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Objective: Risk of malformations in children of women with epilepsy -- 5 years data from prospective, control study. Methods: All pregnant women, including women during preconception, who attended our hospital during years 2002-2007 were screened for women with history of epilepsy (WWE) and were enrolled for prospective study after obtaining due consent. Pregnant women, including women during preconception, who had neither history of epilepsy nor taking any anti epileptic drug (AED), but matched for age, parity and period of gestation were enrolled as control group. All women were given 5 mg of folic acid daily after enrolment, if not taking already, Women were followed up every trimester till delivery and children were followed up to early neonatal period. Details of malformations were noted in both groups. Results: 2.75, 598 pregnant women, attending our hospital, were screened during years 2002-2007 for history of epilepsy or intake of AED. There were 530 pregnant women with epilepsy (0.2%) and 8 other women were taking AED for reasons other than epilepsy. 8 WWE were excluded from study because of severe co morbid conditions or induced abortion for personal reasons other than fetal status. 522 WWE and 474 controls were recruited in the study. Outcome was known in 424 WWE and 387 controls. There were 395 live births (93.5%) in WWE and 378 (97.7%) in control group. Congenital malformations were seen in 13 children of WWE (3.0%) and in 7 children of control group (1.8%) and the difference was not statistically significant (P value 0.249). There is no significant difference in the type of malformations between the groups. AED intake as mono therapy or no AED intake during pregnancy in WWE showed no significant difference in the risk of malformations in children of WWE (Odds ratio 1.20 and 95% C.I. 0.91-1.57). But, intake of AED as poly therapy increased the risk of malformations (10.4% Odds ratio 4.87 95% C.I. 1.36-17.41). Use of carbamazapine was not associated with any malformation in the present study. Conclusions: More than 90% women with epilepsy delivered normal children. Risk of malformations did not show any significant increase over controls. AED monotherapy did not increase risk of malformations. Long duration of epilepsy and Polytherapy with multiple AED significantly increased risk of malformations in WWE. Use of Carbamazepine did not result in any malformation in the present study. [ABSTRACT FROM AUTHOR]

Objective: To assess the risk of abortions/stillbirths in women with epilepsy Methods: in a prospective, control study, pregnant women with epilepsy (WWE) and control group of pregnant women, who had neither history of epilepsy nor history of intake of antiepileptic drugs, but matched for age, parity and period of gestation were followed up till delivery to assess the risk of abortions/stillbirths. Women with severe comorbid conditions or women, who opted for medical termination of pregnancy for reasons unrelated to status of fetus were excluded from study. Results: 424 WWE and 387 controls were followed up till delivery. 29 WWE [6.8%] and 9 women in control group [2.3%] had abortion or stillbirth [P value 0.01]. Presence of generalized tonic clonic seizures during first trimester [14.7% vs 6.2% P value 0.05] and polytherapy with antiepileptic drugs [14.5% vs 5.4% P value 0.03] increased the risk of abortions/stillbirths in WWE. Use of antiepileptic drugs as monotherapy did not increase the risk of abortions or stillbirths in WWE. Conclusions: WWE had three times increased risk of abortions or stillbirths as compared to control group. Presence of generalized tonic clonic seizures during first trimester and use of polytherapy increased the risk in WWE, but antiepileptic drug use as monotherapy did not increase the risk of abortion or stillbirth in WWE. [ABSTRACT FROM AUTHOR]

Context: This study aimed to study feto-maternal outcomes in women with preterm prelabor rupture of membranes (PTPROM) on expectant management versus delivery at 34 weeks of gestation and correlate the period of latency and inflammatory markers with delivery outcomes. We have chosen this research topic as there is a paucity of specific guidelines regarding the optimal period of gestation for delivering women with PTPROM., Aim: The study correlated the feto-maternal outcomes in women with PTPROM on expectant management till 37 weeks versus delivery at 34 weeks with a period of latency and maternal inflammatory markers., Methods and Materials: This was a prospective observational study conducted on 262 women with PTPROM from 28-33+6 weeks of gestation. Women were monitored till 37 weeks with biweekly total leukocyte count and weekly C-reactive protein, urine routine microscopy, urine culture, high vaginal culture sensitivity, and ultrasound. Women were monitored expectantly till 37 weeks. However, intervention was done at any time during the feto-maternal compromise. There were 52 women who delivered <34 weeks and 210 women who delivered ≥34 weeks. Feto-maternal outcomes were documented. Group A was assigned to women who delivered before 34 weeks and Group B was assigned to women who delivered after 34 weeks. Statistical analysis was done using SPSS software. A p-value <0.05 was considered significant., Results: Among the study group, 238 (90.8%) women were managed expectantly while 24(9.1%) required intervention. A latency of 3-4 weeks was observed in 131(50%) women. Chorioamnionitis developed in 7 women (4.4%) in group A and 13 women (4.9%) in group B. Neonates developed sepsis in 5.7% in group A and 5.8 % in group B and were comparable in both the groups (p=1.000). Early neonatal death (END) occurred in 10 (3.8%) among which seven died because of low birth weight (LBW), two due to sepsis, and one due to respiratory distress. LBW was significantly associated with END (p<0.001) Conclusion: Expectant management beyond 34 weeks with close monitoring can improve neonatal outcomes without increasing maternal morbidity in women with PTPROM., Competing Interests: Human subjects: Consent was obtained or waived by all participants in this study. Vardhaman Mahavir Medical College and Safdarjung Hospital issued approval IEC/VMMC/SJH/THESIS/2020-11/CC-177. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Jha et al.)

The objective of this prospective observational study was to assess the growth and body composition of term small-for-gestational-age (SGA) infants from birth to 6 months and evaluate the effect of catch-up growth (CUG) on body composition. Term SGA newborns were recruited at birth. Anthropometry and body composition were evaluated at 3 days, 6, 10 and 14 weeks, and 6 months. Fat and fat-free mass (FM and FFM) were compared between infants with and without CUG (increase in weight Z -score by > 0·67) by air displacement plethysmography. Factors that could affect body composition and CUG, including parents' BMI and stature, infants' birth weight, sex and feeding, were evaluated. A total of 143 SGA newborns (sixty-six boys) with birth weight of 2336 (sd 214) g were enrolled; 109 were followed up till 6 months. Median weight Z -score increased from -2·3 at birth to -1·3 at 6 months, with 51·9 % of infants showing CUG. Infants with CUG had higher FM (1796 (sd 491) g v . 1196 (sd 474) g, P < 0·001) but similar FFM (4969 (sd 508) g v . 4870 (sd 622) g, P = 0·380), and consequently higher FM percentage (FM%) (26·5 (sd 5·8) v . 19·7 (sd 6·9), P < 0·001), compared with those without CUG. Lower birth weight, exclusive breast-feeding and higher parental stature were positively associated with CUG. In conclusion, CUG in term SGA infants in the first 6 months of life was almost entirely attributable to greater gain in FM. Follow-up of this cohort will provide insight into the long-term effect of disproportionate gain in FM in early infancy in SGA babies.

Background: Globally, recent estimates have shown there have been 3·6 million stillbirths and neonatal deaths in 2022, with nearly 60% occurring in low-income and middle-income countries. The Small Vulnerable Newborn Consortium has proposed a framework combining preterm birth (<37 weeks of gestation), small for gestational age (SGA) by INTERGROWTH-21st standard, and low birthweight (<2500 g) under the category small vulnerable newborns (SVN). Reliable data on SVN from sub-Saharan Africa, central Asia, and south Asia are sparse. We aimed to estimate the incidence of SVN and its types, and quantify risk factors, both overall and trimester-specific, from a pregnancy cohort in north India., Methods: In the GARBH-Ini (Interdisciplinary Group for Advanced Research on Birth Outcomes-DBT India Initiative) pregnancy cohort, 8000 participants were enrolled with less than 20 weeks' gestation between May 11, 2015, and Aug 8, 2020, at a secondary-care hospital in north India. The cohort was followed up across the antenatal period for a detailed study on preterm birth. We conducted a secondary analysis of cohort data for the outcome of SVN, classified into its types: preterm-SGA, preterm-nonSGA, and term-SGA. We estimated the relative risk and population attributable fraction of candidate risk factors for SVN (modified Poisson regression) and its types (multinomial regression)., Findings: 7183 (89·9%) of 7990 participants completed the study. Among 6206 newborns included for analysis, the incidence of SVN was 48·4% (35·1% term-SGA newborns [n=2179], 9·7% preterm-nonSGA newborns [n=605], and 3·6% preterm-SGA newborns [n=222]). Compared with term-nonSGA newborns, proportions of stillbirths and neonatal deaths within 72 h of birth among SVN were three times and 2·5 times higher, respectively. Preterm-SGA newborns had the highest incidence of stillbirth (15 [6·8%] of 222) and neonatal deaths (six [4·2%] of 142). Low body-mass index (BMI <18·5 kg/m 2 ) of participants at the start of pregnancy was associated with higher risk for preterm-SGA (adjusted relative risk [RR] 1·61 [95% CI 1·17-2·22]), preterm-nonSGA (1·35 [1·09-1·68]), and term-SGA (1·44 [1·27- 1·64]), with population attributable fraction ranging from 8·7% to 13·8%. Pre-eclampsia (adjusted RR 1·48 [95% CI 1·30-1·71]), short cervical length (1·15 [1·04-1·26]), and bacterial vaginosis (1·13 [0·88-1·45]) were other important antenatal risk factors., Interpretation: In a comprehensive analysis of SVN and its types from north India, we identified risk factors to guide prioritisation of interventions. Complemented with risk-stratification tools, this focused approach will enhance antenatal care, and accelerate achievement of Sustainable Development Goals-namely, to end preventable deaths of newborns and children younger than 5 years by 2030 (target 3·2)., Funding: Department of Biotechnology, Government of India and Grand Challenges India-Biotechnology Industry Research Assistance Council, Government of India., Translation: For the Hindi translation of the abstract see Supplementary Materials section., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Preterm and term small for gestational age (SGA) babies are at high risk of experiencing malnutrition and impaired neurodevelopment. Standalone interventions have modest and sometimes inconsistent effects on growth and neurodevelopment in these babies. For greater impact, intervention may be needed in multiple domains-health, nutrition, and psychosocial care and support. Therefore, the combined effects of an integrated intervention package for preterm and term SGA on growth and neurodevelopment are worth investigating., Methods: An individually randomized controlled trial is being conducted in urban and peri-urban low to middle-socioeconomic neighborhoods in South Delhi, India. Infants are randomized (1:1) into two strata of 1300 preterm and 1300 term SGA infants each to receive the intervention package or routine care. Infants will be followed until 12 months of age. Outcome data will be collected by an independent outcome ascertainment team at infant ages 1, 3, 6, 9, and 12 months and at 2, 6, and 12 months after delivery for mothers., Discussion: The findings of this study will indicate whether providing an intervention that addresses factors known to limit growth and neurodevelopment can offer substantial benefits to preterm or term SGA infants. The results from this study will increase our understanding of growth and development and guide the design of public health programs in low- and middle-income settings for vulnerable infants., Trial Registration: The trial has been registered prospectively in Clinical Trial Registry - India # CTRI/2021/11/037881, Registered on 08 November 2021., (© 2024. The Author(s).)

Importance: Multidomain interventions in pregnancy and early childhood have improved child neurodevelopment, but little is known about the effects of additional preconception interventions., Objective: To evaluate the effect of a multifaceted approach including health; nutrition; water, sanitation, and hygiene (WASH); and psychosocial support interventions delivered during the preconception period and/or during pregnancy and early childhood on child neurodevelopment., Design, Setting, and Participants: In this randomized trial involving low- and middle-income neighborhoods in Delhi, India, 13 500 participants were assigned to preconception interventions or routine care for the primary outcome of preterm births and childhood growth. Participants who became pregnant were randomized to pregnancy and early childhood interventions or routine care. Neurodevelopmental assessments, the trial's secondary outcome reported herein, were conducted in a subsample of children at age 24 months, including 509 with preconception, pregnancy, and early childhood interventions; 473 with preconception interventions alone; 380 with pregnancy and early childhood interventions alone; and 350 with routine care. This study was conducted from November 1, 2000, through February 25, 2022., Interventions: Health, nutrition, psychosocial care and support, and WASH interventions delivered during preconception, pregnancy, and early childhood periods., Main Outcomes and Measures: Cognitive, motor, language, and socioemotional performance at age 24 months, assessed using the Bayley Scales of Infant and Toddler Development 3 tool., Results: The mean age of participants at enrollment was 23.8 years (SD, 3.0 years). Compared with the controls at age 24 months, children in the preconception intervention groups had higher cognitive scores (mean difference [MD], 1.16; 98.3% CI, 0.18-2.13) but had similar language, motor, and socioemotional scores as controls. Those receiving pregnancy and early childhood interventions had higher cognitive (MD, 1.48; 98.3% CI, 0.49-2.46), language (MD, 2.29; 98.3% CI, 1.07-3.50), motor (MD, 1.53; 98.3% CI, 0.65-2.42), and socioemotional scores (MD, 4.15; 98.3% CI, 2.18-6.13) than did controls. The pregnancy and early childhood group also had lower incidence rate ratios (RRs) of moderate to severe delay in cognitive (incidence RR, 0.62; 98.3% CI, 0.40-0.96), language (incidence RR, 0.73; 98.3% CI, 0.57-0.93), and socioemotional (incidence RR, 0.49; 98.3% CI, 0.24-0.97) development than did those in the control group. Children in the preconception, pregnancy, and early childhood intervention group had higher cognitive (MD, 2.60; 98.3% CI, 1.08-4.12), language (MD, 3.46; 98.3% CI, 1.65-5.27), motor (MD, 2.31; 98.3% CI, 0.93-3.69), and socioemotional (MD, 5.55; 98.3% CI, 2.66-8.43) scores than did those in the control group., Conclusions and Relevance: Multidomain interventions during preconception, pregnancy and early childhood led to modest improvements in child neurodevelopment at 24 months. Such interventions for enhancing children's development warrant further evaluation., Trial Registration: Clinical Trials Registry-India CTRI/2017/06/008908.

Despite significant efforts and progress made in newborn care programs in India, implementation gaps persist across the continuum of care. The present case studies of two districts in Himachal Pradesh revealed that pathways of care were often fragmented with inconsistent linkages between facility and community due to poor documentation, lack of tiered referral, health system weaknesses, low utilization of primary level institutions, and inadequate post-natal home visits by Accredited Social Health Activists (ASHAs). Involvement of healthcare providers (HCPs) and frontline health workers (FHWs) was low and uneven in generating awareness across the districts with limited participation in supporting care in the community. Ensuring functionality of health centers and first-level care facilities; strengthening referral systems; adequate/trained human resources; strengthening routine health management systems, discharge processes and community-based care with adequate integration with facilities are necessary in closing access gaps., (© 2023. The Author(s), under exclusive licence to Dr. K C Chaudhuri Foundation.)

Objectives: To assess the diagnostic accuracy of Procalcitonin in maternal serum and umbilical cord blood samples to predict Early onset neonatal sepsis (EONS)., Study Design: It was a Prospective analytical cohort study. Pregnant women ≥ 34 weeks gestation in active labour, with risk factors for EONS were included in the study. Maternal blood samples at recruitment and umbilical cord blood samples after delivery were taken for Total leucocyte count (TLC), high sensitivity C-Reactive Protein (hs-CRP) and Procalcitonin. Newborns were classified into non-infected, suspected and proven infection. Sensitivity, specificity and diagnostic accuracy of maternal and cord blood procalcitonin, TLC and hs-CRP were calculated., Results: A total of 200 women were recruited. Maternal procalcitonin had a superior diagnostic accuracy of 99% compared to maternal TLC and maternal hs-CRP. Also, cord blood procalcitonin had a diagnostic accuracy of 95%., Conclusion: Procalcitonin in both maternal as well as cord blood is a promising biomarker to detect EONS with high diagnostic accuracy., Competing Interests: There are no conflicts of interest., (© 2023 The Authors.)

Background: Short and long term benefits of early Initiation of breastfeeding (EIBF) and exclusive breastfeeding (EBF) in the first six months of life are well established and recommended globally. However, reliable estimates of breastfeeding practices and impact of breastfeeding counselling interventions according to gestational age and weight at birth are not available in low and middle income countries., Objective: To assess the impact of breastfeeding counselling on EIBF and EBF during the first 6 months of life according to gestational age and weight at birth., Methods: We analysed the data collected from the Women and Infants Integrated Interventions for Growth Study (WINGS), an individually randomized factorial design trial. Mothers were counselled on EIBF during third trimester of pregnancy. They were supported throughout the first 6 months to continue EBF by early problem identification, frequent home visits and assistance in expressing breastmilk when direct breastfeeding was not possible. Breastfeeding practices were ascertained through 24 h recalls at infant ages 1, 3 and 5 months for both the intervention and control groups by an independent outcome ascertainment team. The World Health Organization (WHO) definitions were used for classification of infant breastfeeding practices. Generalized linear models of the Poisson family with a log-link function were used to estimate the effect of interventions on breastfeeding practices. The relative measures of effect on breastfeeding practices were estimated in term appropriate for gestational age (T-AGA), term small for gestational age (T-SGA), preterm AGA (PT-AGA), preterm SGA (PT-SGA) infants., Results: Amongst all infants irrespective of gestational age and weight at birth, EIBF was (51.7%) higher amongst the intervention group (IRR 1.38, 95% CI 1.28-1.48) compared with the control group. The proportion of exclusively breastfed infants at ages 1 month (IRR 1.37, 95% CI 1.28-1.48), 3 months (IRR 2.13, 95% CI 1.30-1.44) and 5 months (IRR 2.78, 95% CI 2.58-3.00) were higher in intervention group than control group. We identified significant interaction ( p value for interaction <0.05) between intervention and infant size and gestation at birth on exclusive breastfeeding at 3 and 5 months of age. Subgroup analysis showed that the impact of the intervention was greater on exclusive breastfeeding in PT- SGA infants at 3 months (IRR 3.30, 95% CI 2.20-4.96) and 5 months of age (IRR 5.26, 95% CI 2.98-9.28)., Conclusion: This is one of the first studies wherein impact of breastfeeding counselling interventions in the first 6 months of life was assessed according to infant size and gestation at birth wherein gestational age was reliably estimated. The impact of this intervention was higher in preterm and SGA babies compared to other infants. This finding is important as preterm and SGA infants have a higher burden of mortality and morbidity during early infancy. Intensive breastfeeding counselling to these vulnerable infants is likely to improve overall breastfeeding rates and reduce the adverse outcomes. Clinical Trial Registration : [http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339%26EncHid=%26userName=societyforappliedstudies], identifier [#CTRI/2017/06/008908]., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Sharma, Chowdhury, Taneja, Mazumder, Bhatia, Ghosh, Karantha, Dhabhai, Chellani, Bahl and Bhandari.)

Background: It is critical to identify high-risk groups among children with COVID-19 from low-income and middle-income countries (LMICs) to facilitate the optimum use of health system resources. The study aims to describe the severity and mortality of different clinical phenotypes of COVID-19 in a large cohort of children admitted to tertiary care hospitals in India., Methods: Children aged 0-19 years with evidence of SARS-CoV-2 infection (real time polymerase chain reaction or rapid antigen test positive) or exposure (anti-SARS-CoV-2 antibody, or history of contact with SARS-CoV-2) were enrolled in the study, between January 2021 and March 2022 across five tertiary hospitals in India. All study participants enrolled prospectively and retrospectively were followed up for three months after discharge. COVID-19 was classified into severe (Multisystem Inflammatory Syndrome in Children (MIS-C), severe acute COVID-19, 'unclassified') or non-severe disease. The mortality rates were estimated in different phenotypes., Findings: Among 2468 eligible children enrolled, 2148 were hospitalised. Signs of illness were present in 1688 (79%) children with 1090 (65%) having severe disease. High mortality was reported in MIS-C (18.6%), severe acute COVID-19 (13.3%) and the unclassified severe COVID-19 disease (12.3%). Mortality remained high (17.5%) when modified MIS-C criteria was used. Non-severe COVID-19 disease had 14.1% mortality when associated with comorbidity., Interpretation: Our findings have important public health implications for low resource settings. The high mortality underscores the need for better preparedness for timely diagnosis and management of COVID-19. Children with associated comorbidity or coinfections are a vulnerable group and need special attention. MIS-C requires context specific diagnostic criteria for low resource settings. It is important to evaluate the clinical, epidemiological and health system-related risk factors associated with severe COVID-19 and mortality in children from LMICs., Funding: Department of Biotechnology, Govt of India and Department of Maternal, Child and Adolescent Health and Aging, WHO, Geneva, Switzerland., Competing Interests: None., (© 2023 The Author(s).)

Background: To implement the immediate Kangaroo mother care (iKMC) intervention in the previous multicentre, open-label, randomised controlled trial, the mother or a surrogate caregiver and neonate needed to be together continuously, which led to the concept of the Mother-Newborn Care Unit (MNCU). Health-care providers and administrators were concerned of the potential increase in infections caused by the continuous presence of mothers or surrogates in the MNCU. We aimed to assess the incidence of neonatal sepsis in sub-groups and the bacterial profile among intervention and control neonates in the study population., Methods: This is a post-hoc analysis of the previous iKMC trial, which was conducted in five level 2 Newborn Intensive Care Units (NICUs) one each in Ghana, India, Malawi, Nigeria, and Tanzania, in neonates with birth weight 1 to <1.8 kg. The intervention was KMC initiated immediately after birth and continued until discharge and compared to conventional care with KMC initiated after meeting stability criteria. The primary outcomes of this report were the incidence of neonatal sepsis in sub-groups, sepsis-related mortality and bacterial profile of isolates during hospital stay. The original trial is registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12618001880235) and the Clinical Trials Registry-India (CTRI/2018/08/01536)., Findings: Between November 30, 2017, and January 20, 2020, 1609 newborns in the intervention group and in the control group 1602 newborns were enrolled in iKMC study. 1575 newborns in the intervention group and 1561 in the control group were clinically evaluated for sepsis. Suspected sepsis was 14% lower in intervention group in sub-group of neonates with birth weight 1.0-<1.5 kg; RR 0.86 (CI 0.75, 0.99). Among neonates with birth weight 1.5-<1.8 kg, suspected sepsis was reduced by 24%; RR 0.76 (CI 0.62, 0.93). Suspected sepsis rates were lower in intervention group than in the control group across all sites. Sepsis related mortality was 37% less in intervention group than the control group; RR 0.63 (CI 0.47-0.85) which was statistically significant. The intervention group had fewer cases of Gram-negative isolates (n = 9) than Gram positive isolates (n = 16). The control group had more cases of Gram-negative isolates (n = 18) than Gram positive (n = 12)., Interpretation: Immediate Kangaroo Mother care is an effective intervention to prevent neonatal sepsis and sepsis related mortality., Funding: The original trial was funded by the Bill and Melinda Gates Foundation through a grant to the World Health Organization (grant No. OPP1151718)., Competing Interests: All authors declare no competing interests., (© 2023 The Authors.)

Aim: To investigate the safety of skin-to-skin contact initiated immediately after birth on cardiorespiratory parameters in unstable low birth weight infants., Methods: A randomized clinical trial was conducted in tertiary newborn units in Ghana, India, Malawi, Nigeria and Tanzania in 2017-2020, in infants with birth weight 1.0-1.799 kg. The intervention was Kangaroo mother care initiated immediately after birth and continued until discharge compared to conventional care with Kangaroo mother care initiated after meeting stability criteria. The results of the primary study showed that immediate Kangaroo mother care reduced neonatal mortality by 25% and the results have been published previously. The post-hoc outcomes of this study were mean heart rate, respiratory rate, oxygen saturation during the first four days and the need of respiratory support., Results: 1,602 infants were allocated to control and 1,609 to intervention. Mean birth weight was 1.5 kg (SD 0.2) and mean gestational age was 32.6 weeks (SD 2.9) . Infants in the control group had a mean heart rate 1.4 beats per minute higher (95% CI -0.3-3.1, p  = 0.097), a mean respiratory rate 0.4 breaths per minute higher (-0.7-1.5, p  = 0.48) and a mean oxygen saturation 0.3% higher (95% CI -0.1-0.7, p  = 0.14) than infants in the intervention group., Conclusion: There were no significant differences in cardiorespiratory parameters during the first four postnatal days. Skin-to-skin contact starting immediately after birth is safe in low birth weight infants in limited-resource settings., Competing Interests: The authors report no conflicts of interest to declare., (.)

Introduction: It is unclear if serum procalcitonin (PCT) estimated at sepsis suspicion can help detect culture-positive sepsis in neonates. We evaluated the diagnostic performance of PCT in culture-positive sepsis in neonates., Methods: This was a prospective study (February 2016 to September 2020) conducted in four level-3 units in India. We enrolled neonates suspected of sepsis in the first 28 days of life. Neonates with birth weight &lt;750 g, asphyxia, shock, and major malformations were excluded. Blood for PCT assay was drawn along with the blood culture at the time of suspicion of sepsis and before antibiotic initiation. The investigators labeled the neonates as having culture-positive sepsis or "no sepsis" based on the culture reports and clinical course. PCT assay was performed by electrochemiluminescence immunoassay, and the clinicians were masked to the PCT levels while assigning the label of sepsis. Primary outcomes were the sensitivity, specificity, and likelihood ratios to identify culture-positive sepsis., Results: The mean birth weight (SD) and median gestation (IQR) were 2,113 (727) g and 36 (32-38) weeks, respectively. Of the 1,204 neonates with eligible cultures, 155 (12.9%) had culture-positive sepsis. Most (79.4%) were culture-positive within 72 h of birth. The sensitivity, specificity, and positive and negative likelihood ratios at 2 ng/mL PCT threshold were 52.3% (95% confidence interval: 44.1-60.3), 64.5% (60.7-68.1), 1.47 (1.23-1.76), and 0.74 (0.62-0.88), respectively. Adding PCT to assessing neonates with 12.9% pretest probability of sepsis generated posttest probabilities of 18% and 10% for positive and negative test results, respectively., Conclusion: Serum PCT did not reliably identify culture-positive sepsis in neonates., (© 2023 S. Karger AG, Basel.)

Objective: To determine the effect of integrated and concurrent delivery of health, nutrition, water, sanitation and hygiene (WaSH), and psychosocial care interventions during the preconception period alone, during pregnancy and early childhood, and throughout preconception, pregnancy, and early childhood on birth outcomes and linear growth at 24 months of age compared with routine care., Design: Individually randomised factorial trial., Setting: Low and middle income neighbourhoods of Delhi, India., Participants: 13 500 women were randomised to receive preconception interventions (n=6722) or routine care (n=6778). 2652 and 2269 pregnant women were randomised again to receive pregnancy and early childhood interventions or routine care. The analysis of birth outcomes included 1290 live births for the preconception, pregnancy, and early childhood interventions (group A), 1276 for the preconception intervention (group B), 1093 for the pregnancy and early childhood interventions (group C), and 1093 for the control (group D). Children aged 24 months by 30 June 2021 were included in the 24 month outcome analysis (453 in group A, 439 in B, 293 in C, and 271 in D)., Interventions: Health, nutrition, psychosocial care and support, and WaSH interventions were delivered during preconception, pregnancy, and early childhood periods., Main Outcome Measures: The primary outcomes were low birth weight, small for gestational age, preterm, and mean birth weight. At 24 months, the outcomes were mean length-for-age z scores and proportion stunted. Three prespecified comparisons were made: preconception intervention groups (A+B) versus no preconception intervention groups (C+D); pregnancy and early childhood intervention groups (A+C) versus routine care during pregnancy and early childhood (B+D) and preconception, pregnancy, and early childhood interventions groups (A) versus control group (D)., Results: The proportion with low birth weight was lower in the preconception intervention groups (506/2235) than in the no preconception intervention groups (502/1889; incidence rate ratio 0.85, 98.3% confidence interval 0.75 to 0.97; absolute risk reduction -3.80%, 98.3% confidence interval -6.99% to -0.60%). The proportion with low birth weight was lower in the pregnancy intervention groups (502/2096) than in the no pregnancy intervention groups (506/2028) but the upper limit of the confidence interval crossed null effect (0.87, 0.76 to 1.01; -1.71%, -4.96% to 1.54%). There was a larger effect on proportion with low birth weight in the group that received interventions in the preconception and pregnancy periods (267/1141) compared with the control group (267/934; 0.76, 0.62 to 0.91; -5.59%, -10.32% to -0.85%). The proportion stunted at 24 months of age was substantially lower in the pregnancy and early childhood intervention groups (79/746) compared with the groups that did not receive these interventions (136/710; 0.51, 0.38 to 0.70; -8.32%, -12.31% to -4.32%), and in the group that received preconception, pregnancy, and early childhood interventions (47/453) compared with the control group (51/271; 0.49, 0.32 to 0.75; -7.98%, -14.24% to -1.71%). No effect on stunting at 24 months was observed in the preconception intervention groups (132/892) compared with the no preconception intervention groups (83/564)., Conclusions: An intervention package delivered during preconception, pregnancy, and early childhood substantially reduced low birth weight and stunting at 24 months. Pregnancy and early childhood interventions alone had lower but important effects on birth outcomes and 24 month outcomes. Preconception interventions alone had an important effect on birth outcomes but not on 24 month outcomes., Trial Registration: Clinical Trial Registry-India CTRI/2017/06/008908., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the Biotechnology Industry Research Assistance Council of the Department of Biotechnology, Government of India and Bill and Melinda Gates Foundation, USA for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To determine the burden of early growth faltering and understand the care practices for small and sick babies discharged from newborn units in the district., Study Design: Observational and follow-up study., Participants: 512 babies discharged from two Special Newborn Care Units (SNCUs) and four Newborn Stabilization Units (NBSUs) in two districts of Himachal Pradesh., Methods: Anthropometric assessments, interview of mothers and Accredited Social Health Activists (ASHAs) conducted between August, 2018 and March, 2019. Change in weight-for-age z-score (DWAZ) of <-0.67SD between birth and assessment was used to define growth faltering., Outcomes: Proportion of growth faltering (or catch-down growth) in small and sick babies discharged from SNCUs and NBSUs, and infant care practices., Results: Growth faltering was observed in a significant proportion of both term (30%) and preterm (52.6%) babies between 1 to 4 months of age. Among babies with growth faltering (n=180), 73.9% received a home visit by ASHA, and only 36.7% received a follow-up visit at a facility. There were 71.3% mothers counselled at discharge (mostly informed about breast feeding). Most (96.7%) mothers did not perceive inadequate weight gain in their babies post-discharge. During home visits, ASHAs weighed 61.6% of the infants with growth faltering. Amongst infants who had growth faltering, only 49.6% of mothers had been provided information about their infant's growth and 57.1% mothers had received breastfeeding counselling., Conclusion: Small and sick newborn infants (both term and preterm babies) discharged from special care newborn units are at increased risk of early growth faltering. Follow-up care provided to these infants is inadequate. There is a need to strengthen both facility-based and home-based follow up of small and sick newborn infants discharged from newborn care facilities.

Background and Aims: Hypotension following subarachnoid block for cesarean delivery (CD) is common. We compared the effect of bolus administration of norepinephrine and phenylephrine on umbilical artery pH (primary objective) and their efficacy for the treatment of maternal hypotension (secondary objective) in term parturients undergoing elective CD under spinal anesthesia., Material and Methods: In a randomized, double-blinded study, parturients received 1 mL boluses of either phenylephrine 100 μg/mL (group phenylephrine; n = 45) or norepinephrine 7.5 μg/mL (group norepinephrine; n = 45) whenever maternal systolic blood pressure decreased to ≤80% of baseline. Maternal hemodynamic changes, vasopressor, and atropine requirement and neonatal outcome (umbilical cord blood gas analysis, Apgar scores, neonatal neurobehavioral response) were assessed., Results: The Apgar scores and umbilical cord blood gas analysis were comparable between groups. The neurobehavioral scale score was significantly higher in group NE compared with that in group PE at 24 h and 48 h; P = 0.007 and 0.002, respectively. The number of vasopressor doses and time to the first vasopressor requirement for maintaining systolic pressure >80% of baseline was comparable in both groups. Incidence of bradycardia ( P = 0.009), reactive hypertension ( P = 0.003), and dose requirement of atropine ( P = 0.005) was higher in group PE compared with group NE., Conclusions: In term normotensive parturients who received bolus norepinephrine 7.5 μg or phenylephrine 100 μg for the treatment of post-spinal hypotension during CD, neonatal umbilical cord blood gas analysis and Apgar scores were comparable. Norepinephrine use was associated with a lower incidence of maternal bradycardia and reactive hypertension compared with phenylephrine., Competing Interests: There are no conflicts of interest., (Copyright: © 2022 Journal of Anaesthesiology Clinical Pharmacology.)

Background: Lack of pediatric triage and emergency care system in peripheral healthcare centers leads to unnecessary referral of low- and medium-risk patients. This study was conducted to study the risk factors predicting mortality within 48 h of admission in neonates and under-five children referred to the pediatric emergency of a tertiary care hospital in India., Methods: This prospective study was conducted on children (0-5 years) referred to the pediatric emergency who were enrolled and followed up. The outcome was defined as "survival" or "death" at 48 hours. Logistic regression analysis was conducted to assess the predictors of early in-hospital mortality., Results: A total of 246 consecutive pediatric (62 neonates, 52 young infants, and 132 children aged 1-5 years) referral cases were enrolled; mortality within 48 hours was 20%. Lack of pediatric intensive care (odds ratio [OR] 4.07, 95% confidence interval [CI] 2.0, 8.32, P = 0.02), lack of neonatal intensive care (OR 2.10, 95% CI 1.01,4.28, P ≤ 0.001), distance from referral center >20 km (OR 4.61, 95% CI 2.01, 10.58, P = 0.0003), >1 h taken during transport (OR 7.75, 95% CI 2.93, 20.46, P < 0.001), lack of ambulance facility (OR 0.04, 95% CI 0.009, 0.143, P < 0.0001), very sick condition on arrival (OR 210.1, 95% CI 12.1, 3643.41, P = 0.0002), and unstable temperature-oxygenation-perfusion-sugar on arrival were the independent risk factors predicting in early in-hospital mortality., Conclusion: Developing a pediatric triage and monitoring system, tele-pediatric intensive care unit, regionalizing referral-back-referral services with robust interhospital communication, and strengthening pediatric emergency services are the need of the hour to reduce early in-hospital mortality., Competing Interests: None

While a Cochrane review (2016) showed that kangaroo mother care (KMC) initiated after clinical stabilization reduces mortality by 40%, evidence of the effect of initiating KMC immediately after birth without waiting for babies to become stable was unavailable until recently. This research gap was addressed by a multicountry, randomized, controlled trial co-ordinated by WHO. This trial was conducted in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania. Implementation of this trial led to development of the "mother-newborn care unit (MNCU)." Mother-newborn care unit or mother-newborn intensive care unit (M-NICU) is a facility where sick and small newborns are cared with their mothers 24 × 7 with all facilities of level II newborn care and provision for postnatal care to mothers. The mother is not a mere visitor, but she has her bed inside the special newborn care unit (SNCU)/newborn intensive care unit (NICU) and as a resident of MNCU, becomes an active caregiver and is involved in continuum of neonatal care. The study results show that intervention babies in MNCU had 25% less mortality at 28 d of life, 35% less incidence of hypothermia, and 18% less suspected sepsis as compared to control babies cared in conventional NICU. World Health Organization is in the process of reviewing the current recommendations on care of preterm or LBW newborns considering new evidence that has become available. However, it would require national policy change to permit mother and surrogate in SNCU/NICU 24 × 7, making the concept of zero-separation a reality., (© 2022. The Author(s).)

The paper attempts to capture the development of the Department of Pediatrics, Safdarjang Hospital, New Delhi, from a historical perspective in its founding years in late 1950s, showing the progress from its nascent state as a part of adult medicine to a full-fledged independent department with state-of-the-art advances in the 2020s. From an ordinary Pediatrics Department, it was reorganized radically to expand clinical facilities as well as education and research by innovative methods, developing subspecialties including an upgradation of the neonatology division, simultaneously establishing linkages with community level centres. The pioneering workshops for training obstetricians and pediatricians paved the way for initiation of multiple such national workshops across the country, by the Government of India, for establishment of neonatal care units countrywide. It was instrumental in the formulation of 'Essential New-born Care' as the first national newborn care program and later a new concept of 'Mother and Neonatal Care Unit (M-NICU)' for perinatal care, apart from many other contributions for shaping national policies.

Background: Information on exact causes of death and stillbirth are limited in low and middle income countries. Minimally invasive tissue sampling (MITS) is increasingly practiced in place of autopsy across several settings. A formative research documented the experiences of counselling and consenting for MITS in north India., Methods: This exploratory qualitative study was conducted at a tertiary care hospital in Delhi. During the early implementation of MITS, observations of the counselling and consenting process (n = 13) for under-five child death and stillbirths were conducted. In-depth interviews with MITS team members (n = 3) were also conducted. Observation and interview data were transcribed and inductively analysed using thematic content analysis to identify emerging themes and codes., Results: The MITS team participated in daily ward rounds for familiarisation with parents/families. Following death declaration the counselling was done in counselling corner of the ward or adjacent corridor. Mostly the counselling was targeted at the father and family members present, using verbal explanation and the consent document in local language. The key concerns raised by parents/family were possible disfigurement, time needed and possible benefits. Most of the parents consulted family members before consent. Among those who consented, desire for next pregnancy, previous pregnancy or neonatal loss and participation of treating senior doctor were the key factors. The negative experience of hospital care, poor comprehension and distance from residence were the factors for consent refusal. Lesser number of parents of deceased children consented for MITS compared to the neonates and stillbirths., Conclusions: The initial experiences of obtaining consent for MITS were encouraging. Consent for MITS may be improved with active involvement of the treating doctors and nurses, better bereavement support, private counselling area along with improvement in quality of care and communication during hospitalisation. Special efforts and refinement in counselling are needed to improve consent for MITS in older children., (© 2021. The Author(s).)

Background: Minimal invasive tissue sampling (MITS) has emerged as a suitable alternative to complete diagnostic autopsy (CDA) for determination of the cause of death (CoD), due to feasibility and acceptability issues. A formative research was conducted to document the perceptions of parents, community and religious leaders on acceptability of MITS., Methods: This qualitative study was conducted at and around the Safdarjung Hospital, Delhi, India. Participants for in-depth interview included the parents who had either child or neonatal death or stillbirth and the key community and religious representatives. The focus group discussions (FGDs) involved community members. Process of obtaining consent for MITS was observed. Data were analyzed inductively manually for emerging themes and codes., Results: A total of 104 interviews (parents of deceased children, neonates or stillbirths, n = 93; community members, n = 8 and religious leaders, n = 7), 8 FGDs (n = 72) were conducted and process of obtaining consent for MITS (n = 27) was observed. The participants were positive and expressed willingness to accept MITS. The key determinants for acceptance of MITS were: (1) understanding and willingness to know the cause of death or stillbirth, (2) experience of the healthcare received and trust, (3) the religious and sociocultural norms. Parents and community favored for MITS over CDA when needed, especially where in cases with past stillbirths and child deaths. The experience of treatment, attitude and communication from healthcare providers emerged as important for consent. The decision making process was collective involving the elders and family. No religious leader was against the procedure, as both, the respect for the deceased and need for medical care were satisfied., Conclusions: Largely, MITS appeared to be acceptable for identifying the causes of child deaths and stillbirths, if the parents and family are counseled appropriately considering the sociocultural and religious aspects. They perceived the quality of care, attitude and communication by the healthcare providers as critical factors for acceptance of MITS., (© 2021. The Author(s).)

Background: Neonatal sepsis is a major cause of death in India, which needs hospital management but many families cannot access hospitals. The World Health Organization and the Government of India developed a guideline to manage possible serious bacterial infection (PSBI) when a referral is not feasible. We implemented this guideline to achieve high coverage of treatment of PSBI with low mortality., Methodology: The implementation research study was conducted in over 50 villages of Palwal district, Haryana during August 2017-March 2019 and covered a population of 199143. Policy dialogue with central, state and district health authorities was held before initiation of the study. A baseline assessment of the barriers in the implementation of the PSBI intervention was conducted. The intervention was implemented in the program setting. The research team collected data throughout and also co-participated in the implementation of the intervention for the first six months to identify bottlenecks in the health system and at the community level. RE-AIM framework was utilized to document implementation strategies of PSBI management guideline. Implementation strategies by the district technical support unit (TSU) included: (i) empower mothers and families through social mobilization to improve care-seeking of sick young infants 0-59 days of age, (ii) build capacity through training and build confidence through technical support of health staff at primary health centers (PHC), community health centers (CHC) and sub-centers to manage young infants with PSBI signs and (iii) improve performance of accredited social health activists (ASHAs)., Findings: A total of 370 young infants with signs of PSBI were identified and managed in 5270 live births. Treatment coverage was 70% assuming that 10% of live births would have PSBI within the first two months of life. Mothers identified 87.6% (324/370) of PSBI cases. PHCs and CHCs became functional and managed 150 (40%) sick young infants with PSBI. Twenty four young infants (7-59days) who had only fast breathing were treated with oral amoxicillin without a referral. Referral to a hospital was refused by 126 (84%); 119 had clinical severe infection (CSI), one 0-6 days old had fast breathing and six had critical illness (CI). Of 119 CSI cases managed on outpatient injection gentamicin and oral amoxicillin, 116 (96.7%) recovered, 55 (45.8%) received all seven gentamicin injections and only one died. All 7-59 day old infants with fast breathing recovered, 23 on outpatient oral amoxicillin treatment; and 19 (79%) received all doses. Of 65 infants managed at either district or tertiary hospital, two (3.1%) died, rest recovered. Private providers managed 155 (41.9%) PSBI cases, all except one recovered, but sub-classification and treatment were unknown. Sub-centers could not be activated to manage PSBI., Conclusion: The study demonstrated resolution of implementation bottlenecks with existing resources, activated PHCs and CHCs to manage CSI and fast breathers (7-59 day old) on an outpatient basis with low mortality when a referral was not feasible. TSU was instrumental in these achievements. We established the effectiveness of oral amoxicillin alone in 7-59 days old fast breathers and recommend a review of the current national policy., Competing Interests: The authors have declared that no competing interest exist. Rajiv Bahl and Yasir Bin Nisar are staff members of the World Health Organization. The expressed views and opinions do not necessarily express the policies of the World Health Organization.

Background: "Kangaroo mother care," a type of newborn care involving skin-to-skin contact with the mother or other caregiver, reduces mortality in infants with low birth weight (<2.0 kg) when initiated after stabilization, but the majority of deaths occur before stabilization. The safety and efficacy of kangaroo mother care initiated soon after birth among infants with low birth weight are uncertain., Methods: We conducted a randomized, controlled trial in five hospitals in Ghana, India, Malawi, Nigeria, and Tanzania involving infants with a birth weight between 1.0 and 1.799 kg who were assigned to receive immediate kangaroo mother care (intervention) or conventional care in an incubator or a radiant warmer until their condition stabilized and kangaroo mother care thereafter (control). The primary outcomes were death in the neonatal period (the first 28 days of life) and in the first 72 hours of life., Results: A total of 3211 infants and their mothers were randomly assigned to the intervention group (1609 infants with their mothers) or the control group (1602 infants with their mothers). The median daily duration of skin-to-skin contact in the neonatal intensive care unit was 16.9 hours (interquartile range, 13.0 to 19.7) in the intervention group and 1.5 hours (interquartile range, 0.3 to 3.3) in the control group. Neonatal death occurred in the first 28 days in 191 infants in the intervention group (12.0%) and in 249 infants in the control group (15.7%) (relative risk of death, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P = 0.001); neonatal death in the first 72 hours of life occurred in 74 infants in the intervention group (4.6%) and in 92 infants in the control group (5.8%) (relative risk of death, 0.77; 95% CI, 0.58 to 1.04; P = 0.09). The trial was stopped early on the recommendation of the data and safety monitoring board owing to the finding of reduced mortality among infants receiving immediate kangaroo mother care., Conclusions: Among infants with a birth weight between 1.0 and 1.799 kg, those who received immediate kangaroo mother care had lower mortality at 28 days than those who received conventional care with kangaroo mother care initiated after stabilization; the between-group difference favoring immediate kangaroo mother care at 72 hours was not significant. (Funded by the Bill and Melinda Gates Foundation; Australian New Zealand Clinical Trials Registry number, ACTRN12618001880235; Clinical Trials Registry-India number, CTRI/2018/08/015369.)., (Copyright © 2021 Massachusetts Medical Society.)

Background: COVID-19 is disrupting health services for mothers and newborns, particularly in low- and middle-income countries (LMIC). Preterm newborns are particularly vulnerable. We undertook analyses of the benefits of kangaroo mother care (KMC) on survival among neonates weighing ≤2000 g compared with the risk of SARS-CoV-2 acquired from infected mothers/caregivers., Methods: We modelled two scenarios over 12 months. Scenario 1 compared the survival benefits of KMC with universal coverage (99%) and mortality risk due to COVID-19. Scenario 2 estimated incremental deaths from reduced coverage and complete disruption of KMC. Projections were based on the most recent data for 127 LMICs (~90% of global births), with results aggregated into five regions., Findings: Our worst-case scenario (100% transmission) could result in 1,950 neonatal deaths from COVID-19. Conversely, 125,680 neonatal lives could be saved with universal KMC coverage. Hence, the benefit of KMC is 65-fold higher than the mortality risk of COVID-19. If recent evidence of 10% transmission was applied, the ratio would be 630-fold. We estimated a 50% reduction in KMC coverage could result in 12,570 incremental deaths and full disruption could result in 25,140 incremental deaths, representing a 2·3-4·6% increase in neonatal mortality across the 127 countries., Interpretation: The survival benefit of KMC far outweighs the small risk of death due to COVID-19. Preterm newborns are at risk, especially in LMICs where the consequences of disruptions are substantial. Policymakers and healthcare professionals need to protect services and ensure clearer messaging to keep mothers and newborns together, even if the mother is SARS-CoV-2-positive., Funding: Eunice Kennedy Shriver National Institute of Child Health & Human Development; Bill & Melinda Gates Foundation; Elma Philanthropies; Wellcome Trust; and Joint Global Health Trials scheme of Department of Health and Social Care, Department for International Development, Medical Research Council, and Wellcome Trust., Competing Interests: We declare no competing interests., (© 2021 The Authors.)

Background: Grief following stillbirth and child death are one of the most traumatic experience for parents with psychosomatic, social and economic impacts. The grief profile, severity and its impacts in Indian context are not well documented. This study documented the grief and coping experiences of the Indian parents following stillbirth and child death., Methods: This exploratory qualitative study in Delhi (India) included in-depth interviews with parents (50 mothers and 49 fathers), who had stillbirth or child death, their family members (n = 41) and community representatives (n = 12). Eight focus group discussions were done with community members (n = 72). Inductive data analysis included thematic content analysis. Perinatal Grief Scale was used to document the mother's grief severity after 6-9 months of loss., Results: The four themes emerged were grief anticipation and expression, impact of the bereavement, coping mechanism, and sociocultural norms and practices. The parents suffered from disbelief, severe pain and helplessness. Mothers expressed severe grief openly and some fainted. Fathers also had severe grief, but didn't express openly. Some parents shared self-guilt and blamed the hospital/healthcare providers, themselves or family. Majority had no/positive change in couple relationship, but few faced marital disharmony. Majority experienced sleep, eating and psychological disturbances for several weeks. Mothers coped through engaging in household work, caring other child(ren) and spiritual activities. Fathers coped through avoiding discussion and work and professional engagement. Fathers resumed work after 5-20 days and mothers took 2-6 weeks to resume household chores. Unanticipated loss, limited family support and financial strain affected the severity and duration of grief. 57.5% of all mothers and 80% mothers with stillbirth had severe grief after 6-9 months., Conclusions: Stillbirth and child death have lasting psychosomatic, social and economic impacts on parents, which are usually ignored. Sociocultural and religion appropriate bereavement support for the parents are needed to reduce the impacts., Competing Interests: The authors have declared that no competing interests exist.

Objective: To determine the predictors of mortality following early rescue surfactant therapy in preterm babies with respiratory distress syndrome., Study Design: Prospective cohort study enrolling babies between 28 weeks to 34 weeks with respiratory distress syndrome requiring early rescue surfactant therapy. For statistical analysis babies were further divided into two subgroups: survivors and non-survivors. Maternal and neonatal variables were compared between the two groups to find out the predictors of mortality., Results: Out of total 110 babies, 72 (65.45%) survived. The mean birth weight and mean gestational age of the study population was 1614.36 (±487.86) g and 31.40 (±2.0)1 weeks, respectively. Birth weight < 1500 g, gestational age < 32 weeks, primiparity, vaginal delivery, prolonged rupture of membranes, lack of antenatal steroid cover, bag and mask ventilation at birth, sepsis, apneic episodes and mechanical ventilation were significantly associated with death on univariate analysis. On multivariate analysis, very low birth weight, vaginal delivery, lack of antenatal steroid cover, bag and mask ventilation at birth and mechanical ventilation were found to be independent predictors of mortality., Conclusions: Some of the identified predictors of mortality are modifiable and can be used to draw up a screening tool to predict the clinical severity and mortality among these babies.

Faltering of growth in early life has been recognized as a public health challenge among Indian babies. A two-day consultation on growth faltering in early infancy was organized to examine the data and evidence on identification and management of early growth failure and to identify knowledge gaps and future areas of research. The consultation was supported by the Biotechnology Industry Research Assistance Council (BIRAC), the Indian Academy of Pediatrics (Nutrition Chapter), Vardhman Mahavir Medical College and Safdarjung Hospital, and the Society for Applied Studies. It brought together researchers, clinicians, policy makers and program managers., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Background: India contributes the highest share of under-five and neonatal deaths and stillbirths globally. Diagnostic autopsy, although useful for cause of death identification, have limited acceptance. Minimally invasive tissue sampling (MITS) is an alternative to autopsy for identification of the cause of death (CoD). A formative research linked to pilot MITS implementation was conducted to document the perceptions and attitudes of the healthcare professionals and the barriers for implementation., Methods: This exploratory qualitative study conducted at a tertiary care hospital in New Delhi, India included the hospital staffs. In-depth interviews were conducted with the doctors, nurses and support staffs from pediatrics, neonatology, obstetrics and forensic medicine departments. Inductive data analysis was done to identify the emerging themes and codes., Results: A total of 26 interviews (doctors, n = 10; nurses, n = 9 and support staffs, n = 7) were conducted. Almost all professional and support staffs were positive about the MITS and its advantage for CoD identification including co-existing and underlying illnesses. Some opined conduct of MITS for the cases without clear diagnosis. All participants perceived that MITS would be acceptable for parents due to the non-disfigurement and preferred by those who had unexplained child deaths or stillbirths in past. The key factors for MITS acceptance were appropriate communication, trust building, involvement of senior doctors, and engagement of the counselor prior to deaths and training of the personnel. For implementation and sustenance of MITS, involvement of the institute authority and government stakeholders would be essential., Conclusions: MITS was acceptable for the doctors, nurses and support staffs and critical for better identification of the causes of death and stillbirths. The key facilitating factors and challenges for implementing MITS at the hospital in Indian context were identified. It emphasized on appropriate skill building, counseling, system organization and buy-in from institution and health authorities for sustenance of MITS.

Background: There is a growing interest in the life course approach for the prevention, early detection and subsequent management of morbidity in women of reproductive age to ensure optimal health and nutrition when they enter pregnancy. Reliable estimates of such morbidities are lacking. We report the prevalence of health or nutrition-related morbidities, specifically, anemia, undernutrition, overweight and obesity, sexually transmitted infections (STIs) or reproductive tract infections (RTIs), diabetes or prediabetes, hypothyroidism, hypertension, and depressive symptoms, during the preconception period among women aged 18 to 30 years., Methods: A cross-sectional study was conducted among 2000 nonpregnant married women aged 18 to 30 years with no or one child who wished to have more children in two low- to middle-income urban neighborhoods in Delhi, India, in the context of a randomized controlled trial. STIs and RTIs were measured by symptoms and signs, blood pressure by a digital device, height by stadiometer and weight by a digital weighing scale. A blood specimen was taken to screen for anemia, diabetes, thyroid disorders and syphilis. Maternal depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9). Multivariable logistic regression analysis was performed to identify sociodemographic factors associated with individual morbidity., Results: Overall, 58.7% of women were anemic; 16.5%, undernourished; 26%, overweight or obese; 13.2%, hypothyroid; and 10.5% with both symptoms and signs of STIs/RTIs. There was an increased risk of RTI/STI symptoms and signs in undernourished women and an increased risk of diabetes or prediabetes in overweight or obese women. An increased risk of undernutrition was also observed in women from lower categories of wealth quintiles. A decreased risk of moderate to severe anemia was seen in overweight women and those who completed at least secondary education., Conclusions: Our findings show a high burden of undernutrition, anemia, RTIs, hypothyroidism and prediabetes among women in the study. This information will aid policymakers in planning special programs for women of reproductive age., Competing Interests: The authors have declared that no competing interests exist.

Objectives: To determine the availability of continuous positive airway pressure (CPAP) and to provide an overview of its use in neonatal units in government hospitals across India., Setting: Cross-sectional cluster survey of a nationally representative sample of government hospitals from across India., Primary Outcomes: Availability of CPAP in neonatal units., Secondary Outcomes: Proportion of hospitals where infrastructure and processes to provide CPAP are available. Case fatality rates and complication rates of neonates treated with CPAP., Results: Among 661 of 694 government hospitals with neonatal units that provided information on availability of CPAP for neonatal care, 68.3% of medical college hospitals (MCH) and 36.6% of district hospitals (DH) used CPAP in neonates. Assessment of a representative sample of 142 hospitals (79 MCH and 63 DH) showed that air-oxygen blenders were available in 50.7% (95% CI 41.4% to 60.9%) and staff trained in the use of CPAP were present in 56.0% (45.8% to 65.8%) of hospitals. The nurse to patient ratio was 7.3 (6.4 to 8.5) in MCH and 6.6 (5.5 to 8.3) in DH. Clinical guidelines were available in 31.0% of hospitals (22.2% to 41.4%). Upper oxygen saturation limits of above 94% were used in 72% (59.8% to 81.6%) of MCH and 59.3% (44.6% to 72.5%) of DH. Respiratory circuits were reused in 53.8% (42.3% to 63.9%) of hospitals. Case fatality rate for neonates treated with CPAP was 21.4% (16.6% to 26.2%); complication rates were 0.7% (0.2% to 1.2%) for pneumothorax, 7.4% (0.9% to 13.9%) for retinopathy and 1.4% (0.7% to 2.1%) for bronchopulmonary dysplasia., Conclusions: CPAP is used in neonatal units across government hospitals in India. Neonates may be overexposed to oxygen as the means to detect and treat consequences of oxygen toxicity are insufficient. Neonates may also be exposed to nosocomial infections by reuse of disposables. Case fatality rates for neonates receiving CPAP are high. Complications might be under-reported. Support to infrastructure, training, guidelines implementation and staffing are needed to improve CPAP use., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The period from conception to two years of life denotes a critical window of opportunity for promoting optimal growth and development of children. Poor nutrition and health in women of reproductive age and during pregnancy can negatively impact birth outcomes and subsequent infant survival, health and growth. Studies to improve birth outcomes and to achieve optimal growth and development in young children have usually tested the effect of standalone interventions in pregnancy and/or the postnatal period. It is not clearly known whether evidence-based interventions in the different domains such as health, nutrition, water sanitation and hygiene (WASH) and psychosocial care, when delivered together have a synergistic effect. Further, the effect of delivery of an intervention package in the pre and peri-conception period is not fully understood. This study was conceived with an aim to understand the impact of an integrated intervention package, delivered across the pre and peri-conception period, through pregnancy and till 24 months of child age on birth outcomes, growth and development in children., Methods: An individually randomized controlled trial with factorial design is being conducted in urban and peri-urban low- to mid-socioeconomic neighbourhoods in South Delhi, India. 13,500 married women aged 18 to 30 years will be enrolled and randomized to receive either the pre and peri-conception intervention package or routine care (first randomization). Interventions will be delivered until women are confirmed to be pregnant or complete 18 months of follow up. Once pregnancy is confirmed, women are randomized again (second randomization) to receive either the intervention package for pregnancy and postnatal period or to routine care. Newborns will be followed up till 24 months of age. The interventions are delivered through different study teams. Outcome data are collected by an independent outcome ascertainment team., Discussion: This study will demonstrate the improvement that can be achieved when key factors known to limit child growth and development are addressed together, throughout the continuum from pre and peri-conception until early childhood. The findings will increase our scientific understanding and provide guidance to nutrition programs in low- and middle-income settings., Trial Registration: Clinical Trial Registry - India #CTRI/2017/06/008908; Registered 23 June 2017, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339&EncHid=&userName=society%20for%20applied%20studies.

Objective: To 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)., Design: A 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., Setting: 39 NNUs from 12 countries., Patients: Any neonate admitted to one of the participating NNUs., Interventions: This was an observational cohort study., Results: The 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%., Conclusion: AMR 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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)