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Background : Preterm birth or low birth weight is the single largest cause of death in newborns, however this mortality can be reduced through newborn care interventions, including Kangaroo Mother Care (KMC). Previously, a multi-country randomized controlled trial, coordinated by the World Health Organization (WHO), reported a significant survival advantage with initiation of continuous KMC immediately after birth compared with initiation of continuous KMC a few days after birth when the baby is considered clinically stable. Whether the survival advantage would lead to higher rates of neurodevelopmental morbidities, or the immediate KMC will also have a beneficial effect on cognitive development also, has not been investigated. We therefore propose to test the hypothesis that low-birth-weight infants exposed to immediate KMC will have lower rates of neurodevelopmental impairment in comparison to traditional KMC-treated infants, by prospectively following up infants already enrolled in the immediate KMC trial for the first 2 years of life, and assessing their growth and neurodevelopment. Methods: This prospective cohort study will enroll surviving neonates from the main WHO immediate KMC trial. The main trial as well as this follow-up study are being conducted in five low- and middle-income countries in South Asia and sub-Saharan Africa. The estimated sample size for comparison of the risk of neurodevelopmental impairment is a total of 2200 children. The primary outcome will include rates of cerebral palsy, hearing impairment, vision impairment, mental and motor development, and epilepsy and will be assessed by the age of 3 years. The analysis will be by intention to treat. Discussion: Immediate KMC can potentially reduce low-birth-weight-associated complications such as respiratory disease, hypothermia, hypoglycemia, and infection that can result in impaired neurocognitive development. Neuroprotection may also be mediated by improved physiological stabilization that may lead to better maturation of neural pathways, reduced risk of hypoxia, positive parental impact, improved sleep cycles, and improved stress responses. The present study will help in evaluating the overall impact of KMC by investigating the long-term effect on neurodevelopmental impairment in the survivors. Trial registration: Clinical Trials Registry-India CTRI/2019/11/021899. Registered on 06 November 2019. Trials registration of parent trial: ACTRN12618001880235; Clinical Trials Registry-India: CTRI/2018/08/015369. [ABSTRACT FROM AUTHOR]

Background: Septicemia is an important cause of neonatal morbidity and mortality. However, organized data on causative organisms and their resistant pattern are scanty from developing countries. The changing trend in causative organisms and their antibiotic resistance is yet to be documented in India. The present study examines the trends in bacterial profile and antibiotic resistance of the organisms causing sepsis in hospitalized neonates. Materials and Methods: A retrospective laboratory‑based analysis of blood cultures obtained from Neonatal Intensive Care Unit of a tertiary care hospital in New Delhi was done for the period of 1999–2014, divided into five phases. Results: A total of 4700 isolates were considered. Over time, Gram‑negative organisms have replaced Gram‑positives as frequent isolates. Initially, there was predominance of Klebsiella pneumoniae, then of Staphylococcus aureus which recently has been changed with coagulase negative‑Staphylococcus and Acinetobacter. Growing resistance against the first and second line of drugs has been noted, including methicillin‑resistant S. aureus and vancomycin‑resistant Enterococcus. Conclusion: The etiological profile of neonatal sepsis has changed tremendously in the past 15 years. High resistance against common drugs necessitates continued surveillance and review of empirical antibiotic policy for neonatal sepsis. These steps are important to effectively curtail the surge of further antibiotic resistance. [ABSTRACT FROM AUTHOR]

BACKGROUND/OBJECTIVES:Vitamin D deficiency has been associated with impaired resistance to infection, which may be mediated by alterations in cytokine responses. We investigated the effect of vitamin D supplementation to infants on whole blood in-vitro cytokine production and on the inflammatory marker, plasma C-reactive protein (CRP).SUBJECTS/METHODS:Blood samples were taken at 6 months of age from infants participating in the DIVIDS (Delhi Infant Vitamin D Supplementation) randomized controlled trial of weekly vitamin D supplements (1400 IU=recommended intake) from birth to 6 months with the aim of decreasing mortality and severe morbidity. We measured plasma CRP and whole blood in-vitro production of tumour necrosis factor-α (TNFα), interferon-γ (INFγ), interleukin (IL)-10 and IL-13 following no stimulation or stimulation with lipopolysaccharide or phytohemagglutinin.RESULTS:Although the intervention improved vitamin D status in a severely deficient population, there were no differences between treatment groups in plasma CRP or in the production of any of the cytokines in either unstimulated or stimulated cultures. Recent illness had limited association with immunological markers. Plasma 25-hydroxyvitamin D levels were not associated with CRP or production of any cytokines.CONCLUSIONS:Vitamin D supplementation did not affect plasma CRP or whole blood cytokine production of vitamin D-deficient low birth weight infants. This is consistent with the lack of effect of vitamin D on mortality and severe morbidity among infants in the DIVIDS trial. [ABSTRACT FROM AUTHOR]

Aim: To determine the influence of gestation and weight on the development of protective anti-HB levels and geometric mean titres after three doses of HBV vaccine and to ascertain the need for a fourth dose in low birthweight infants.Methods: Hepatitis B vaccine (Enivac HB, Panacea Biotec Ltd., India) was given to 82 preterm (PT) and 60 term intrauterine growth-retarded (T-IUGR) infants at birth and at 6, 10 and 14wk of life.Results: Protective anti-HB levels (>10 mIU/ml) were reached in 86.6% (71/82) of PT infants and 96.7% (58/60) of T-IUGR infants after three doses of HBV vaccine (p = 0.044). The odds of having a protective response after the third dose of HBV vaccine was 1.25 (95% CI 1.02-1.53) with every one-week increase in gestation (p = 0.032). Birthweight was not associated with the development of a protective immune response. After the third dose, only 66.7% (8/12) of the PT infants whose mothers had anti-HB antibodies, developed protective anti-HB levels compared with 90% (63/70) of those with no maternal antibodies (p = 0.028). In PT infants after the fourth dose, there was a significant increase in the proportion of infants with protective antibody levels (8.6%, 95% CI 0.6-16.6%) among those with no maternal antibodies and 12.2% overall (95% CI 6.0-21.3) (p = 0.031 to 0.002) over that reached with the third dose. Administration of the fourth dose to T-IUGR infants did not confer such a benefit.Conclusion: In HBV-endemic areas, PT infants, irrespective of their birthweights, may benefit from an additional dose of hepatitis B vaccine in a schedule starting at birth. This approach will prevent vertical transmission and bring their immune response up to par with term infants. Term intrauterine growth-retarded infants should be vaccinated as per the schedule recommended for normal term infants. However, studies in other settings with different vaccine formulations and a longer follow-up period will be required before this strategy can be practised more widely. [ABSTRACT FROM AUTHOR]

Abdominal sonography of four infants with pyrexia and hepatomegaly demonstrated multiple hypoechoeic hepatic and splenic foci, guided biopsies of which showed caseating granulomas with acid-fast bacilli. Evidence of tuberculosis in maternal endometrium and its exclusion in the contacts further confirmed a diagnosis of congenital tuberculosis. Clinical suspicion supplemented by careful sonography facilitated early detection and antemortem diagnosis of this potentially fatal disease. [ABSTRACT FROM AUTHOR]

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]