Summary Background Although therapeutic hypothermia reduces death or disability after neonatal encephalopathy in high-income countries, its safety and efficacy in low-income and middle-income countries is unclear. We aimed to examine whether therapeutic hypothermia alongside optimal supportive intensive care reduces death or moderate or severe disability after neonatal encephalopathy in south Asia. Methods We did a multicountry open-label, randomised controlled trial in seven tertiary neonatal intensive care units in India, Sri Lanka, and Bangladesh. We enrolled infants born at or after 36 weeks of gestation with moderate or severe neonatal encephalopathy and a need for continued resuscitation at 5 min of age or an Apgar score of less than 6 at 5 min of age (for babies born in a hospital), or both, or an absence of crying by 5 min of age (for babies born at home). Using a web-based randomisation system, we allocated infants into a group receiving whole body hypothermia (33·5°C) for 72 h using a servo-controlled cooling device, or to usual care (control group), within 6 h of birth. All recruiting sites had facilities for invasive ventilation, cardiovascular support, and access to 3 Tesla MRI scanners and spectroscopy. Masking of the intervention was not possible, but those involved in the magnetic resonance biomarker analysis and neurodevelopmental outcome assessments were masked to the allocation. The primary outcome was a combined endpoint of death or moderate or severe disability at 18–22 months, assessed by the Bayley Scales of Infant and Toddler Development (third edition) and a detailed neurological examination. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov , NCT02387385 . Findings We screened 2296 infants between Aug 15, 2015, and Feb 15, 2019, of whom 576 infants were eligible for inclusion. After exclusions, we recruited 408 eligible infants and we assigned 202 to the hypothermia group and 206 to the control group. Primary outcome data were available for 195 (97%) of the 202 infants in the hypothermia group and 199 (97%) of the 206 control group infants. 98 (50%) infants in the hypothermia group and 94 (47%) infants in the control group died or had a moderate or severe disability (risk ratio 1·06; 95% CI 0·87–1·30; p=0·55). 84 infants (42%) in the hypothermia group and 63 (31%; p=0·022) infants in the control group died, of whom 72 (36%) and 49 (24%; p=0·0087) died during neonatal hospitalisation. Five serious adverse events were reported: three in the hypothermia group (one hospital readmission relating to pneumonia, one septic arthritis, and one suspected venous thrombosis), and two in the control group (one related to desaturations during MRI and other because of endotracheal tube displacement during transport for MRI). No adverse events were considered causally related to the study intervention. Interpretatio...

BackgroundTherapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as standard therapy in these settings. However, the safety and efficacy of cooling therapy in low- and middle-income countries (LMICs), where 99% of the disease burden occurs, remains unclear. We will examine whether whole body cooling reduces death or neurodisability at 18–22 months after neonatal encephalopathy, in LMICs.MethodsWe will randomly allocate 408 term or near-term babies (aged ≤ 6 h) with moderate or severe neonatal encephalopathy admitted to public sector neonatal units in LMIC countries (India, Bangladesh or Sri Lanka), to either usual care alone or whole-body cooling with usual care. Babies allocated to the cooling arm will have core body temperature maintained at 33.5 °C using a servo-controlled cooling device for 72 h, followed by re-warming at 0.5 °C per hour. All babies will have detailed infection screening at the time of recruitment and 3 Telsa cerebral magnetic resonance imaging and spectroscopy at 1–2 weeks after birth. Our primary endpoint is death or moderate or severe disability at the age of 18 months.DiscussionUpon completion, HELIX will be the largest cooling trial in neonatal encephalopathy and will provide a definitive answer regarding the safety and efficacy of cooling therapy for neonatal encephalopathy in LMICs. The trial will also provide important data about the influence of co-existent perinatal infection on the efficacy of hypothermic neuroprotection.Trial registrationClinicalTrials.gov, NCT02387385. Registered on 27 February 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2165-3) contains supplementary material, which is available to authorized users.

ObjectiveTo gain an understanding of the variation in available resources and clinical practices between neonatal units (NNUs) in the low-income and middle-income country (LMIC) setting to inform the design of an observational study on the burden of unit-level antimicrobial resistance (AMR).DesignA web-based survey using a REDCap database was circulated to NNUs participating in the Neonatal AMR research network. The survey included questions about NNU funding structure, size, admission rates, access to supportive therapies, empirical antimicrobial guidelines and period prevalence of neonatal blood culture isolates and their resistance patterns.Setting39 NNUs from 12 countries.PatientsAny neonate admitted to one of the participating NNUs.InterventionsThis was an observational cohort study.ResultsThe number of live births per unit ranged from 513 to 27 700 over the 12-month study period, with the number of neonatal cots ranging from 12 to 110. The proportion of preterm admissions <32 weeks ranged from 0% to 19%, and the majority of units (26/39, 66%) use Essential Medicines List ‘Access’ antimicrobials as their first-line treatment in neonatal sepsis. Cephalosporin resistance rates in Gram-negative isolates ranged from 26% to 84%, and carbapenem resistance rates ranged from 0% to 81%. Glycopeptide resistance rates among Gram-positive isolates ranged from 0% to 45%.ConclusionAMR is already a significant issue in NNUs worldwide. The apparent burden of AMR in a given NNU in the LMIC setting can be influenced by a range of factors which will vary substantially between NNUs. These variations must be considered when designing interventions to improve neonatal mortality globally.

A rapid and early diagnostic test to identify the encephalopathic babies at risk of adverse outcome may accelerate the development of neuroprotectants. We examined if a whole blood transcriptomic signature measured soon after birth, predicts adverse neurodevelopmental outcome eighteen months after neonatal encephalopathy. We performed next generation sequencing on whole blood ribonucleic acid obtained within six hours of birth from the first 47 encephalopathic babies recruited to the Hypothermia for Encephalopathy in Low and middle-income countries (HELIX) trial. Two infants with blood culture positive sepsis were excluded, and the data from remaining 45 were analysed. A total of 855 genes were significantly differentially expressed between the good and adverse outcome groups, of which RGS1 and SMC4 were the most significant. Biological pathway analysis adjusted for gender, trial randomisation allocation (cooling therapy versus usual care) and estimated blood leukocyte proportions revealed over-representation of genes from pathways related to melatonin and polo-like kinase in babies with adverse outcome. These preliminary data suggest that transcriptomic profiling may be a promising tool for rapid risk stratification in neonatal encephalopathy. It may provide insights into biological mechanisms and identify novel therapeutic targets for neuroprotection. Neonatal encephalopathy (NE) related to perinatal asphyxia is the most common cause of death and neurodisability in term babies with an incidence of 2 to 3 per 1,000 live births in high-income countries, and 10 to 20 per 1,000 livebirths in low and middle-income countries 1,2. In high income countries, therapeutic hypothermia partially improves outcomes, although adverse outcomes still occur in up to 30% of the cooled infants 3. As the underlying brain injury evolves over hours and days after birth, early identification of at-risk encephalopathic infants is challenging and often inaccurate, particularly in cooled infants 4. Furthermore, NE is heterogenous condition resulting from a multitude of aetiologies including acute or sub-acute perinatal hypoxia,

Background: Effective breastfeeding becomes an art with experience. Correct position and attachment is the first step necessary for exclusive breast feeding. However, studies assessing correct position and attachment for breastfeeding in South India are sparse. Hence our study aimed to assess the percentage of mother infant dyads with correct breastfeeding position and attachment along with factors influencing them in a Tertiary care Hospital.Methods: A descriptive cross-sectional study was conducted among the stable dyads in Institute of Obstetrics and Gynaecology using quasi random sampling. 101 dyads were observed for correct position, attachment and effective suckling using WHO B-R-E-A-S-T feed observation form and were scored. Data was analyzed using SPSS software with chi square test, univariate logistic regression and spearman correlation test.Results: Among the 101 dyads, only 30.7% of them had good or average position, 52.47% had good or average attachment and 62.3% had effective suckling at breast. There was significant correlation between breast problem in mother with incorrect position and poor attachment. NICU stay and breast problems were significantly associated with poor attachment. Effective suckling improved significantly as gestational age matured and in infants who had no NICU stay.Conclusions: Practical demonstration on how to hold infants in correct breastfeeding position and drilling with key points for correct position and attachment as soon as possible after delivery will go a long way for promoting exclusive and effective breastfeeding by learning correct technique. Rechecking after counselling will reinforce this learned art.

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Hyperammonaemia is a metabolic disease that can be known as ammonia levels in the bloodstream which can result in brain damage only if treated properly early at birth. Human disorders implicated in the nervous system's inborn metabolism defects are organic aciduria with secondary hyperammonaemia. Most organic aciduria during neonatal period or early infancy become clinically apparent. The metabolic disorders involved are metabolic stress state with extreme levels of hyperammonaemia above 1000 μmol / L which is the discriminative feature for metabolic disorders diagnosis. We presented this case which has been identified by unique test as propionic acidemia to demonstrate that severe high levels of ammonia can be seen in organic acidemias. A propionic acidemia is caused by a carboxylase deficiency of propionyl-CoA that accumulates toxic compounds that affect brain metabolism. This is classified as a haematological disorder under the hereditary metabolic disease. Propionic acidemia is an inherited metabolic condition in which the body was incapable of adequately processing such protein catabolism and oxidation defects. In most cases, within a few days after birth, the characteristics of this condition become obvious. The primary signs include poor eating, diarrhea, appetite loss, hypotonia, and lethargy. Mutations in the PCCA (alpha unit) and PCCB (beta unit)genes cause propionic acidemia; it has an autosomal recessive pattern of inheritance.