Systematic review and meta-analysis of global birth prevalence of clubfoot: a study protocol.

INTRODUCTION: Clubfoot is a common congenital birth defect, with an average prevalence of approximately 1 per 1000 live births, although this rate is reported to vary among different countries around the world. If it remains untreated, clubfoot causes permanent disability, limits educational and employment opportunities, and personal growth. The aim of this systematic review and meta-analysis is to estimate the global birth prevalence of congenital clubfoot. METHODS AND ANALYSIS: Electronic databases including MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, Global Health, Latin American & Caribben Health Science Literature (LILACS), Maternity and Infant Care, Web of Science, Scopus and Google Scholar will be searched for observational studies based on predefined criteria and only in English language from inception of database in 1946 to 10 November 2017. A standard data extraction form will be used to extract relevant information from included studies. The Joanna Briggs Institute appraisal checklist will be used to assess the overall quality of studies reporting prevalence. All included studies will be assessed for risk of bias using a tool developed specifically for prevalence studies. Forest plots will be created to understand the overall random effects of pooled estimates with 95% CIs. An I2 test will be done for heterogeneity of the results (P>0.05), and to identify the source of heterogeneity across studies, subgroup or meta-regression will be used to assess the contribution of each variable to the overall heterogeneity. A funnel plot will be used to identify reporting bias, and sensitivity analysis will be used to assess the impact of methodological quality, study design, sample size and the impact of missing data. ETHICS AND DISSEMINATION: This review will be conducted completely based on published data, so approval from an ethics committee or written consent will not be required. The results will be disseminated through a peer-reviewed publication and relevant conference presentations. PROSPERO REGISTRATION NUMBER: CRD42016041922.

Benefits and risks of Iron interventions in children (BRISC): protocol for a three-arm parallel-group randomised controlled field trial in Bangladesh.

INTRODUCTION: Anaemia is a major global health problem affecting about 43% of preschool children globally and 60% of 6-24-month-old children in rural Bangladesh, half of which is attributed to iron deficiency (ID). Although WHO recommends universal supplementation with iron or home fortification with iron-containing multiple micronutrient powders (MMPs) to children under 2 years, evidence for benefits of these interventions on childhood development (a key rationale for these interventions) and harms (especially infection) remains limited. This study aims to evaluate the impact of iron or MMPs supplementation compared with placebo on (a) children's development, (b) growth, (c) morbidity from infections and (d) haematological and iron indices. METHODS AND ANALYSIS: This study is a three-arm, blinded, double-dummy, parallel-group, placebo-controlled superiority trial using stratified individual block randomisation. The trial will randomise 3300 children aged 8-9 months equally to arm 1: iron syrup (12.5 mg elemental iron), placebo MMPs; arm 2: MMPs (including 12.5 mg elemental iron), placebo syrup; and arm 3: placebo syrup, placebo MNPs. Children will receive interventions for 3 months based on WHO recommendations and then be followed up for 9 months post intervention. The primary outcome is cognitive composite score measured by Bayley III. Secondary outcomes include motor and language composite score by Bayley III, behaviour rating using selected items from Wolke's rating scales and BSID-II behaviour ratings, temperament, growth, haemoglobin, anaemia and iron status, and infectious morbidity. Outcomes will be measured at baseline, at the end of 3-month intervention and after 9 months postintervention follow-up. ETHICS AND DISSEMINATION: The trial has been approved by the Ethical Review Committee of icddr,b (Dhaka, Bangladesh) and the Melbourne Health Human Research Ethics Committee (Melbourne, Australia). Results of the study will be disseminated through scientific publications, presentations at international meetings and policy briefs to key stakeholders. TRIAL REGISTRATION NUMBER: ACTRN12617000660381;Pre-results. WHO UNIVERSAL TRIAL NUMBER: U1111-1196-1125.

Setting research priorities to improve global newborn health and prevent stillbirths by 2025.

BACKGROUND: In 2013, an estimated 2.8 million newborns died and 2.7 million were stillborn. A much greater number suffer from long term impairment associated with preterm birth, intrauterine growth restriction, congenital anomalies, and perinatal or infectious causes. With the approaching deadline for the achievement of the Millennium Development Goals (MDGs) in 2015, there was a need to set the new research priorities on newborns and stillbirth with a focus not only on survival but also on health, growth and development. We therefore carried out a systematic exercise to set newborn health research priorities for 2013-2025. METHODS: We used adapted Child Health and Nutrition Research Initiative (CHNRI) methods for this prioritization exercise. We identified and approached the 200 most productive researchers and 400 program experts, and 132 of them submitted research questions online. These were collated into a set of 205 research questions, sent for scoring to the 600 identified experts, and were assessed and scored by 91 experts. RESULTS: Nine out of top ten identified priorities were in the domain of research on improving delivery of known interventions, with simplified neonatal resuscitation program and clinical algorithms and improved skills of community health workers leading the list. The top 10 priorities in the domain of development were led by ideas on improved Kangaroo Mother Care at community level, how to improve the accuracy of diagnosis by community health workers, and perinatal audits. The 10 leading priorities for discovery research focused on stable surfactant with novel modes of administration for preterm babies, ability to diagnose fetal distress and novel tocolytic agents to delay or stop preterm labour. CONCLUSION: These findings will assist both donors and researchers in supporting and conducting research to close the knowledge gaps for reducing neonatal mortality, morbidity and long term impairment. WHO, SNL and other partners will work to generate interest among key national stakeholders, governments, NGOs, and research institutes in these priorities, while encouraging research funders to support them. We will track research funding, relevant requests for proposals and trial registers to monitor if the priorities identified by this exercise are being addressed.