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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. Interpretation Therapeutic hypothermia did not reduce the combined outcome of death or disability at 18 months after neonatal encephalopathy in low-income and middle-income countries, but significantly increased death alone. Therapeutic hypothermia should not be offered as treatment for neonatal encephalopathy in low-income and middle-income countries, even when tertiary neonatal intensive care facilities are available. Funding National Institute for Health Research, Garfield Weston Foundation, and Bill & Melinda Gates Foundation. Translations For the Hindi, Malayalam, Telugu, Kannada, Singhalese, Tamil, Marathi and Bangla translations of the abstract see Supplementary Materials section.

Introduction: The prevalence of diabetes mellitus (DM) is on the increase among general population and prenatal mothers. The feto-maternal outcome of mothers with DM varies with the type of DM, pre-pregnancy or gestational (PPDM and GDM), and glycemic control. Objective: The objective of this study is to assess the outcome of small- and large-for gestational-age (SGA and LGA) babies born to a cohort of mothers with PPDM and GDM and without DM. Materials and Methods: This cohort study was conducted in a tertiary care teaching hospital. A total of 480 mothers and their newborn babies were enrolled before 6 weeks of gestation and were categorized into PPDM, GDM, and no DM subgroups. Mothers were managed as per the standard protocols. Parameters observed were optimum/suboptimum glycemic control, neonatal weight, GA, morbidity, mortality, and neonatal intensive care unit (NICU) stay. Results: A total of 19.5% mothers had PPDM, including 70 mothers already diagnosed as DM, while 39% had GDM and 41.5% had no DM. The detection rate of PPDM was 5.6% and GDM was 17.5%. Majority of the mothers with PPDM and GDM required insulin and two-third had optimum glycemic control. Good glycemic control resulted in more appropriate-for-GA babies. SGA babies were more in PPDM group (54%), followed by GDM (26%) and non-DM (21%) subgroups, while LGA babies were less in these groups, i.e., 9.6%, 5.9%, and 0.5%, respectively. The following observations were statistically significant among PPDM compared to GDM: SGA (relative risk [RR] 2.1, 95% confidence interval [CI] 2.9–3.6), congenital anomalies (RR 3.3, 95% CI 5.1–8.8), and neonatal mortality (RR 4, 95% CI 2.1–3.2). Prematurity and NICU admission with longer stay were also more in PPDM. Macrosomia and birth injury were more in GDM. Hypoglycemia, longer NICU stay, and macrosomia were more with poor glycemic control. Conclusions: A change in profile with more SGA and less LGA babies was noted in this study. Differential short-term outcomes were noted, based on the onset of DM and glycemic control. Pre-pregnancy/early first-trimester screen followed by second and third trimester screens and optimum glycemic control, throughout pregnancy, is recommended.

Background: Disorders of sex development (DSD) are an important cause of management dilemma for a clinician, especially due to the difficulty in assigning a suitable sex to them. Not many studies are reported regarding their gender outcome. Objective: To find out the gender outcome of children with DSD. Materials and Methods: A hospital-based descriptive study was conducted in children with DSD from birth till 12 years of age who were attending pediatric outpatient department and ward and endocrinology clinic of a tertiary care teaching hospital of South India for 1 year. Children with DSD who were registered in endocrinology clinic over the preceding 10 years were called for review. Those came for review were also included. They were analyzed for their assigned gender at birth, etiological diagnosis, current gender role and phenotype, treatment and follow-up patterns. Reinvestigations were done in needed cases. Results: A total of 38 cases were analyzed in the study. Work up could be completed in 92.1% of children. 60.5% cases were diagnosed in infancy, and 18.42% (n=7) of cases were identified above 5 years. Among those who were not assigned any sex at birth, 50% became phenotypic male and 50% became phenotypic female. 25% of the patients, who were assigned male sex at birth, changed to female sex. 100% of 46 XX DSD are being reared as females but only 44.4% of 46 XY patient are being reared as males. Conclusion: Sex assignment in DSD, especially 46 XY DSD, is a great challenge. Sex assignment must be based on a definitive etiological diagnosis, its natural course, gender role, gender identity, external genital structure and reproductive outcome and with proper counseling of the parents. Strict follow-up is inevitable.

Background: Retinopathy of prematurity (ROP) is an important cause of visual and neurological impairment in premature infants. Identification of risk factors and effective management of the same will help in better outcomes. Information on ROP and its risk factors are limited especially from South India and interventions directed at prevention and treatments have produced only modest results. Methods: The study was of a prospective, unmatched case–control design and was conducted in premature, very low birth weight infants (

To investigate the causes of congenital hypothyroidism in children more than 3 years of age and to document the frequency of transient vs permanent hypothyroidism.Hospital based observational study.Pediatric endocrine clinic of a medical college.Children over 3 years of age, on treatment for congenital hypothyroidism.Thyroid function test (TFT) and thyroid ultrasound was done. Children with agenesis or hemiagenesis in thyroid ultrasound were identified. In children with normal or equivocal thyroid ultrasound, thyroxine was stopped and followed. Children with abnormal TFT on follow up had thyroid scintigraphy with or without potassium perchlorate discharge, after which, thyroid hormone supplement was restarted. Children who remained euthyroid on follow up were labeled as having transient hypothyroidism.Proportion of children with transient hypothyroidism.Among 36 children studied (20 boys and 16 girls), eighteen (50%) had transient hypothyroidism and fifteen (41.7%) had thyroid agenesis. There was one with hemiagenesis, one with ectopic thyroid and another with dyshormonogenesis (2.8% each). Initial TSH level at the time of diagnosis was higher in permanent hypothyroidism as compared with transient group (83.0 ± 31.6 vs 47.0 ± 33.1 mIU/mL; P= 0.002).Thyroid hormone supplementation could be discontinued in 50% of children diagnosed with congenital hypothyroidism.