SCALE-8, Stimulation of Children And effects on Learning and Education at 8 years

More than 250 million children living in low- and middle-income countries (LMIC) are not achieving their development potential due to biological, psychosocial and environmental risks for poor early development. These could be inadequate stimulation, malnutrition, infectious illnesses, maternal depression and societal violence. The current study is a follow up on a previous project which assessed the effectiveness, feasibility and cost of integrated early stimulation and nutrition interventions in a government community-based health service. The initial study reported significant impact on children’s development at age 2 years. These gains were sustained at age 4 years although with smaller impact. There are however limited evidence of the enduring effects of protective early childhood interventions that promote development on later life outcomes in LMIC. This is something the present study aims to mitigate. Here children will be re-enrolled at age 8 years to determine beneficial effects on learning, behavior and growth that have endured to school age. These data will provide insights on whether there are any sustained benefits, whether any sub-group of children have benefitted more or less from the exposure to early interventions. The data will also identify risks and protective factors in the child’s life course that are influencing outcomes to inform intervention development

PMT: Muneera A Rasheed/Aisha K Yousafzai

Country: Pakistan

eRegistries: Electronic registries to improve quality of maternal and child healthcare in Palestine

Better data on health status and quality of healthcare are crucial to address bottlenecks in achieving universal health coverage and producing better policies for health. eRegistries are designed to maximize data use and address common challenges of health information systems so that data is consistently and methodically utilized to inform decision-making. The Palestinian National Institute of Public Health is, in close collaboration with the Ministry of Health in Palestine, currently rolling out a nationwide electronic registry for maternal and new-born health. The eRegistry serves the dual purpose of patient management and public health monitoring. The research in Palestine led by the Norwegian Institute of Public Health, is embedded within the national implementation of eRegistries for maternal and child health. The studies are conducted as cluster randomized trials, designed and monitored in collaboration with CISMAC. Research topics include integrated clinical decision and workflow support, feedback and benchmarking of care providers for improving quality of care, tailored text messages to women and behaviour change communication. The framework of research is nested within the US Institute of Medicine’s domains of quality of care; safety, effectiveness, patient-centeredness, timeliness, efficiency and equity (

PMT: Mahima Venkateswaran/Frederik Frøen/Kjersti Mørkrid
Country: Palestine

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Delayed BCG vaccination in HIV infants in Uganda

It is possible that BCG vaccination at birth can protect infants against several serious infections, not only against tuberculosis.  Randomized control trials are required to inform the development of strategies for BCG vaccination by measuring whether deferring BCG vaccination from birth to 14 weeks of age    changes immune responses to BCG and the risk of serious illness during the first two years of life. The first draft Study Protocol for this study is being completed.

PMT: Victoria Nankabirwa / Halvor Sommerfelt

Country: Uganda
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The use of Chlorhexidine in umbilical cord cleansing to prevent infections in newborns in Uganda.

Ninety-eight percent of the approximately 3.3 million deaths in the first 28 days of life occur in low and middle income countries (LMICs), yearly. A third of these are associated with infections and this proportion rises in areas where at least half of the births occur at home like in Uganda. Infection of the umbilical cord stump (omphalitis) is a major contributor to these infections. Before it detaches, the stump poses high risk of infection to the newborn. Several interventions have been recommended to combat newborn infections including full body skin cleansing with antiseptics like chlorhexidine, hand washing with soap and water and use of clean birth kits. The effect of these interventions are unclear, however the use of chlorhexidine shows the most promise. This study examines how a single chlorhexidine application on the umbilical chord impacts infections in newborns.

PMT: Victoria Nankabirwa / Halvor Sommerfelt
Country: Uganda

Education and empowerment of adolescent girls to reduce teenage childbearing in Zambia

Studies in low and middle income countries show an association between low educational attainment and risky sexual behaviour, early marriage and pregnancies. Teenage pregnancies are associated with high risk of preterm birth, and unplanned pregnancies may be terminated by unsafe abortion, with its inherent risks. Increasing age at first pregnancy and birth is therefore likely to translate into improved maternal and child health. The net attendance in primary and secondary school for rural girls in Zambia is 77% and 20%, respectively. Together with Zambian authorities and the WHO the Project Management Team of our planned CISMAC study explores the possibility of evaluating the impact of an intervention to promote education and empowerment of Zambian adolescent girls. In the latter half of 2013, the key investigators made field trips to a number of rural primary schools and interacted with teachers and parents. They are developing plans for the necessary formative research to inform intervention design.

PMT: Patrick Musonda / Ingvild Sandøy
Country: Zambia

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Impact of Kangaroo Mother Care (KMC) with support for low birth weight infants in India

Low birth weight infants account for 60-80% of all neonatal deaths. However, over 75% of deaths among these infants could be prevented even without access to intensive care.  Providing low birth weight babies the necessary care in the community could make a major contribution to enhancing neonatal survival, particularly in India where over 25% of infants are born with low birth weight. This study aims to develop and evaluate an intervention package based on the promotion of KMC in the community. It is being developed in collaboration with the WHO and will be conducted in two stages. The first stage will consist of formative research to design and develop an intervention package and pilot test it to assess its acceptability among mothers of low birth weight babies. The second stage will be a randomized controlled trial to ascertain the impact of community based KMC on survival of low birth weight infants during the neonatal period and in the first 6 month of life. The state government of Haryana, India, is a partner in this effort.

PMT: Sarmila Mazumder / Sunita Taneja / Halvor Sommerfelt
Country: India

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Supplementation with high doses of vitamin B12 in pregnancy and in infancy to improve cognitive functioning in early childhood in Nepal

Many women and children in LMIC have inadequate vitamin B12 status. Vitamin B12is crucial for normal cell division and differentiation and vitamin B12deficiency is associated with impaired fetal growth, premature birth as well as suboptimal brain development and function. Poor vitamin B12 status is common in people on vegetarian diets. The objective of this study is to measure the effect of supplementation with vitamin B12 on cognitive functioning in early childhood. This will be done by administrating Vitamin B12 or a placeboin pregnancy or in early childhood to 1,600 children in Nepal and then follow the children up through their early childhood. The study is in its early planning phase.

PMT: Laxman Shrestha / Ram K. ChandyoTor A. Strand
Country: Nepal
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Zinc as an adjunct for the treatment of very severe disease in young infants

The prognosis of sepsis in early infancy is poor and neonatal sepsis is an important contributor to neonatal and thereby infant mortality in LMIC. In a recent RCT in India which was anchored at the Translational Health Science and Technology Institute (THSTI), CISMAC researchers found that adjunct treatment with orally administered zinc had an efficacy of 40% against treatment failure in 7-120 days old infants with probable serious bacterial infection. The trial was not powered to estimate the effect on the babies’ case fatality risk. A proposal for a study large enough to estimate a reduction in case fatality risk has recently obtained funding from the Research Council of Norway. The Project Management Team proposed this multi-hospital trial in India and Nepal for inclusion in the CISMAC portfolio. The RCT will be anchored at the CISMAC partners THSTI in India and Institute of Medicine, Tribhuvan University in Nepal. Zinc is inexpensive and widely accessible. Should the intervention prove to be effective in increasing the survival chances of these vulnerable babies, the Study will have a significant weight in supporting the formulation of an improved treatment of sepsis and its incorporation into policy, thereby contributing to enhanced survival of young infants in LMIC.

PMT: Sudha Basnet / Nitya Wadha / Tor A. Strand
Countries: India and Nepal

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eRegistries: Strengthening the extension of reproductive maternal, newborn and child health (RMNCH) services in Bangladesh

Bangladesh has demonstrated success in reducing maternal and under-5 mortality, with reductions in newborn mortality lagging behind. The development of a new tier of community-based facilities and healthcare workers and a transition to ‘Digital Bangladesh’ are both national priorities which hope to address this concern. An eRegistry, an adaptable electronic platform for capturing, sharing and using health information to improve quality of care across the health system is being evaluated in the Matlab sub-districts of Bangladesh. This cluster-randomized controlled trial, at facility level, will compare a fully interactive eRegistry with a static electronic data entry system without any interactive features. Primary outcomes include antenatal care utilization, quality of newborn care delivered, and perinatal mortality.  Secondary outcomes include both hypertension and hemorrhage prevention, management and control.

PMT: Frederik Frøen / Anisur Rahman
Country: Bangladesh

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Competing discourses impacting girls’ and women’s rights: Fertility control and safe abortion in Ethiopia, Zambia and Tanzania

This three-year project examines global and national policy discourses surrounding fertility control and abortion, and local practices and moralities related to these issues among adolescents in Ethiopia, Zambia and Tanzania. Fertility control and safe abortion demonstrate the controversies over sexual and reproductive health policies and the gendered socio-cultural and religious norms impeding progress on girls and women’s rights.

The dynamics between the law, policies and access to fertility control and safe abortion services differ between Ethiopia, Zambia and Tanzania. All three countries have ratified the major international and regional conventions and protocols on the rights of women including the Maputo Protocol on the rights of women in Africa. Nevertheless, the three countries have very different laws regulating access to safe abortion services, reflecting their different legal histories. Judicially, abortion is legal in Zambia but illegal in Ethiopia and Tanzania. While in practice, Ethiopia is the most liberal of the three countries in terms of legal provision of safe abortion services, the case of Zambia shows that a liberal abortion law is not a sufficient condition to secure access to legal abortion. Hence, the association between the status of the law and access to safe abortion continues to be unclear, and is a central question for comparison in this research project.

PMT: Getnet Tadele/Astrid Blystad
Countries: Ethiopia, Tanzania and Zambia