Publications

2017
Chandyo, RK, et al. 2017. “The effects of vitamin B12 supplementation in pregnancy and postpartum on growth and neurodevelopment in early childhood: Study Protocol for a Randomized Placebo Controlled Trial”. BMJ Open 7. Publisher's VersionAbstract
Introduction Vitamin B12 is crucial for normal cell division
and differentiation, and necessary for the development
and myelination of the central nervous system. Pregnant
mothers in resource poor settings are at risk for poor
vitamin B12 status. Poor vitamin B12 status in infancy
is linked to poor growth and neurodevelopment. Brain
development starts from conception, and pregnancy is a
period of rapid growth and development for the brain.
Methods and analysis The study is an individually
randomised double-blind placebo controlled trial in 800
pregnant Nepalese women randomised in a 1:1 ratio. A daily
dose of 50 μg of vitamin B12 or placebo is given to women
from early pregnancy, not later than week 15, until 6 months
after birth. Weekly visits are conducted in order to record
compliance, growth and morbidity. The primary outcomes are
scores on the cognitive, language and motor subscales of the
Bayley Scales of Infant and Toddler Development, Third Edition,
measured at 6 and 12 months of age, and growth (length and
weight) measured at 6 and 12 months of age.
Ethics and dissemination National Health and Research
Council, Nepal (NHRC 253/2016) and Regional Committee
for Medical and Health Research Ethics of Western
Norway (2016/1620/REK vest) have approved the study.
Investigators who have contributed to the conceptualising,
conducting, as well as being involved in the data analyses
and manuscript writing will be eligible for authorship
and be responsible to share outcomes with different
stakeholders through publications and workshops.
The results from this study may support new dietary
guidelines for Nepalese and possibly South Asian pregnant
women that can lead to improved pregnancy outcomes,
neurodevelopment and cognitive functioning in children.
Trial registration number Universal Trial Number:
U1111-1183-4093. Trial registration: clinicaltrials. gov:
NCT03071666. Protocol date: version 1.2, 1 June 2017.
Mori, AT, et al. 2017. “Cost-benefit and extended cost-effectiveness analysis of a comprehensive adolescent pregnancy prevention program in Zambia: study protocol for a cluster randomized controlled trial”. Trials 18 (604). Publisher's VersionAbstract

Background: Early marriages, pregnancies and births are the major cause of school drop-out among adolescent

girls in sub-Saharan Africa. Birth complications are also one of the leading causes of death among adolescent girls.

This paper outlines a protocol for a cost-benefit analysis (CBA) and an extended cost-effectiveness analysis (ECEA) of

a comprehensive adolescent pregnancy prevention program in Zambia. It aims to estimate the expected costs,

monetary and non-monetary benefits associated with health-related and non-health outcomes, as well as their

distribution across populations with different standards of living.

Methods: The study will be conducted alongside a cluster-randomized controlled trial, which is testing the hypothesis

that economic support with or without community dialogue is an effective strategy for reducing adolescent childbearing

rates. The CBA will estimate net benefits by comparing total costs with monetary benefits of health-related and

non-health outcomes for each intervention package. The ECEA will estimate the costs of the intervention

packages per unit health and non-health gain stratified by the standards of living. Cost data include program

implementation costs, healthcare costs (i.e. costs associated with adolescent pregnancy and birth complications

such as low birth weight, pre-term birth, eclampsia, medical abortion procedures and post-abortion complications) and

costs of education and participation in community and youth club meetings. Monetary benefits are returns to education

and averted healthcare costs. For the ECEA, health gains include reduced rate of adolescent childbirths and non-health

gains include averted out-of-pocket expenditure and financial risk protection. The economic evaluations will

be conducted from program and societal perspectives.

Discussion: While the planned intervention is both comprehensive and expensive, it has the potential to produce

substantial short-term and long-term health and non-health benefits. These benefits should be considered seriously

when evaluating whether such a program can justify the required investments in a setting with scarce resources. The

economic evaluations outlined in this paper will generate valuable information that can be used to guide large-scale

implementation of programs to address the problem of the high prevalence of adolescent childbirth and school

drop-outs in similar settings.

Trial registration: ClinicalTrials.gov, NCT02709967. Registered on 2 March 2016. ISRCTN, ISRCTN12727868.

Registered on 4 March 2016.

Keywords: Adolescent pregnancy, Early marriage, School drop-out, Cost-benefit analysis, Extended cost-effectiveness

analysis, Cash transfer, Catastrophic health expenditure, Cluster randomized controlled trial.

Munhoz, TN, et al. 2017. “Effect of childhood nutrition counselling onintelligence in adolescence: a 15-year follow-up of a cluster-randomised trial”. Public Health Nutr 20 (11) : 2034-2041. Publisher's VersionAbstract

The present study aimed to assess the effects of an early childhood nutrition counselling intervention on intelligence (as measured by the intelligence quotient (IQ)) at age 15–16 years.

A single-blind, cluster-randomised trial.

In 1998, in Southern Brazil, mothers of children aged 18 months or younger were enrolled in a nutrition counselling intervention (n 424). Counselling included encouragement and promotion of exclusive breast-feeding until 6 months of age and continued breast-feeding supplemented by protein-, lipid- and carbohydrate-rich foods after age 6 months up to age 2 years. The control group received routine feeding advice. In 2013, the fourth round of follow-up of these individuals, at the age of 15–16 years, was undertaken. IQ was assessed using the short form of the Wechsler Adult Intelligence Scale (WAIS-III). Mental disorders (evaluated using the Development and Well-Being Assessment (DAWBA)) and self-reported school failure, smoking and alcohol use were also investigated. Adjusted analyses were conducted using a multilevel model in accordance with the sampling process.

Adolescents, mean (sd) age of 15·4 (0·5) years (n 339).

Mean (sd) total IQ score was lower in the intervention group than the control group (93·4 (11·4) and 95·8 (11·2), respectively) but the association did not persist after adjustment. The prevalence of any mental disorders was similar between intervention and control groups (23·1 and 23·5 %, respectively). There were no differences between groups regarding school failure, smoking and alcohol use.

Nutrition counselling intervention in early childhood had no effect on intelligence measured during adolescence.

Upadhyay, RP, et al. 2017. “Immunization practices in low birth weightinfants from rural Haryana, India: Findings fromsecondary data analysis”. Journal of Global Health 7 (2). Publisher's VersionAbstract

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.

Sinah, B, et al. 2017. “Integrated Interventions Delivered in Health Systems, Home, and Community Havethe Highest Impact on Breastfeeding Outcomes in Low- and Middle-Income Countries.”. J Nutr. 147 (11) : 2179S-2187S. Publisher's VersionAbstract

Background: Improving breastfeeding rates is critical. In low- and middle-income countries (LMICs), only subtle improvements in breastfeeding rates have been observed over the past decade, which highlights the need for accelerating breastfeeding promotion interventions.

Objective: The objective of this article is to update evidence on the effect of interventions on early initiation of and exclusive (<1 and 1–5 mo) and continued (6–23 mo) breastfeeding rates in LMICs when delivered in health systems, in the home or in community environments, or in a combination of settings.

Methods: A systematic literature search was conducted in PubMed, Cochrane, and CABI databases to identify new articles relevant to our current review, which were published after the search date of our earlier meta-analysis (October 2014). Nine new articles were found to be relevant and were included, in addition to the other 52 studies that were identified in our earlier meta-analysis. We reported the pooled ORs and corresponding 95% CIs as our outcome estimates. In cases of high heterogeneity, random-effects models were used and causes were explored by subgroup analysis and meta-regression.

Results: Early initiation of and exclusive (<1 and 1–5 mo) and continued (6–23 mo) breastfeeding rates in LMICs improved significantly as a result of interventions delivered in health systems, in the home or community, or a combination of these. Interventions delivered concurrently in a combination of settings were found to show the largest improvements in desired breastfeeding outcomes. Counseling provided in any setting and baby-friendly support in health systems appear to be the most effective interventions to improve breastfeeding.

Conclusions: Improvements in breastfeeding practices are possible in LMICs with judicious use of tested interventions, particularly when delivered in a combination of settings concurrently. The findings can be considered for inclusion in the Lives Saved Tool model.

Sinha, B, et al. 2017. “Low-birthweight infants born to short-staturemothers are at additional risk of stunting and poor growth velocity: Evidencefrom secondary data analyses”. Matern Child Nutr 14 (1). Publisher's VersionAbstract

Low-birthweight (LBW) infants are at an increased risk of stunting and poor linear growth. The risk might be additionally higher in these infants when born to short mothers. However, this hypothesis has been less explored. The objective of this secondary data analysis was to determine the risk of linear growth faltering and difference in linear growth velocity in LBW infants born to short mothers (<150 cm) compared to those born to mothers with height ≥150 cm during the first year of life. This analysis uses data from a community-based randomized controlled trial of 2,052 hospital-born term infants with birthweight ≤2,500g from urban low–middle socioeconomic neighbourhoods in Delhi, India. Data on maternal height and infant birth length were available from 1,858 (90.5%) of the infants. Infant anthropometry outcomes were measured at birth, 3, 6, 9, and 12 months of age. We found that infants born to short mothers had around twofold higher odds of stunting and lower attained length-for-age Z scores compared to infants of mothers with height ≥150 cm, at all ages of assessment. Linear growth velocity was significantly lower in infants of short mothers particularly in the first 6 months of life. We conclude that LBW infants born to short mothers are at a higher risk of stunting and have slower postnatal growth velocity resulting in lower attained length-for-age Z scores in infancy. Evidence-based strategies need to be tested to optimize growth velocity in LBW infants especially those born to short mothers.

Welch, VA, et al. 2017. “CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials”. BMJ. Publisher's VersionAbstract

We outline CONSORT-Equity 2017 reporting standards, an extension to the CONSORT (Consolidated Standards of Reporting Trials) statement that aims to improve the reporting of intervention effects in randomised trials where health equity is relevant. Health inequities are unfair differences in health that can be avoided by reasonable action. We defined a randomised trial where health equity is relevant as one that assesses effects on health equity by evaluating an intervention focused on people experiencing social disadvantage or by exploring the difference in the effect of the intervention between two groups (or as a gradient across more than two groups) experiencing different levels of social disadvantage, or both. We held a consensus meeting with diverse potential users from high, middle, and low income countries, including knowledge users such as patients and methodologists. We discussed evidence for each proposed extension item from empirical studies, reviews, key informant interviews, and an online survey, aiming to improve clarity of reporting without imposing undue burden on authors. The new guidance contains equity extensions to 16 items from CONSORT 2010 plus one new item on research ethics reporting, with examples of good practice and a brief explanation and elaboration for each. Widespread uptake of this guidance for the reporting of trials where health equity is relevant will make it easier for decision makers to find and use evidence from randomised trials to reduce unfair inequalities in health.

Onarheim, KH, et al. 2017. “What if the baby doesn't survive? Health-care decision making for ill newborns in Ethiopia”. Social Science & Medicine. Publisher's VersionAbstract

Despite efforts to improve access to and quality of care for newborns, the first month after birth remains the most dangerous period of life. Given high neonatal mortality in low-income countries, saving newborn lives is a key priority for global and national health policy agendas. However, little is known about how these policies resonate with local understandings, experiences and household priorities. In this qualitative study we examined families' decision making and health-care-seeking in Butajira, Ethiopia. Data were collected through observation in hospital, in-depth interviews (41), and focus group discussions (7) with family members, health-care workers, and community members (October–November 2015). Transcripts and field notes were analyzed inductively using qualitative content analysis. Findings indicate that newborn health was not always the family's priority. Local perceptions of newborns as not yet useful members of the household alongside costly health-care services delayed decision making and care-seeking. While sickness was recognized as dangerous for the ill newborn, seeking health-care could be harmful for the economic survival of the family. In a resource-constrained setting, families' focused on productive assets in order to minimize long-term risks, and waited before seeking newborn health-care services. Until the baby had survived the first vulnerable weeks and months of life, the unknown newborn was not yet seen as a social person by the community. Personhood evolved progressively as the baby became a part of the family. A newborn death was surrounded by silence, and families received minimal support from traditional financial associations, iddirs. Decisions regarding health-care were contingent upon families' understandings of newborns and their resource-constrained circumstances. Improving newborn health involves recognizing why families choose to (not) seek health-care, and their actual opportunities and constraints in making such decisions. The everyday realities of vulnerable newborns must be at the center of global and national policy discussions and local implementation.

Keywords: EthiopiaNewborn healthHealth-care-seekingDecision makingPersonhoodPovertyQualitative research

Katirayi, L, et al. 2017. “Echoes of old HIV paradigms: reassessing the problem of engaging men in HIV testing and treatment through women's perspectives”. Reproductive Health. Article in PumedAbstract

BACKGROUND: With the introduction of 2016 World Health Organization guidelines recommending universal antiretroviral therapy (ART), there has been increased recognition of the lack of men engaging in HIV testing and treatment. Studies in sub-Saharan Africa indicate there have been challenges engaging men in HIV testing and HIV-positive men into treatment.


METHODS:This qualitative study explored women's perspective of their male partner's attitudes towards HIV and ART and how it shapes woman's experience with ART. Data were collected through in-depth interviews and focus group discussions with HIV-positive pregnant and postpartum women on Option B+ and health care workers in Malawi and Zimbabwe. In Malawi, 19 in-depth interviews and 12 focus group discussions were conducted from September-December 2013. In Zimbabwe, 15 in-depth interviews and 21 focus-group discussions were conducted from July 2014-March 2014.


RESULTS:The findings highlighted that many men discourage their partners from initiating or adhering to ART. One of the main findings indicated that despite the many advancements in HIV care and ART regimens, there are still many lingering negative beliefs about HIV and ART from the earlier days of the epidemic. In addition to existing theories explaining men's resistance to/absence in HIV testing and treatment as a threat to their masculinity or because of female-focused health facilities, this paper argues that men's aversion to HIV may be a result of old beliefs about HIV and ART which have not been addressed.


CONCLUSIONS: Due to lack of accurate and up to date information about HIV and ART, many men discourage their female partners from initiating and adhering to ART. The effect of lingering and outdated beliefs about HIV and ART needs to be addressed through strengthened communication about developments in HIV care and treatment. Universal ART offers a unique opportunity to curb the epidemic, but successful implementation of these new guidelines is dependent on ART initiation and adherence by both women and men. Strengthening men's understanding about HIV and ART will greatly enhance women's ability to initiate and adhere to ART and improve men's health.


KEYWORDS: ART initiation; Africa; HIV; Lifelong treatment; Male engagement; PMTCT; Qualitative; Universal treatment

Hailu, A, et al. 2017. “Economic burden of malaria and predictors of cost variability to rural households in south-central Ethiopia”. Plos One. Article in PumedAbstract

BACKGROUND: While recognizing the recent remarkable achievement in the global malaria reduction, the disease remains a challenge to the malaria endemic countries in Africa. Beyond the huge health consequence of malaria, policymakers need to be informed about the economic burden of the disease to the households. However, evidence on the economic burden of malaria in Ethiopia is scanty. The aims of this study were to estimate the economic burden of malaria episode and to identify predictors of cost variability to the rural households.

METHODS:A prospective costing approach from a household perspective was employed. A total of 190 malaria patients were enrolled to the study from three health centers and nine health posts in Adami Tullu district in south-central Ethiopia, in 2015. Primary data were collected on expenditures due to malaria, forgone working days because of illness, socioeconomic and demographic situation, and households' assets. Quantile regression was applied to predict factors associated with the cost variation. Socioeconomic related inequality was measured using concentration index and concentration curve.


RESULTS: The median cost of malaria per episode to the household was USD 5.06 (IQR: 2.98-8.10). The direct cost accounted for 39%, while the indirect counterpart accounted for 61%. The history of malaria in the last six months and the level of the facility visited in the health system predominantly influenced the direct cost. The indirect cost was mainly influenced by the availability of antimalarial drugs in the health facility. The concentration curve and the concentration index for direct cost indicate significant pro-rich inequality. Plasmodium falciparum is significantly more costly for households compared to Plasmodium vivax.


CONCLUSION:The economic burden of malaria to the rural households in Ethiopia was substantial-mainly to the poor-indicating that reducing malaria burden could contribute to the poverty reduction as well.

Jull, J, et al. 2017. “When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework”. BMJ Open. Publisher's VersionAbstract

Background Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials.

Methods An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials.

Results A randomised trial can usefully be classified as ‘health equity relevant’ if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as ‘health equity relevant’ may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies.

Conclusion The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity.

  • health
  • equity
  • randomized controlled trials
  • framework

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

Chowdhury, R, et al. 2017. “Gender differences in infant survival: A secondary data analysis in rural North India”. BMJ Open 7. Publisher's VersionAbstract

Objective To examine gender differences in infant survival on the first day of life, in the first week of life, and in the neonatal and post-neonatal periods by socio-demographic and economic variables.

Design Secondary data analysis was performed on data from a cluster randomised trial on the effect of implementation of the Integrated Management of Neonatal and Childhood Illness programme, India.

Settings The study setting was Palwal and Faridabad, districts of Haryana, a state in North India.

Measures Multiple logistic regression models taking the cluster design into account were used to estimate gender differences in mortality in different periods of infancy.

Results A total of 60 480 infants were included in these analyses. Of 4060 infant deaths, 2054 were female (7.2% of all females born) and 2006 were male (6.3% of all males born). The death rate was significantly higher in females in the post-neonatal period but not during the neonatal period. The odds of death at 29–180 days and at 181–365 days were 1.4 (95% CI 1.3 to 1.6) and 1.7 (95% CI: 1.4 to 2.0) higher in females compared with males, respectively. This increase was seen across all socio-demographic and economic strata.

Conclusion Gender differences during the post-neonatal period are a major threat to the survival and health of female infants in India. Programmes need to identify measures that can specifically reduce female mortality.

Nankabirwa, V, et al. 2017. “Efficacy of umbilical cord cleansing with a single application of 4% chlorhexidine for the prevention of newborn infections in Uganda: study protocol for a randomized controlled trial.”. Trials. Article in Pubmed Abstract

BACKGROUND: Yearly, nearly all the estimated worldwide 2.7 million neonatal deaths occur in low- and middle-income countries. Infections, including those affecting the umbilical cord (omphalitis), are a significant factor in approximately a third of these deaths. In fact, the odds of all-cause mortality are 46% higher among neonates with omphalitis than in those without. Five large randomized controlled trials in Asia and Sub-Saharan Africa (SSA) have examined the effect of multiple cord stump applications with 4% chlorhexidine (CHX) for at least 7 days on the risk of omphalitis and neonatal death. These studies, all community-based, show that multiple CHX applications reduced the risk of omphalitis. Of these trials, only one study from South Asia (the Bangladeshi study) and none from Africa examined the effect of a single application of CHX as soon as possible after birth. In this Bangladeshi trial, CHX led to a reduction in the risk of mild-moderate omphalitis and neonatal death. It is important, in an African setting, to explore the effect of a single application among health-facility births. A single application is programmatically much simpler to implement than daily applications for 7 days. Therefore, our study compares umbilical cord cleansing with a single application of 4% CHX at birth with dry cord care among Ugandan babies born in health facilities, on the risk of omphalitis and severe neonatal illness.


METHODS: The CHX study is a facility-based, individually randomized controlled trial that will be conducted among 4760 newborns in Uganda. The primary outcomes are severe illness and omphalitis during the neonatal period. Analysis will be by intention-to-treat.

DISCUSSION: This study will provide novel evidence, from a Sub-Saharan African setting, of the effect of umbilical cord cleansing with a single application of 4% CHX at birth and identify modifiable risk factors for omphalitis.

TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02606565. Registered on 12 November 2015.

KEYWORDS: Chlorhexidine; Neonatal; Newborn; Omphalitis; Severe illness; Trial

Mazumder, S, et al. 2017. “Impact of community-initiated Kangaroo Mother Care on survival of low birth weight infants: study protocol for a randomized controlled trial.”. Trials. Article in Pubmed Abstract

BACKGROUND: Around 70% neonatal deaths occur in low birth weight (LBW) babies. Globally, 15% of babies are born with LBW. Kangaroo Mother Care (KMC) appears to be an effective way to reduce mortality and morbidity among LBW babies. KMC comprises of early and continuous skin-to-skin contact between mother and baby as well as exclusive breastfeeding. Evidence derived from hospital-based studies shows that KMC results in a 40% relative reduction in mortality, a 58% relative reduction in the risk of nosocomial infections or sepsis, shorter hospital stay, and a lower risk of lower respiratory tract infections in babies with birth weight <2000 g. There has been considerable interest in KMC initiated outside health facilities for LBW babies born at home or discharged early. Currently, there is insufficient evidence to support initiation of KMC in the community (cKMC). Formative research in our study setting, where 24% of babies are born with LBW, demonstrated that KMC is feasible and acceptable when initiated at home for LBW babies. The aim of this trial is to determine the impact of cKMC on the survival of these babies.


METHODS/DESIGN: This randomized controlled trial is being undertaken in the Palwal and Faridabad districts in the State of Haryana, India. Neonates weighing 1500-2250 g identified within 3 days of birth and their mothers are being enrolled. Other inclusion criteria are that the family is likely to be available in the study area over the next 6 months, that KMC was not initiated in the delivery facility, and that the infant does not have an illness requiring hospitalization. Eligible neonates are randomized into intervention and control groups. The intervention is delivered through home visits during the first month of life by study workers with a background and education similar to that of workers in the government health system. An independent study team collects mortality and morbidity data as well as anthropometric measurements during periodic home visits. The primary outcomes of the study are postenrollment neonatal mortality and mortality between enrollment and 6 months of age. The secondary outcomes are breastfeeding practices; prevalence of illnesses and care-seeking practices for the same; hospitalizations; weight and length gain; and, in a subsample, neurodevelopment.


DISCUSSION: This efficacy trial will answer the question whether the benefits of KMC observed in hospital settings can also be observed when KMC is started in the community. The formative research used for intervention development suggests that the necessary high level of KMC adoption can be reached in the community, addressing a problem that seriously constrained conclusions in the only other trial in which researchers examined the benefits of cKMC.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02653534. Registered on 26 December 2015 (retrospectively registered).

KEYWORDS: Community-initiated Kangaroo Mother Care; Low birth weight babies; Mortality

Sanou, AS, et al. 2017. “Maternal alcohol consumption during pregnancy and child's cognitive performance at 6-8 years of age in rural Burkina Faso: an observational study”. Peer J. Article in Pubmed Abstract

BACKGROUND: In Burkina Faso, it is not uncommon for mothers to drink alcohol, even during pregnancy. We aimed to study the association between maternal alcohol consumption during pregnancy and the child's cognitive performance using the Kaufman Assessment Battery for Children, 2nd edition (KABC-II) and the Children's Category Test Level 1 (CCT-1) in rural Burkina Faso.


METHODS:We conducted a follow-up study of a community cluster-randomised Exclusive breastfeeding trial, and re-enrolled the children in rural Burkina Faso. A total of 518 children (268 boys and 250 girls) aged 6-8 years were assessed using the KABC-II and the CCT-1. We examined the effect size difference using Cohen's d and conducted a linear regression analysis to examine the association.


RESULTS: Self-reported alcohol consumption during pregnancy was 18.5% (96/518). Children whose mothers reported alcohol consumption during pregnancy performed significantly poorly for memory and spatial abilities tests from small effect size difference for 'Atlantis' (0.27) and 'Triangle' (0.29) to moderate effect size difference for 'Number recall' (0.72) compared to children whose mothers did not consume alcohol during pregnancy; the exposed children scored significantly higher errors with a small effect size (0.37) at problem solving (CCT-1) test compared to unexposed children. At unstandardized and standardized multivariable analysis, children whose mothers reported alcohol consumption during pregnancy performed significantly poorer for memory-'Atlantis' (p = 0.03) and 'Number recall' (p = 0.0001), and spatial ability tests-'Triangle' (p = 0.03); they scored significantly higher errors at problem solving CCT-1 test (p = 0.002); all the results were adjusted for age, sex, schooling, stunting, father's education, mother's employment and the promotion of exclusive breastfeeding. No statistical association was found for visual abilities-'Conceptual Thinking', 'Face recognition', 'Story completion', and reasoning tests-'Rover', 'Block counting', and 'Pattern Reasoning'.


CONCLUSION: Maternal alcohol consumption during pregnancy is associated with poorer cognitive performance for memory, spatial ability, and problem solving tests in the offspring in rural Burkina Faso. Futures studies needs to assess in more detail the maternal alcohol consumption patterns in Burkina Faso and possible preventive strategies.


KEYWORDS: Africa; Burkina Faso; CCT-1; Child development; Children; Cognitive test; KABC-II; Maternal alcohol consumption; Pregnancy

Haugen, J, et al. 2017. “Vitamin D status is associated with treatment failure and duration of illness in Nepalese children with severe pneumonia.”. Pediatric Research. Article in Pubmed Abstract

BACKGROUND: There is no consensus on optimal Vitamin D status. The objective of this study was to estimate the extent to which vitamin D status predicts illness duration and treatment failure in children with severe pneumonia by using different cut-offs for vitamin D concentration.

METHODS: We measured the plasma-concentration of 25(OH)D in 568 children hospitalized with WHO-defined severe pneumonia. The associations between vitamin D status, using the most frequently used cut-offs of vitamin D insufficiency (25(OH)D <50 and <75 nmol/l) and risk of treatment failure and time until recovery were analysed in multiple logistic regression and Cox proportional hazards models, respectively.

RESULTS: Of the 568 children, 322 (56.7%) had plasma-25(OH)D ≥75 nmol/l, 179 (31.5%) 50-74.9 nmol/l and 67 (%) <50 nmol/l. Plasma-25(OH)D <50 nmol/l was associated with increased risk of treatment failure and longer time until recovery.

CONCLUSION: Our findings indicate that low vitamin D status (25(OH)D <50 nmol/l) is an independent risk factor for treatment failure and delayed recovery of severe lower respiratory infections in children.

TRIAL REGISTRATION: NCT00252304.Pediatric Research accepted article preview online, 05 July 2017. doi:10.1038/pr.2017.71.

Wadhwa, N, et al. 2017. “Zinc as an adjunct treatment for reducing case fatality due to clinical severe infection in young infants: study protocol for a randomized controlled trial”. BMC Pharmacology and Toxicology. Article in Pubmed Abstract

BACKGROUND: An estimated 2.7 of the 5.9 million deaths in children under 5 years of age occur in the neonatal period. Severe infections contribute to almost a quarter of these deaths. Mortality due to severe infections in developing country settings is substantial despite antibiotic therapy. Effective interventions that can be added to standard therapy for severe infections are required to reduce case fatality.
METHODS/DESIGN:
This is a double-blind randomized placebo-controlled parallel group superiority trial to investigate the effect of zinc administered orally as an adjunct to standard therapy to infants aged 3 days up to 2 months (59 days) hospitalized with clinical severe infection, that will be undertaken in seven hospitals in Delhi, India and Kathmandu, Nepal. In a 1:1 ratio, we will randomly assign young infants to receive 10 mg of elemental zinc or placebo orally in addition to the standard therapy for a total of 14 days. The primary outcomes hospital case fatality, which is death due to any cause and at any time after enrolment while hospitalized for the illness episode, and extended case fatality, which encompasses the period until 12 weeks after enrolment.


DISCUSSION: A previous study showed a beneficial effect of zinc in reducing the risk of treatment failure, as well as a non-significant effect on case fatality. This study was not powered to detect an effect on case fatality, which this current study is. If the results are consistent with this earlier trial, we would have provided strong evidence for recommending zinc as an adjunct to standard therapy for clinical severe infection in young infants.


TRIAL REGISTRATION: Universal Trial Number: U1111-1187-6479, Clinical Trials Registry - India: CTRI/2017/02/007966 : Registered on February 27, 2017.


KEYWORDS: India; Infants; Neonate; Nepal; Sepsis; Severe infection; Zinc

Birungi, N, et al. 2017. “Assessing causal effects of early life-course factors on early childhood caries in 5-year-old Ugandan children using directed acyclic graphs (DAGs): A prospective cohort study.”. Community Dental and Oral Epidemiology. Article in PubMedAbstract

OBJECTIVE:To estimate the effect of distal and proximal early life-course factors on early childhood caries (ECC) in 5-year-old Ugandan children, particularly focusing on the causal effect of exclusive breast feeding (EBF) on ECC using directed acyclic graphs (DAGs) for confounder selection.

METHODS:This study had a nested prospective cohort design, focusing on 5 years of follow-ups of caregiver-children pairs from the PROMISE-EBF trial (ClinicalTrials.gov no: NCT00397150) conducted in 2011 in Eastern Uganda. Data were from recruitment interviews, 24-week, 2-year and 5-year follow-ups of a cohort of 417 mother-children pairs. Trained research assistants performed interviews with caregivers in the local language and ECC was recorded under field conditions using the World Health Organization's (WHO) decayed missing or filled teeth (dmft) index. Early life-course factors in terms of socio-demographic characteristics, EBF and other feeding habits were assessed at the various follow-ups. The outcome (ECC; dmft>0) was assessed at the 5-year follow-up. Causal diagrams as DAGs were constructed to guide the selection of confounding and collider variables to be included in or excluded from the final multivariable analysis. Negative binomial regression analyses were performed based on two comparative DAGs representing different causal models.

RESULTS:Model 1 based on DAG 1, showed EBF to be a protective factor against ECC, with an IRR and 95% CI of 0.62 (0.43-0.91). According to Model 2 based on DAG 2, EBF and having both parents living together had protective effects: the corresponding IRRs and 95% CI were 0.60 (0.41-0.88) and 0.48 (0.25-0.90), respectively.

CONCLUSIONS:Both plausible models indicated that being exclusively breastfed for 24 weeks had a protective causal effect against ECC. Further research, examining the unmeasured variables included in the DAGs is necessary to strengthen the present finding and allow stronger causal claims.

OBJECTIVE:

To estimate the effect of distal and proximal early life-course factors on early childhood caries (ECC) in 5-year-old Ugandan children, particularly focusing on the causal effect of exclusive breast feeding (EBF) on ECC using directed acyclic graphs (DAGs) for confounder selection.

METHODS:

This study had a nested prospective cohort design, focusing on 5 years of follow-ups of caregiver-children pairs from the PROMISE-EBF trial (ClinicalTrials.gov no: NCT00397150) conducted in 2011 in Eastern Uganda. Data were from recruitment interviews, 24-week, 2-year and 5-year follow-ups of a cohort of 417 mother-children pairs. Trained research assistants performed interviews with caregivers in the local language and ECC was recorded under field conditions using the World Health Organization's (WHO) decayed missing or filled teeth (dmft) index. Early life-course factors in terms of socio-demographic characteristics, EBF and other feeding habits were assessed at the various follow-ups. The outcome (ECC; dmft>0) was assessed at the 5-year follow-up. Causal diagrams as DAGs were constructed to guide the selection of confounding and collider variables to be included in or excluded from the final multivariable analysis. Negative binomial regression analyses were performed based on two comparative DAGs representing different causal models.

RESULTS:

Model 1 based on DAG 1, showed EBF to be a protective factor against ECC, with an IRR and 95% CI of 0.62 (0.43-0.91). According to Model 2 based on DAG 2, EBF and having both parents living together had protective effects: the corresponding IRRs and 95% CI were 0.60 (0.41-0.88) and 0.48 (0.25-0.90), respectively.

CONCLUSIONS:

Both plausible models indicated that being exclusively breastfed for 24 weeks had a protective causal effect against ECC. Further research, examining the unmeasured variables included in the DAGs is necessary to strengthen the present finding and allow stronger causal claims.

Ogutto, DW, et al. 2017. “Rapid reduction of malaria following introduction of vector control interventions in Tororo District, Uganda: a descriptive study.”. Malaria Journal. Article in PubmedAbstract

BACKGROUND:

In 2012, Tororo District had the highest malaria burden in Uganda with community Plasmodium prevalence of 48%. To control malaria in the district, the Ministry of Health introduced universal distribution of long lasting insecticide-treated nets (LLINs) in 2013 and added indoor residual spraying (IRS) in 2014. This study assessed malaria incidence, test positivity rates and outpatient (OPD) attendance due to malaria before and after vector control interventions.

METHODS:

This study was based on analysis of Health Management Information System (HMIS) secondary malaria surveillance data of 2,727,850 patient records in OPD registers of 61 health facilities from 2012 to 2015. The analysis estimated monthly malaria incidence for the entire population and also separately for <5- and ≥5-year-olds before and after introduction of vector control interventions; determined laboratory test positivity rates and annual percentage of malaria cases in OPD. Chi square for trends was used to analyse annual change in malaria incidence and logistic regression for monthly reduction.

RESULTS:

Following universal LLINs coverage, the annual mean monthly malaria incidence fell from 95 cases in 2013 to 76 cases per 1000 in 2014 with no significant monthly reduction (OR = 0.99, 95% CI 0.96-1.01, P = 0.37). Among children <5 years, the malaria incidence reduced from 130 to 100 cases per 1000 (OR = 0.98, 95% CI 0.97-1.00, P = 0.08) when LLINs were used alone in 2014, but declined to 45 per 1000 in 2015 when IRS was combined with LLINs (OR = 0.94, 95% CI 0.91-0.996, P < 0.0001). Among individuals aged ≥5 years, mean monthly malaria incidence reduced from 59 to 52 cases per 1000 (OR = 0.99, 95% CI 0.97-1.02, P = 0.8) when LLINs were used alone in 2014, but reduced significantly to 25 per 1000 in 2015 (OR = 0.91, 95% CI 0.88-0.94, P < 0.0001). Malaria test positivity rate reduced from 57% in 2013 to 30% (Chi = 15, P < 0.0001) in 2015. Slide positivity rate reduced from 45% in 2013 to 21% in 2015 (P = 0.004) while RDT positivity declined from 69 to 40%.

CONCLUSIONS:

A rapid reduction in malaria incidence was observed in Tororo District following the introduction of IRS in addition to LLINs. There was no significant reduction in malaria incidence following universal distribution of LLINs to communities before introduction of IRS.

KEYWORDS:

Control; Incidence; Malaria; Reduction; Vector

Pay, ASD, et al. 2017. “Symphysis-fundus measurement - the predictive value of a new reference curve.”. Tidsskrift for den norske legeforening. Article in Pubmed

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