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Background: There are 600 million girls in low and middle income countries (LMICs), many of whom are at great risk for poor health and education. There is thus great need for programs that can effectively improve wellbeing for these girls. Although many interventions have been developed to address these issues, most focus on health and education without integrating attention to social and emotional factors. This omission is unfortunate, as nascent evidence indicates that these factors are closely related to health and education. This paper describes the methods of a 4-arm randomized controlled trial among 3,560 adolescent girls in rural Bihar, India that tested whether adding an intervention targeting social-emotional issues (based on a "resilience framework") to an adolescent health intervention would improve emotional, social, physical, and educational wellbeing to a greater extent than its components and a control group. Study arms were: (1) Girls First, a combination of the Girls First Resilience Curriculum (RC) and the Girls First Health Curriculum (HC); (2) Girls First Resilience Curriculum (RC) alone; (3) Girls First Health Curriculum (HC) alone; and (4) a school-as-usual control group (SC).Methods: Seventy-six schools were randomized (19 per condition) and 74 local women with a tenth grade education were trained and monitored to facilitate the program. Quantitative data were collected from 3,560 girls over 4 assessment points with very low rates of participant attrition. Qualitative assessments were conducted with a subset of 99 girls and 27 facilitators.Results and Conclusions: In this article, we discuss guiding principles that facilitated trial implementation, including integrating diverse local and non-local sources of knowledge, focusing on flexibility of planning and implementation, prioritizing systematic measurement selection, and striking a balance between scientific rigor and real-world feasibility.Trial Registration: Clinicaltrials.gov NCT02429661 . Registered 24 April 2015. [ABSTRACT FROM AUTHOR]

Background: Secondary education and delayed marriage provide long-term socio-economic and health benefits to adolescent girls. We tested whether a structural and norms-based intervention, which worked with adolescent girls, their families, communities, and secondary schools to address poverty, schooling quality and gender norms, could reduce secondary school drop-out and child marriage among scheduled-caste/scheduled-tribe (SC/ST) adolescent girls in rural settings of southern India.Methods: 80 of 121 villages in Vijayapura and Bagalkote districts, Karnataka State, were randomly selected (control = 40; intervention = 40). All 12-13 year-old SC/ST girls in final year of primary school (standard 7th) were enrolled and followed for 3 years (2014-2017) until the end of secondary school (standard 10th). Primary trial outcomes were proportion of girls who completed secondary school and were married, by trial end-line (15-16 years). Analyses were intention-to-treat and used individual-level girl data.Results: 92.6% (2275/2457) girls at baseline and 72.8% (1788/2457) at end-line were interviewed. At end-line, one-fourth had not completed secondary school (control = 24.9%; intervention = 25.4%), and one in ten reported being married (control = 9.6%; intervention = 10.1%). These were lower than expected based on district-level data available before the trial, with no difference between these, or other schooling or sexual and reproductive outcomes, by trial arm. There was a small but significant increase in secondary school entry (adjusted odds ratio AOR = 3.58, 95% confidence interval CI = 1.36-9.44) and completion (AOR=1.54, 95%CI = 1.02-2.34) in Vijayapura district. The sensitivity and attrition analyses did not impact the overall result indicating that attrition of girls at end-line was random without much bearing on overall result.Conclusions: Samata intervention had no overall impact, however, it added value in one of the two implementation districts- increasing secondary school entry and completion. Lower than expected school drop-out and child marriage rates at end-line reflect strong secular changes, likely due to large-scale government initiatives to keep girls in school and delay marriage. Although government programmes may be sufficient to reach most girls in these settings, a substantial proportion of SC/ST girls remain at-risk of early marriage and school drop-out, and require targeted programming. Addressing multiple forms of clustered disadvantage among hardest to reach will be key to ensuring India "leaves no-one behind" and achieves its gender, health and education Sustainable Development Goal aspirations.Trial Registration: ClinicalTrials.gov registration number NCT01996241. [ABSTRACT FROM AUTHOR]

Peripherally inserted central catheter (PICC) and umbilical venous catheter (UVC) in terms of success rate, complications, cost and time of insertion in neonatal intensive care were compared. Neonates requiring vascular access for minimum 7 days were included. Sample size of 72 per group was determined. Trial was registered at Clinical Trials Registry of India (CTRI/2015/02/005529). Success rates of the UVC and PICC were 68.1% and 65.3%, respectively (p = 0.724). Mean (SD) time needed for PICC and UVC insertion was 34.13 (34.69) and 28.31 (17.19) min, respectively (p = 0.205). Mean (SD) cost of PICC insertion vs. UVC insertion was 60.9 (8.6) vs. 11.9 (8.7) US dollars (p < 0.0001). Commonest cause for failure of UVC was displacement [6 (8.3%)] and that for PICC was blockage [9 (12.5%)].Conclusions: UVC is a cheaper alternative to PICC, with similar success rate, short-term complications and time needed for insertion. [ABSTRACT FROM AUTHOR]

Objective: The aim of this article is to describe the incidence and characteristics of pregnancy-related death in low- and middle-resource settings, in relation to the availability of key obstetric resources.Design: This is a secondary analysis of a stepped-wedge cluster randomised controlled trial.Setting: This trial was undertaken at ten sites across eight low- and middle-income countries in sub-Saharan Africa, India and Haiti.Population: Institutional-level consent was obtained and all women presenting for maternity care were eligible for inclusion.Methods: Pregnancy-related deaths were collected prospectively from routine data sources and active case searching.Main Outcome Measures: Pregnancy-related death, place, timing and age of maternal death, and neonatal outcomes in women with this outcome.Results: Over 20 months, in 536 233 deliveries there were 998 maternal deaths (18.6/10 000, range 28/10 000-630/10 000). The leading causes of death were obstetric haemorrhage (36.0%, n = 359), hypertensive disorders of pregnancy (20.6%, n = 206), sepsis (14.1%, n = 141) and other (26.5%, n = 264). Approximately a quarter of deaths occurred prior to delivery (28.4%, n = 283), 35.7% (n = 356) occurred on the day of delivery and 35.9% (n = 359) occurred after delivery. Half of maternal deaths (50.6%; n = 505) occurred in women aged 20-29 years, 10.3% (n = 103) occurred in women aged under 20 years, 34.5% (n = 344) occurred in women aged 30-39 years and 4.6% (n = 46) occurred in women aged ≥40 years. There was no measured association between the availability of key obstetric resources and the rate of pregnancy-related death.Conclusions: The large variation in the rate of pregnancy-related death, irrespective of resource availability, emphasises that inequality and inequity in health care persists.Tweetable Abstract: Inequality and inequity in pregnancy-related death persists globally, irrespective of resource availability. [ABSTRACT FROM AUTHOR]

Objective: To determine whether Rojiroti microfinance, for poor Indian women, improves child nutrition.Design: Cluster randomised trial.Setting: Tolas (village communities) in Bihar State.Participants: Women and children under 5 years.Interventions: With Rojiroti microfinance, women form self-help groups and save their money to provide loans to group members. After 6 months, they receive larger external loans. Tolas were randomised to receive Rojiroti immediately or after 18 months.Outcome Measures: The primary analysis compared the mean weight for height Z score (WHZ) of children under 5 years in the intervention versus control tolas who attended for weight and height measurement 18 months after randomisation. Secondary outcomes were weight for age Z score (WAZ), height for age Z score, mid-upper arm circumference (MUAC), wasting, underweight and stunting.Results: We randomised 28 tolas to each arm and collected data from 2469 children (1560 mothers) at baseline and 2064 children (1326 mothers) at follow-up. WHZ was calculated for 1718 children at baseline and 1377 (674 intervention and 703 control) at follow-up. At 18 months, mean WHZ was significantly higher for intervention (-1.02) versus controls (-1.37; regression coefficient adjusted for clustering β=0.38, 95% CI 0.16 to 0.61, p=0.001). Significantly fewer children were wasted in the intervention group (122, 18%) versus control (200, 29%; OR=0.46, 95% CI 0.28 to 0.74, p=0.002). Mean WAZ was better in the intervention group (-2.13 vs -2.37; β=0.27, 95% CI 0.11 to 0.43, p=0.001) as was MUAC (13.6 cm vs 13.4 cm; β=0.22, 95% CI 0.03 to 0.40, p=0.02). In an analysis adjusting for baseline nutritional measures (259 intervention children and 300 control), only WAZ and % underweight showed significant differences in favour of the intervention.Conclusion: In marginalised communities in rural India, child nutrition was better in those who received Rojiroti microfinance, compared with controls.Trial Registration Number: NCT01845545. [ABSTRACT FROM AUTHOR]

Objective: To evaluate effect of one year exercise intervention program on bone mineral accrual in children and adolescent with cystic fibrosis (CF).Methods: Fifty-two CF children (mean age 149.79 mo) were randomized into experimental (15 boys and 10 girls) and control groups (15 boys and 12 girls). Experimental group performed prescribed exercises three times/week, while control group continued with routine physical activities for one year. Following were assessed at baseline and at one year: Bone mineral density (BMD) of whole body and lumbar spine, pulmonary function, exercise capacity, quality of life and habitual activity.Results: Change in whole body and lumbar spine BMD over 12 mo in experimental group was lower by 0.006 g/cm2 (95% CI -0.02 to 0.02) and higher by 0.001 g/cm2 (95% CI -0.04 to 0.03) than controls, respectively. However, difference between groups was non-significant for both parameters. Experimental group had a significant improvement in their exercise capacity (p = 0.006), quality of life, and serum vitamin D (p = 0.007) levels. Differences between groups for changes in pulmonary function and habitual activity were non-significant.Conclusions: Exercise regime was not associated with significant improvement in BMD of CF patients, but it had a positive impact on both physical and psychological health of these patients. [ABSTRACT FROM AUTHOR]

Objective: To determine whether oral clindamycin reduces the risk of preterm birth (PTB) in women with abnormal vaginal microflora as evidenced by a vaginal pH ≥5.0.Design: Randomised double-blind placebo-controlled trial.Setting: Rural southern India.Population: Pregnant women with a singleton fetus between 13+0/7 weeks and 20+6/7 weeks.Methods: Pregnant women were recruited during prenatal visits in Karnataka, India, from October 2013 to July 2015. Women were required to have a singleton fetus between 13+0/7 weeks and 20+6/7 weeks and an elevated vaginal pH (≥5.0) by colorimetric assessment. Participants were randomised to either oral clindamycin 300 mg twice daily for 5 days or an identical-appearing placebo.Main Outcome Measures: The primary outcome was the incidence of PTB, defined as delivery before 37+0/7 weeks.Results: Of the 6476 screened women, 1727 women were randomised (block randomised in groups of six; clindamycin n = 866, placebo n = 861). The demographic, reproductive, and anthropomorphometric characteristics of the study groups were similar. Compliance was high, with over 94% of capsules being taken. The rate of PTB before 37 weeks was comparable between the two groups [clindamycin 115/826 (13.9%) versus placebo 111/806 (13.8%), between-group difference 0.2% (95% CI -3.2 to 3.5%, P = 0.93)], as was PTB at less than 34 weeks [clindamycin 40/826 (4.8%) versus placebo group 37/806 (4.6%), between-group difference 0.3% (95% CI -1.8 to 2.3%, P = 0.81)]. No differences were detected in the incidence of birthweight of<2500 g, <1500 g, miscarriage, stillbirth or neonatal death.Conclusion: In this setting, oral clindamycin did not decrease PTB among women with vaginal pH ≥5.0.Tweetable Abstract: Oral clindamycin between 13+0/7 and 20+6/7 weeks does not prevent preterm birth in women with a vaginal pH ≥5.0. [ABSTRACT FROM AUTHOR]

Background: Low birth weight (LBW) infants constitute a vulnerable subset of infants with impaired immunity in early life. In India, there is scarcity of studies that focus on immunization practices in such infants. This analysis aimed to examine immunization practices in LBW infants with the intention to identify areas requiring intervention.Methods: Data on immunization status of LBW infants enrolled in an individually randomized, double-masked, placebo-controlled trial of neonatal vitamin A supplementation were analysed. Study outcomes were full immunization by one year of age and delayed vaccination with DPT1 and DPT3. Multivariable logistic regression was performed to identify factors associated with the outcome(s).Findings: Out of 10 644 LBW infants enrolled in trial, immunization data were available for 10 517 (98.8%). Less than one-third (29.7%) were fully immunized by one year of age. Lowest wealth quintile (adjusted odds ratio (AOR) 0.39, 95% confidence interval (CI) 0.32-0.47), Muslim religion (AOR 0.41, 95% CI 0.35-0.48) and age of mother <20 years (AOR 0.62, 95% CI 0.52-0.73) were associated with decreased odds of full immunization. Proportion of infants with delayed vaccination for DPT1 and DPT3 were 52% and 81% respectively. Lowest wealth quintiles (AOR 1.51, 95% CI 1.25-1.82), Muslim religion (AOR 1.41, 95% CI 1.21-1.65), mother aged <20 years (AOR 1.31, 95% CI 1.11-1.53) and birth weight <2000 g (AOR 1.20, 95% CI 1.03-1.40) were associated with higher odds of delayed vaccination for DPT-1. Maternal education (≥12 years of schooling) was associated with high odds of full immunization (AOR 2.39, 95% CI 1.97-2.91) and low odds of delayed vaccination for both DPT-1 (AOR 0.59, 95% CI 0.49-0.73) and DPT-3 (AOR 0.57, 95% CI 0.43-0.76).Conclusion: In this population, LBW infants are at a risk of delayed and incomplete immunization and therefore need attention. The risks are even higher in identified subgroups that should specifically be targeted. [ABSTRACT FROM AUTHOR]

Background: Heel prick is a frequent painful procedure in newborns. A lancet or a 26-gauge needle is used for a heel prick in India.Objective: To compare the pain caused by heel prick with a lancet or a 26-gauge needle in newborns admitted in the neonatal intensive care unit (NICU) using the preterm infant pain profile (PIPP).Methods: This randomized controlled trial was conducted over 2 months in a Level III NICU with a sample size of 40 subjects (20 in each group), which was required for the study to have a power of 80% with an alpha error of 0.05. Hemodynamically stable newborns on at least those on partial oral feeds undergoing heel prick for routine glucose monitoring were randomized into two groups within 48 h of NICU admission after informed parental consent: heel prick with a lancet or with a 26-gauge needle using computer-generated random numbers. Two milliliters of expressed breast milk was given 2 min before the heel prick. Pain before, during and after (1 and 5 min) was assessed using the PIPP score. The primary outcome measure was the PIPP score. The secondary outcome measures were the duration of audible cry and the number of pricks needed for an adequate sample. Statistical analysis was done using the Mann Whitney U test and Friedman's test on SPSS v.21. A p value of < 0.05 was significant.Results: There were 40 neonates, 24 males and 16 females included in the study with a median age of 7 days. The mean birth weight was 2441 g (SD: 699) at a mean gestation of 34.4 weeks (SD: 3.2). The median PIPP scores at 0-30 s after heel prick were 7.05 ± 3.57 with a lancet vs. 9.35 ± 3.68 a needle (p = 0.052). There was a significantly lower duration of audible cry with use of lancet (10.5 ± 18.5 s vs. 75.2 ± 12.0 s with needle; p = 0.03). All heel pricks resulted in adequate sampling.Conclusion: Heel prick with a lancet causes less crying than a 26-gauge needle, though the PIPP scores are not significantly different. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy and safety of 300,000 and 600,000 IU vitamin-D single-oral dose for the treatment of vitamin-D deficiency (VDD) in young children (3 mo - 3 y).Methods: This double-blind randomized control trial (Clinical Trail Registration-CTRI/2012/05/002621) was conducted in the Pediatric out-patient department (OPD) at a tertiary-care referral hospital. Children (3 mo - 3 y) with clinical/radiological features suggestive of VDD were screened; those found to be having 25(OH)D below 15 ng/ml and meeting inclusion and exclusion criteria's were enrolled after taking informed consent. They were randomized into two groups, one receiving 600,000 and other 300,000 IU vitamin-D orally stat (Stoss-therapy). Primary outcome measure was proportion of children developing hypercalcemia/and hypercalciuria at day 7-10 post-therapy. Secondary outcome measures were proportion of children with hypercalciuria at day 3-5, hypercalcemia/and hypercalciuria at day 25-30 and 25(OH)D sufficiency at day 25-30 post-therapy.Results: Sixty children, 30 in each group were randomized to two study groups. Baseline variables were comparable in two groups. Primary outcome measure (proportion of children with hypercalcemia/and hypercalciuria at 7 - 10th d) were 18.5 % (5/27) in 600,000 and 10.7 % (3/28) in 300,000 IU group (P = 0.47). Secondary outcome measures were - i) Proportion of children with hypercalciuria (3-5th d) were 18.5 % (5/27) in 600,000 and 7 % (2/28) in 300,000 group (P = 0.25). ii) Proportion of children with hypercalcemia/and hypercalciuria (25-30th d) were 18.5 % (5/27) in 600,000 and 11 % (3/28) in 300,000 group (P = 0.47). iii) All children in both groups had 25(OH)D levels in sufficiency range (25-30th d). With this sample size no significant difference in any of the group could be established.Conclusions: The superiority of 300,000 over 600,000 IU vitamin-D single-dose oral therapy for VDD in children (3 mo - 3 y) in terms of safety could not be established with this sample size, although the prevalence of hypercalcemia/and hypercalciuria was observed more with 600,000 IU group. Both the regimens were effective for treating VDD at 25-30th d post-therapy. [ABSTRACT FROM AUTHOR]

Background: Acute encephalitis syndrome (AES) is a public health problem in India. Neuroinfections are believed to be the most important etiology. Minocycline is a semisythetic tetracycline having excellent penetration into cerebrospinal fluid, established neuroprotective and antiviral properties besides action on nonviral causes of AES. It has been shown to be effective in animal model of Japanese encephalitis (JE). A randomized, controlled trial of nasogastric/oral minocycline in JE and AES at a single centre in Uttar Pradesh, northern India, was therefore conducted.Methods: Patients beyond 3 years of age - but excluding women aged 16-44 years - hospitalized with AES of < =7 days duration were enrolled and block randomized to receive nasogastric/oral minocycline or placebo suspension and followed up. Patients, study personnel and those entering data were blinded as to drug or placebo received. Primary outcome was cumulative mortality at 3 months from hospitalization. Analysis was by intention to treat.Results: 281 patients were enrolled, 140 received drug and 141 placebo. While there was no overall statistically significant difference in 3 month mortality between drug and placebo groups [RR = 0 · 83 (0 · 6-1 · 1)], there were encouraging trends in patients older than 12 years [RR = 0.70 (0.41-1.18)] and in Glasgow Outcome Score (GOS) at 3 months (χ(2) = 7 · 44, p = 0 · 059). These trends were further accentuated if patients dying within one day of reaching hospital were excluded [OR for 3 month mortality =0 · 70 (0 · 46-1 · 07), p = 0.090; 3 month GOS p = 0 · 028].Conclusions: A trend towards better outcomes was observed with minocycline, especially in those patients who survived the initial day in hospital. These findings should form the basis for planning a larger study and possibly including minocycline in the initial management of AES as seen here.Trial Registration: The trial was registered with Clinical Trials Registry of India (CTRI) - CTRI/2010/091/006143. [ABSTRACT FROM AUTHOR]

Objective: This study was conducted (i) to study through a randomized control trial the effect of Kangaroo Mother Care (KMC) on breast feeding rates, weight gain and length of hospitalization of very low birth neonates and (ii) to assess the acceptability of Kangaroo Mother Care by nurses and mothers.Methods: Babies whose birth weight was less than 1500 Grams were included in the study once they were stable. The effect of Kangaroo Mother Care on breast feeding rates, weight gain and length of hospitalization of very low birth weight neonates was studied through a randomized control trial in 28 neonates. The Kangaroo group (n = 14) was subjected to Kangaroo Mother Care of at least 4 hours per day in not more than 3 sittings. The babies received Kangaroo Care after shifting out from NICU and at home. The control group (n = 14) received only standard care (incubator or open care system). Attitude of mothers and nurses towards KMC was assessed on Day 3 +/- 1 and on day 7 +/- 1 after starting Kangaroo Care in a questionnaire using Likert's scale.Results: The results of the clinical trial reveal that the neonates in the KMC group demonstrated better weight gain after the first week of life (15.9 +/- 4.5 gm/day vs. 10.6 +/- 4.5 gm/day in the KMC group and control group respectively p < 0.05) and earlier hospital discharge (27.2 +/- 7 vs. 34.6 +/- 7 days in KMC and control group respectively, p < 0.05). The number of mothers exclusively breastfeeding their babies at 6 week follow-up was double in the KMC group than in the control group (12/14 vs. 6/14) (p < 0.05).Conclusion: KMC managed babies had better weight gain, earlier hospital discharge and, more impressively, higher exclusive breast-feeding rates. KMC is an excellent adjunct to the routine preterm care in a nursery. [ABSTRACT FROM AUTHOR]