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Background There is now convincing evidence that in industrialized countries therapeutic hypothermia for perinatal asphyxial encephalopathy increases survival with normal neurological function. However, the greatest burden of perinatal asphyxia falls in low and mid-resource settings where it is unclear whether therapeutic hypothermia is safe and effective. Aims Under the UCL Uganda Women's Health Initiative, a pilot randomized controlled trial in infants with perinatal asphyxia was set up in the special care baby unit in Mulago Hospital, a large public hospital with ~20,000 births in Kampala, Uganda to determine: The feasibility of achieving consent, neurological assessment, randomization and whole body cooling to a core temperature 33-34°C using water bottles The temperature profile of encephalopathic infants with standard care The pattern, severity and evolution of brain tissue injury as seen on cranial ultrasound and relation with outcome The feasibility of neurodevelopmental follow-up at 18-22 months of age Methods/Design Ethical approval was obtained from Makerere Unive r sity and Mulago Hospital. All infants were in-born. Parental consent for entry into the trial was obtained. Thirty-six infants were randomized either to standard care plus cooling (target rectal temperature of 33-34°C for 72 hrs, started within 3 h of birth) or standard care alone. All other aspects of management were the same. Cooling was performed using water bottles filled with tepid tap water (25°C). Rectal, axillary, ambient and surface water bottle temperatures were monitored continuously for the first 80 h. Encephalopathy scoring was performed on days 1-4, a structured, scorable neurological examination and head circumference were performed on days 7 and 17. Cranial ultrasound was performed on days 1, 3 and 7 and scored. Griffiths developmental quotient, head circumference, neurological examination and assessment of gross motor function were obtained at 18-22 months. Discussion We will highlight differences in neonatal care and infrastructure that need to be taken into account when considering a large safety and efficacy RCT of therapeutic hypothermia in low and mid resource settings in the future. Trial registration Current controlled trials ISRCTN92213707

The major causes of newborn deaths in sub-Saharan Africa are well-known and countries are gradually implementing evidence-based interventions and strategies to reduce these deaths. Facility-based care provides the best outcome for sick and or small babies; however, little is known about the cost and burden of hospital-based neonatal services on parents in West Africa, the sub-region with the highest global neonatal death burden. To estimate the actual costs borne by parents of newborns hospitalised with birth-associated brain injury (perinatal asphyxia) and preterm/low birth weight, this study examined economic costs using micro-costing bottom-up approach in two referral hospitals operating under the nationwide social health insurance scheme in an urban setting in Ghana. We prospectively assessed the process of care and parental economic costs for 25 out of 159 cases of perinatal asphyxia and 33 out of 337 cases of preterm/low birth weight admitted to hospital on the day of birth over a 3 month period. Results showed that medical-related costs accounted for 66.1% (IQR 49% - 81%) of out-of-pocket payments irrespective of health insurance status. On average, families spent 8.1% and 9.1% of their annual income on acute care for preterm/LBW and perinatal asphyxia respectively. The mean out-of-pocket expenditure for preterm/LBW was $147.6 (median $101.8) and for perinatal asphyxia was $132.3 (median $124). The study revealed important gaps in the financing and organization of health service delivery that may impact the quality of care for hospitalised newborns. It also provides information for reviewing complementary health financing options for newborn services and further economic evaluations.

To describe the patient population, priority diseases and outcomes in newborns admitted <48 hours old to neonatal units in both Kenya and Nigeria. In a network of seven secondary and tertiary level neonatal units in Nigeria and Kenya, we captured anonymised data on all admissions <48 hours of age over a 6-month period. 2280 newborns were admitted. Mean birthweight was 2.3 kg (SD 0.9); 57.0% (1214/2128) infants were low birthweight (LBW; <2.5kg) and 22.6% (480/2128) were very LBW (VLBW; <1.5 kg). Median gestation was 36 weeks (interquartile range 32, 39) and 21.6% (483/2236) infants were very preterm (gestation <32 weeks). The most common morbidities were jaundice (987/2262, 43.6%), suspected sepsis (955/2280, 41.9%), respiratory conditions (817/2280, 35.8%) and birth asphyxia (547/2280, 24.0%). 18.7% (423/2262) newborns died; mortality was very high amongst VLBW (222/472, 47%) and very preterm infants (197/483, 40.8%). Factors independently associated with mortality were gestation <28 weeks (adjusted odds ratio 11.58; 95% confidence interval 4.73-28.39), VLBW (6.92; 4.06-11.79), congenital anomaly (4.93; 2.42-10.05), abdominal condition (2.86; 1.40-5.83), birth asphyxia (2.44; 1.52-3.92), respiratory condition (1.46; 1.08-2.28) and maternal antibiotics within 24 hours before or after birth (1.91; 1.28-2.85). Mortality was reduced if mothers received a partial (0.51; 0.28-0.93) or full treatment course (0.44; 0.21-0.92) of dexamethasone before preterm delivery. Greater efforts are needed to address the very high burden of illnesses and mortality in hospitalized newborns in sub-Saharan Africa. Interventions need to address priority issues during pregnancy and delivery as well as in the newborn.

The ICD-10 categories of the diagnosis \"perinatal asphyxia\" are defined by clinical signs and a 1-minute Apgar score value. However, the modern conception is more complex and considers metabolic values related to the clinical state. A lack of consistency between the former clinical and the latter encoded diagnosis poses questions over the validity of the data. Our aim was to establish a refined classification which is able to distinctly separate cases according to clinical criteria and financial resource consumption. The hypothesis of the study is that outdated ICD-10 definitions result in differences between the encoded diagnosis asphyxia and the medical diagnosis referring to the clinical context. Routinely collected health data (encoding and financial data) of the University Hospital of Bern were used. The study population was chosen by selected ICD codes, the encoded and the clinical diagnosis were analyzed and each case was reevaluated. The new method categorizes the diagnoses of perinatal asphyxia into the following groups: mild, moderate and severe asphyxia, metabolic acidosis and normal clinical findings. The differences of total costs per case were determined by using one-way analysis of variance. The study population included 622 cases (P20 \"intrauterine hypoxia\" 399, P21 \"birth asphyxia\" 233). By applying the new method, the diagnosis asphyxia could be ruled out with a high probability in 47% of cases and the variance of case related costs (one-way ANOVA: F (5, 616) = 55.84, p < 0.001, multiple R-squared = 0.312, p < 0.001) could be best explained. The classification of the severity of asphyxia could clearly be linked to the complexity of cases. The refined coding method provides clearly defined diagnoses groups and has the strongest effect on the distribution of costs. It improves the diagnosis accuracy of perinatal asphyxia concerning clinical practice, research and reimbursement.

Abbreviations: AEA, average expert agreement; CAH, World Health Organization Child and Adolescent Health and Development Department; CHNRI, Child Health Nutrition Research Initiative; MDG, Millennium Development Goal; NE, neonatal encephalopathy; NIH, US National Institutes of Health; RPS, research priority score; World Health Organization, Summary Points * Intrapartum-related neonatal deaths (previously called \"birth asphyxia\") are the fifth most common cause of deaths among children under 5 years of age, accounting for an estimated 814,000 deaths each year, and also associated with significant morbidity, resulting in a burden of 42 million disability adjusted life years (DALYs). * This paper uses a systematic process developed by the Child Health Nutrition Research Initiative (CHNRI) to define and rank research options to reduce mortality from intrapartum-related neonatal deaths by the year 2015, in order to advance Millennium Development Goal (MDG) 4 for child survival. * A list of 61 research questions was developed and scored by 21 technical experts. The top one-third of the ranked research investment options was dominated by delivery (implementation) research, whilst discovery (basic science) questions were not ranked highly, especially for expected reduction of mortality and inequity in the short time to 2015. * Among the top four research questions, two relate to generation of demand for facility care at birth with specific mechanisms (such as transport and communication schemes, or financial incentives and conditional cash transfers).

Background Helping Babies Breathe (HBB) has become the gold standard globally for training birth-attendants in neonatal resuscitation in low-resource settings in efforts to reduce early newborn asphyxia and mortality. The purpose of this study was to do a first-ever activity-based cost-analysis of at-scale HBB program implementation and initial follow-up in a large region of Tanzania and evaluate costs of national scale-up as one component of a multi-method external evaluation of the implementation of HBB at scale in Tanzania. Methods We used activity-based costing to examine budget expense data during the two-month implementation and follow-up of HBB in one of the target regions. Activity-cost centers included administrative, initial training (including resuscitation equipment), and follow-up training expenses. Sensitivity analysis was utilized to project cost scenarios incurred to achieve countrywide expansion of the program across all mainland regions of Tanzania and to model costs of program maintenance over one and five years following initiation. Results Total costs for the Mbeya Region were $202,240, with the highest proportion due to initial training and equipment (45.2%), followed by central program administration (37.2%), and follow-up visits (17.6%). Within Mbeya, 49 training sessions were undertaken, involving the training of 1,341 health providers from 336 health facilities in eight districts. To similarly expand the HBB program across the 25 regions of mainland Tanzania, the total economic cost is projected to be around $4,000,000 (around $600 per facility). Following sensitivity analyses, the estimated total for all Tanzania initial rollout lies between $2,934,793 to $4,309,595. In order to maintain the program nationally under the current model, it is estimated it would cost $2,019,115 for a further one year and $5,640,794 for a further five years of ongoing program support. Conclusion HBB implementation is a relatively low-cost intervention with potential for high impact on perinatal mortality in resource-poor settings. It is shown here that nationwide expansion of this program across the range of health provision levels and regions of Tanzania would be feasible. This study provides policymakers and investors with the relevant cost-estimation for national rollout of this potentially neonatal life-saving intervention.

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.

ObjectiveTo assess the impact of hypothermic neural rescue for perinatal asphyxia at birth on healthcare costs of survivors aged 6–7 years, and to quantify the relationship between costs and overall disability levels.Design6–7 years follow-up of surviving children from the Total Body Hypothermia for Neonatal Encephalopathy (TOBY) trial.SettingCommunity study including a single parental questionnaire to collect information on children’s healthcare resource use.Patients130 UK children (63 in the control group, 67 in the hypothermia group) whose parents consented and returned the questionnaire.InterventionsIntensive care with cooling of the body to 33.5°C for 72 hours or intensive care alone.Main outcome measuresHealthcare resource usage and costs over the preceding 6 months.ResultsAt 6–7 years, mean (SE) healthcare costs per child were £1543 (£361) in the hypothermia group and £2549 (£812) in the control group, giving a saving of −£1005 (95% CI −£2734 to £724). Greater levels of overall disability were associated with progressively higher costs, and more parents in the hypothermia group were employed (64% vs 47%). Results were sensitive to outlying observations.ConclusionsCost results although not significant favoured moderate hypothermia and so complement the clinical results of the TOBY Children study. Estimates were however sensitive to the care requirements of two seriously ill children in the control group. A quantification of the relationship between costs and levels of disability experienced will be useful to healthcare professionals, policy makers and health economists contemplating the long-term economic consequences of perinatal asphyxia and hypothermic neural rescue.Trial registration numberThis study reports on the follow-up of the TOBY clinical trial: ClinicalTrials. gov number NCT01092637.

Background The need for cardiopulmonary resuscitation (CPR) is often unexpected, and the infrequent use of CPR in the delivery room (DR) limits the opportunity to perform rigorous clinical studies to determine the best method for delivering chest compression (CC) to newborn infants. The current neonatal resuscitation guidelines recommend using a coordinated 3:1 compression-to-ventilation (C:V) ratio (CC at a rate of 90/min and ventilations at a rate of 30/min). In comparison, providing CC during a sustained inflation (SI) (CC + SI) significantly improved hemodynamics, minute ventilation, and time to return of spontaneous circulation (ROSC) compared to 3:1 C:V ratio in asphyxiated piglets. Similarly, a small pilot trial in newborn infants showed similar results. Until now no study has examined different CC techniques during neonatal resuscitation in asphyxiated newborn infants in the DR. To date, no trial has been performed to directly compare CC + SI and 3:1 C:V ratio in the DR during CPR of asphyxiated newborn infants. Methods This is a large, international, multi-center, prospective, unblinded, cluster randomized controlled trial in asphyxiated newborn infants at birth. All term and preterm infants > 28 + 0 by best obstetrical estimate who require CPR at birth due to bradycardia (< 60/min) or asystole are eligible. The primary outcome of this study is to compare the time to ROSC in infants born > 28 + 0 weeks’ gestational age with bradycardia (< 60/min) or asystole immediately after birth who receive either CC + SI or 3:1 C:V ratio as the CPR strategy. Discussion Morbidity and mortality rates are extremely high for newborns requiring CC. We believe the combination of simultaneous CC and SI during CPR has the potential to significantly improve ROSC and survival. In addition, we believe that CC + SI might improve respiratory and hemodynamic parameters and potentially minimize morbidity and mortality in newborn infants. In addition, this will be the first randomized controlled trial to examine CC in the newborn period. Trial registration ClinicalTrials.gov, NCT02858583 . Registered on 8 August 2016