-TH were compared. MAIN OUTCOME MEASURES: Quantify the annual number of births with access to Immediate-TH. Secondary outcomes included temporal changes in Immediate-TH and admission temperatures for infants requiring transfer to tertiary centres. RESULTS: In UK maternity centres, 75 of 194 (38.7%) provided Immediate-TH in 2011 rising to 95 of 192 (49.5%, p=0.003) in 2018 with marked regional variations. In 2011, 394 842 (51.2%) of 771 176 births had no access to Immediate-TH compared with 276 258 (39.3%) of 702 794 births in 2018 (p<0.001). More infants with HIE arrived in the therapeutic temperature range (76.5% vs 67.3%; OR 1.58, 95% CI 1.25 to 2.0, p<0.001) with less overcooling (10.6% vs 14.3%; OR 0.71, 95% CI 0.51 to 0.98, p=0.036) from centres with Immediate-TH compared with those without. CONCLUSIONS: Availability of active Immediate-TH has slowly increased although many newborns still have no access and rely on transport team arrival to commence active TH. This is associated with delayed optimal hypothermic management. Provision of Immediate-TH across all units, with appropriate training and support, could improve care of infants with HIE.

Feasibility of a Novel ECG Electrode Placement Method in Newborn Infants.

BACKGROUND: International newborn resuscitation guidelines recommend electrocardiogram (ECG) heart rate (HR) monitoring at birth. We evaluated the application time of pre-set ECG electrodes fixed to a polyethene patch allowing adhesive-free attachment to the wet skin of the newborn chest. OBJECTIVES: Using a three-electrode pre-set ECG patch configuration, application success was calculated using video analysis and measured at three time points, the time to (1) apply electrodes; (2) detect recognizable QRS complexes after application; and (3) display a HR after application. METHOD: A prospective observational study in two UK tertiary maternity units was undertaken with 71 newborns including 23 who required resuscitation. RESULTS: The median (IQR) time for ECG patch application was 8 (6-10) seconds, detection of recognizable QRS complexes 8 (2-12) seconds, and time to output HR was 23 (15-37) seconds. CONCLUSION: Pre-set ECG chest electrodes allow rapid HR information at birth without electrode detachment or compromising skin integrity.

Temporal trends of in utero and early postnatal transfer of extremely preterm infants between 2011 and 2016: a UK population study.

OBJECTIVE: Early postnatal transfer (PNT) of extremely preterm infants is associated with adverse outcomes compared with in utero transfer (IUT). We aimed to explore recent national trends of IUT and early PNT. DESIGN: Observational cohort study using the National Neonatal Research Database. SETTING: Neonatal units in England, Scotland and Wales. PATIENTS: Extremely preterm infants 23+0-27+6 weeks' gestation admitted for neonatal care from 2011 to 2016. MAIN OUTCOME: The incidence of IUT or PNT within 72 hours of life. Secondary outcomes included mortality, hospital transfer level between centres and temporal changes across two equal epochs, 2011-2013 (epoch 1 (Ep1)) and 2014-2016 (epoch 2 (Ep2)). RESULTS: 14 719 infants were included (Ep1=7363 and Ep2=7256); 4005 (27%) underwent IUT; and 3042 (20.7%) had PNT. IUTs decreased significantly between epochs from 28.3% (Ep1=2089) to 26.0% (Ep2=1916) (OR 0.90, 95% CI 0.84 to 0.97, p<0.01). Conversely, PNTs increased from 19.8% (Ep1=1416) to 21.5% (Ep2=1581) (OR 1.11, 95% CI 1.02 to 1.20, p=0.01). PNTs between intensive care centres increased from 8.1% (Ep1=119) to 10.2% (Ep2=161, p=0.05). Mortality decreased from 21.6% (Ep1=1592) to 19.3% (Ep2=1421) (OR 0.90, 95% CI 0.83 to 0.97, p=0.01). Survival to 90 days of age was significantly lower in infants undergoing PNT compared with IUT (HR 1.31, 95% CI 1.18 to 1.46), with the greatest differences observed in infants <25 weeks' gestational age. CONCLUSION: In the UK, IUT of extremely preterm infants has significantly decreased over the study period with a parallel increase in early PNT. Strategies to reverse these trends, improve IUT pathways and optimise antenatal steroid use could significantly improve survival and reduce brain injury for these high-risk infants.

Outcomes of neonatal hypoxic-ischaemic encephalopathy in centres with and without active therapeutic hypothermia: a nationwide propensity score-matched analysis.

OBJECTIVE: Therapeutic hypothermia (TH) for neonatal hypoxic-ischaemic encephalopathy (HIE), delivered mainly in tertiary cooling centres (CCs), reduces mortality and neurodisability. It is unknown if birth in a non-cooling centre (non-CC), without active TH, impacts short-term outcomes. DESIGN: Retrospective cohort study using National Neonatal Research Database and propensity score-matching. SETTING: UK neonatal units. PATIENTS: Infants ≥36 weeks gestational age with moderate or severe HIE admitted 2011-2016. INTERVENTIONS: Birth in non-CC compared with CC. MAIN OUTCOME MEASURES: Primary outcome was survival to discharge without recorded seizures. Secondary outcomes were recorded seizures, mortality and temperature on arrival at CCs following transfer. RESULTS: 5059 infants were included with 2364 (46.7%) born in non-CCs. Birth in a CC was associated with improved survival without seizures (35.1% vs 31.8%; OR 1.15, 95% CI 1.02 to 1.31; p=0.02), fewer seizures (60.7% vs 64.6%; OR 0.84, 95% CI 0.75 to 0.95, p=0.007) and similar mortality (15.8% vs 14.4%; OR 1.11, 95% CI 0.93 to 1.31, p=0.20) compared with birth in a non-CC. Matched infants from level 2 centres only had similar results, and birth in CCs was associated with greater seizure-free survival compared with non-CCs. Following transfer from a non-CC to a CC (n=2027), 1362 (67.1%) infants arrived with a recorded optimal therapeutic temperature but only 259 (12.7%) of these arrived within 6 hours of birth. CONCLUSIONS: Almost half of UK infants with HIE were born in a non-CC, which was associated with suboptimal hypothermic treatment and reduced seizure-free survival. Provision of active TH in non-CC hospitals prior to upward transfer warrants consideration.

Trends in the incidence and management of hypoxic-ischaemic encephalopathy in the therapeutic hypothermia era: a national population study.

OBJECTIVE: Hypoxic-ischaemic encephalopathy (HIE) remains a leading cause of neonatal mortality and neurodisability. We aimed to determine the incidence of HIE and management patterns against national guidelines. DESIGN: Retrospective cohort study using the National Neonatal Research Database. SETTING: Neonatal units in England and Wales. PATIENTS: Infants 34-42 weeks gestational age (GA) with a recorded diagnosis of HIE. MAIN OUTCOMES: Incidence of HIE, mortality and treatment with therapeutic hypothermia (TH) were the main outcomes. Temporal changes were compared across two epochs (2011-2013 and 2014-2016). RESULTS: Among 407 462 infants admitted for neonatal care, 12 195 were diagnosed with HIE. 8166 infants ≥36 weeks GA had moderate/severe HIE, 62.1% (n=5069) underwent TH and mortality was 9.3% (n=762). Of infants with mild HIE (n=3394), 30.3% (n=1027) underwent TH and 6 died. In late preterm infants (34-35 weeks GA) with HIE (n=635, 5.2%), 33.1% (n=210) received TH and 13.1% (n=83) died. Between epochs (2011-2013 vs 2014-2016), mortality decreased for infants ≥36 weeks GA with moderate/severe HIE (17.5% vs 12.3%; OR 0.69, 95% CI 0.59 to 0.81, p<0.001). Treatment with TH increased significantly between epochs in infants with mild HIE (24.9% vs 35.8%, p<0.001) and those born late preterm (34.3% vs 46.6%, p=0.002). CONCLUSIONS: Mortality of infants ≥36 weeks GA with moderate/severe HIE has reduced over time, although many infants diagnosed with moderate/severe HIE do not undergo TH. Increasingly, mild HIE and late preterm infants with HIE are undergoing TH, where the evidence base is lacking, highlighting the need for prospective studies to evaluate safety and efficacy in these populations.

Accurate neonatal heart rate monitoring using a new wireless, cap mounted device.

AIM: A device for newborn heart rate (HR) monitoring at birth that is compatible with delayed cord clamping and minimises hypothermia risk could have advantages over current approaches. We evaluated a wireless, cap mounted device (fhPPG) for monitoring neonatal HR. METHODS: A total of 52 infants on the neonatal intensive care unit (NICU) and immediately following birth by elective caesarean section (ECS) were recruited. HR was monitored by electrocardiogram (ECG), pulse oximetry (PO) and the fhPPG device. Success rate, accuracy and time to output HR were compared with ECG as the gold standard. Standardised simulated data assessed the fhPPG algorithm accuracy. RESULTS: Compared to ECG HR, the median bias (and 95% limits of agreement) for the NICU was fhPPG -0.6 (-5.6, 4.9) vs PO -0.3 (-6.3, 6.2) bpm, and ECS phase fhPPG -0.5 (-8.7, 7.7) vs PO -0.1 (-7.6, 7.1) bpm. In both settings, fhPPG and PO correlated with paired ECG HRs (both R2  = 0.89). The fhPPG HR algorithm during simulations demonstrated a near-linear correlation (n = 1266, R2  = 0.99). CONCLUSION: Monitoring infants in the NICU and following ECS using a wireless, cap mounted device provides accurate HR measurements. This alternative approach could confer advantages compared with current methods of HR assessment and warrants further evaluation at birth.

Neurocritical care of high-risk infants during inter-hospital transport.

The centralisation of neonatal intensive care in recent years has improved mortality, particularly of extremely preterm infants, but similar improvements in morbidity, such as neurodevelopmental impairment, have not been seen. Integral to the success of centralisation are specialised neonatal transport teams who provide intensive care prior to and during retrieval of high-risk neonates when in-utero transfer has not been possible. Neonatal retrieval aims to stabilise the clinical condition and then transfer the neonate during a high-risk period for patient. Transport introduces the hazards of noise and vibration; acceleration and deceleration forces; additional handling and temperature fluctuations. The transport team must stabilise the infant fully prior to transport as when on the move they are limited by space and movement to effectively attend to clinical deterioration. Inborn infants have better neurodevelopmental outcome compared with the outborn and aetiology of this seems to be multifactorial with the impact of transport itself during critical illness, remaining unclear. To improve the neurological outcomes for transported infants, it seems imperative to integrate the advancing intensive care neuromonitoring tools into the transport milieu. This review examines current inter-hospital transport neuromonitoring and how new modalities might be applied to the neurocritical care delivered by specialist transport teams.

Development of a Clinical Interface for a Novel Newborn Resuscitation Device: Human Factors Approach to Understanding Cognitive User Requirements.

BACKGROUND: A novel medical device has been developed to address an unmet need of standardizing and facilitating heart rate recording during neonatal resuscitation. In a time-critical emergency resuscitation, where failure can mean death of an infant, it is vital that clinicians are provided with information in a timely, precise, and clear manner to capacitate appropriate decision making. This new technology provides a hands-free, wireless heart rate monitoring solution that easily fits the clinical pathway and procedure for neonatal resuscitation. OBJECTIVE: This study aimed to understand the requirements of the interface design for a new device by using a human factors approach. This approach combined a traditional user-centered design approach with an applied cognitive task analysis to understand the tasks involved, the cognitive requirements, and the potential for error during a neonatal resuscitation scenario. METHODS: Fourteen clinical staff were involved in producing the final design requirements. Two pediatric doctors supported the development of a visual representation of the activities associated with neonatal resuscitation. This design was used to develop a scenario-based workshop. Two workshops were carried out in parallel and involved three pediatric doctors, three neonatal nurses, two advance neonatal practitioners, and four midwives. Both groups came together at the end to reflect on the findings from the separate sessions. RESULTS: The outputs of this study have provided a comprehensive description of information requirements during neonatal resuscitation and enabled product developers to understand the preferred requirements of the user interface design for the device. The study raised three key areas for the designers to consider, which had not previously been highlighted: (1) interface layout and information priority, as heart rate should be central and occupy two-thirds of the screen; (2) size and portability, to enable positioning of the product local to the baby's head and allow visibility from all angles; and (3) auditory feedback, to support visual information on heart rate rhythm and reliability of the trace with an early alert for intervention while avoiding parental distress. CONCLUSIONS: This study demonstrates the application of human factors and the applied cognitive task analysis method, which identified previously unidentified user requirements. This methodology provides a useful approach to aid development of the clinical interface for medical devices.

Risk of Severe Intraventricular Hemorrhage in the First Week of Life in Preterm Infants Transported Before 72 Hours of Age.

OBJECTIVES: Evaluate the risk of severe intraventricular hemorrhage, in the first week of life, in preterm infants undergoing early interhospital transport. DESIGN: Retrospective cohort study. SETTING: Tertiary neonatal centers of the Trent Perinatal Network in the United Kingdom. PATIENTS: Preterm infants less than 32 weeks gestation, who were either born within and remained at the tertiary neonatal center (inborn), or were transferred (transported) between centers in the first 72 hours of life. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Multivariable logistic regression models adjusting for key confounders were used to calculate odds ratios for intraventricular hemorrhage with 95% CIs for comparison of inborn and transported infants. Cranial ultrasound findings on day 7 of life. Secondary analyses were performed for antenatal steroid course and gestational age subgroups. A total of 1,047 preterm infants were included in the main analysis. Transported infants (n = 391) had a significantly higher risk of severe (grade III/IV) intraventricular hemorrhage compared with inborns (n = 656) (9.7% vs 5.8%; adjusted odds ratio, 1.69; 95% CI, 1.04-2.76), especially for infants born at less than 28 weeks gestation (adjusted odds ratio, 1.83; 95% CI, 1.03-3.21). Transported infants were less likely to receive a full antenatal steroid course (47.8% vs 64.3%; p < 0.001). A full antenatal steroid course significantly decreased the risk of severe intraventricular hemorrhage irrespective of transport status (odds ratio, 0.33; 95% CI, 0.2-0.55). However, transported infants less than 28 weeks gestation remained significantly more likely to develop a severe intraventricular hemorrhage despite a full antenatal steroid course (adjusted odds ratio, 2.84; 95% CI, 1.08-7.47). CONCLUSIONS: Preterm infants transported in the first 72 hours of life have an increased risk of early-life severe intraventricular hemorrhage even when maternal antenatal steroids are given. The additional burden of postnatal transport could be an important component in the pathway to severe intraventricular hemorrhage. As timely in-utero transfer is not always possible, we need to focus research on improving the transport pathway to reduce this additional risk.