Role of central endpoint adjudication and challenges in trials on neonatal sepsis-a case of ProSPoNS trial.

Despite progress in reducing the infant mortality in India, the neonatal mortality decline has been slower, necessitating concerted efforts to achieve Sustainable Development Goal-3. A promising strategy aiming to prevent neonatal sepsis in high-risk, vulnerable, low birth weight neonates through an innovative intervention includes probiotic supplementation. This article communicates the decision by the ProSPoNS trial investigators to establish a Central Endpoint Adjudication Committee (CEAC) as an addendum to the protocol published in Trials in 2021 for the purpose of clarifying the primary outcome.

Does the 3C (Counselling, Checking and Certification) Initiative Prevent Hypoglycemia Among At-Risk Stable Late Preterm and Term Neonates? - A Randomized Controlled Trial.

Objective: To evaluate whether the 3C (Counselling, Checking, Certification) initiative helps in preventing hypoglycemia among at-risk neonates compared to standard care.

Methods: This randomised controlled trial included 222 mother-newborn dyads with risk factors for neonatal hypoglycemia-Small for gestational age (SGA) babies, infants of diabetic mothers (IDM), large for gestational age (LGA) babies and late preterm infants (LPI). They were randomized to two groups.

Morbidity and Treatment-Seeking Pattern among Low Birth Weight Infants: A Community-based Cohort Study from Puducherry.

Background: To compare the morbidity and treatment-seeking pattern of low birth weight (LBW) and normal birth weight (NBW) infants during the first six months.

Material And Methods: A prospective cohort study was conducted in the service areas of eight urban primary health centers of Puducherry from October 2019 to July 2021. Details of LBW and sex-matched NBW infants were obtained from the birth registers of selected PHCs.

Effect of maternal hyperoxygenation on neonatal outcomes among women in labour with pathological cardiotocography: an open-label randomized controlled trial.

Background: Hyperoxygenation has shown promise in improving suspicious fetal heart patterns in women in labor. However, the effect of hyperoxygenation on neonatal outcomes in women in labor with pathologic fetal heart rate tracing has not been studied.

Objective: This study aimed to evaluate the effect of fractional inspiration of oxygen of 80% compared with fractional inspiration of oxygen of 40% on neonatal outcomes in women with pathologic fetal heart rate tracing.

A quality improvement project to improve voluntary milk donation in a human milk bank in South India.

Background: Mother's milk is the ideal food for a neonate. When mother's milk is unavailable for any reason, pasteurised donor human milk (PDHM) is the next best option. This quality improvement (QI) project aimed at improving voluntary donation in a public human milk bank (HMB) in South India.

Impact of Low Birth Weight on the Prevalence and Economic Burden of Common Childhood Illnesses Among Under-Five Children in India: Findings From Nationally Representative Surveys.

Background Common childhood illnesses such as diarrhea, fever, and acute respiratory infection impose substantial health burdens among under-five children, and Low Birth Weight (LBW) has been associated with an increased prevalence of these illnesses. However, the impact of LBW on healthcare utilization and the economic burden of these illnesses remains understudied. Aim To assess the impact of LBW on the prevalence, healthcare utilization, and Out of Pocket Expenditure (OOPE) for outpatient (OP) treatment of selected Common Childhood Illnesses (CCHI) among under-five children in India.

Patterns of antibiotic use, pathogens, and prediction of mortality in hospitalized neonates and young infants with sepsis: A global neonatal sepsis observational cohort study (NeoOBS).

Background: There is limited data on antibiotic treatment in hospitalized neonates in low- and middle-income countries (LMICs). We aimed to describe patterns of antibiotic use, pathogens, and clinical outcomes, and to develop a severity score predicting mortality in neonatal sepsis to inform future clinical trial design.

Methods And Findings: Hospitalized infants <60 days with clinical sepsis were enrolled during 2018 to 2020 by 19 sites in 11 countries (mainly Asia and Africa).

Congenital rubella syndrome surveillance in India, 2016-21: Analysis of five years surveillance data.

Background: In India, facility-based surveillance for congenital rubella syndrome (CRS) was initiated in 2016 to estimate the burden and monitor the progress made in rubella control. We analyzed the surveillance data for 2016-2021 from 14 sentinel sites to describe the epidemiology of CRS.

Method: We analyzed the surveillance data to describe the distribution of suspected and laboratory confirmed CRS patients by time, place and person characteristics.

Challenges in the Implementation of the NeoOBS Study, a Global Pragmatic Observational Cohort Study, to Investigate the Aetiology and Management of Neonatal Sepsis in the Hospital Setting.

Neonatal sepsis is a significant cause of mortality and morbidity in low- and middle-income countries. To deliver high-quality data studies and inform future trials, it is crucial to understand the challenges encountered when managing global multi-centre research studies and to identify solutions that can feasibly be implemented in these settings. This paper provides an overview of the complexities faced by diverse research teams in different countries and regions, together with actions implemented to achieve pragmatic study management of a large multi-centre observational study of neonatal sepsis.

Neonatal invasive candidiasis in low- and middle-income countries: Data from the NeoOBS study.

Neonatal invasive candidiasis (NIC) has significant morbidity and mortality. Reports have shown a different profile of those neonates affected with NIC and of fluconazole-resistant Candida spp. isolates in low- and middle-income countries (LMICs) compared to high-income countries (HICs).

Maternal and perinatal outcome of women with early-onset severe pre-eclampsia before 28 weeks: Is expectant management beneficial in a low-resource country? A prospective observational study.

Objective: To study the maternal and perinatal outcomes in women with severe pre-eclampsia before 28 weeks of pregnancy.

Methods: A descriptive study from a tertiary care center. All consecutive women with severe pre-eclampsia withonset before 28 weeks of pregnancy were included.

Incidence of Sepsis and Its Determinants among Neonates Admitted in Level III Neonatal Unit - A Prospective Observational Study.

Neonates are prone for sepsis due to their immature immune system. Sepsis is preventable if we aware of the maternal and neonatal risk factors. This study aimed to identify the incidence of sepsis and its risk factors.

Magnesium Sulfate as an Adjunct to Therapeutic Hypothermia in the Management of Term Infants with Hypoxic-Ischemic Encephalopathy: A Randomized, Parallel-Group, Controlled Trial.

Objective: To evaluate whether magnesium sulfate and therapeutic hypothermia in combination decreases mortality and/or major neurodevelopmental disability at 1 y of age among term neonates with hypoxic-ischemic encephalopathy.

Methods: A total of 134 term neonates were randomized to receive intravenous magnesium sulfate at a dose of 250 mg/kg (at 8 mg/kg/min) once daily for 3 d starting within 6 h after birth along with therapeutic hypothermia in the intervention group and therapeutic hypothermia alone in the comparator group. The primary outcome was the composite outcome of mortality and/or major neurodevelopmental disability (Developmental Assessment Scale for Indian Infants score < 70) at 1 y of age.

A Systematic Review of Antenatal Risk Scoring Systems in India to Predict Adverse Neonatal Outcomes.

Background: The purpose of antenatal care (ANC) is to identify 'at-risk' pregnant women, to provide quality care for all, and maximize the allocation of resources for those who need them the most. To address the synergistic effect of risk factors, clinicians across the globe developed antenatal scoring systems.

Objective: This review aims to investigate various antenatal risk scoring systems developed and used in India to predict adverse neonatal outcome.

Global DNA hypomethylation and the expression profile of DNA methyltransferase genes in late-onset neonatal sepsis.

Infectious organisms tend to cause DNA methylation changes. Thus, this paper aims to study global DNA methylation and the expression of DNA methyltransferase (DNMT) genes in late-onset neonatal sepsis (LONS). Global and Alu DNA methylation and expression levels of DNMT were performed using 5mc ELISA, methylation-specific PCR and quantitative real-time-PCR, respectively for LONS and controls.

Evaluation of T-piece resuscitator in the delivery room management of pre-term neonates with respiratory distress syndrome in resource-limited settings: A pre-post intervention study.

The aim of our study was to evaluate the impact of the T-piece resuscitator in the delivery room management of pre-term neonates in a resource-limited setting. We compared the incidence rates of delivery room intubation, surfactant replacement therapy, pulmonary air leak syndrome, and pre-term very low birth weight infant mortality, before and after T-piece use. Bi-monthly neonatal resuscitation training sessions were conducted for healthcare providers during the study period.

MicroRNA Expression in Neonates with Late-onset Sepsis - A Cross-sectional Comparative Study.

Background: Neonatal sepsis is a major health concern among neonates with higher morbidity and mortality rate. Studies have recently speculated the importance of differential expression of circulating mature micro-RNAs (miRNAs) which could serve as diagnostic as well as prognostic markers for risk of mortality in neonatal sepsis. This study aimed to analyze the expression pattern and to assess the diagnostic/prognostic value of miRNAs , and in late-onset neonatal sepsis.