Studies

Research Initiative to Support the Empowerment of girls

Adolescent pregnancies pose a risk to young mothers and their babies. In Zambia, 35% of young girls in rural areas have given birth by the age of 18. Poverty, low secondary school enrollment, myths and community norms regarding contraceptive use all contribute to early childbearing. The Research Initiative to Support the Empowerment of girls (RISE) aims to measure the effect on early childbearing rates in a rural Zambian context of (1) economic support to girls and their families, and (2) combining economic support with a community intervention to enhance knowledge about sexual and reproductive health and supportive community norms.

 

The trial has three arms, and the clusters are rural schools in twelve districts. The participants are girls who were enrolled in grade 7. The target sample size was 4,900 girls and 157 schools. Recruitment took place March-July and randomization was conducted in July 2016. The intervention period is from September 2016 to November 2018. In one intervention arm, girls and their guardians are offered economic support in the form of cash transfers and payment of school fees. In the second intervention arm, economic support is combined with community dialogue including youth club meetings (covering a sexual and reproductive health curriculum) and community meetings. The girls will be interviewed every six months, with the final interview taking place 4.5 years after recruitment. We will measure to what extent the interventions increase the proportion of girls who complete grade 9 and reduce the proportion that give birth before reaching the age of 18.

 

Of 164 schools invited to participate in the project, 157 were included and had 5,107 eligible girls of whom 4,922 assented. Thus, a very high proportion of invited schools, guardians and girls participate in our study. The findings of this trial will be highly relevant for education programmes for adolescents and for reproductive health programs in Zambia and in similar contexts.


PMT: Patrick Musonda / Ingvild Sandøy
Country: Zambia

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Impact of promoting Community initiated Kangaroo Mother Care with support for low birth weight infants in India

Babies that are born small (also called low birth weight babies), many of whom are born too early, make up nearly 80% of infant deaths. More than 75% of these deaths 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 and early infant survival. This is particularly salient in India, where over one quarter of infants are born with low birth weight. Most interventions to promote Kangaroo Mother Care (KMC) have been carried out in health facilities. This study, developed in collaboration with the WHO, aims to evaluate an intervention package based on the promotion of community initiated KMC (cKMC). The first completed stage designed and developed the intervention package and pilot tested it for feasibility and acceptability among mothers of low birth weight babies. The ongoing second stage is a randomized controlled trial of 10,500 low birth weight babies in Haryana, India, which ascertains the impact of community initiated KMC on survival of low birth weight infants during the neonatal period and in the first 6 month of life. A sub study among the first 550 children also assess for psycho-motor development. Furthermore, the bond between mother and baby is evaluated, as well as rates of maternal depression. 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 of vitamin B12 in pregnancy and postpartum on growth and cognitive functioning in early childhood

Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. The only relevant source of vitamin B12 is animal-source foods; in addition poor gut function may decrease absorption. Vitamin B12 is crucial for normal cell division and differentiation, and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In this randomized controlled trial we measure the effect of daily oral vitamin B12 supplementation to pregnant women on the neurodevelopment and growth of their children.

 

This is an individually randomized double-blind placebo controlled trial in pregnant Nepalese women at risk of poor vitamin B12 status. We will randomize 800 women in a 1:1 ratio as early as possible during pregnancy, and no later than in week 15. Enrolled women will receive 50 μg of vitamin B12, or a placebo, daily until 6 months after birth. The main outcomes of the study are neurodevelopment in children, measured at 6 and 12 months of age, and growth in children measured by weight and length at 12 months. The results of this study will inform revised dietary guidelines for South Asian women that can lead to improved pregnancy outcomes as well as improved child neurodevelopmentand cognitive functioning.

PMT: Sudha Basnet/Laxman Shestha/Tor Strand

Country:Nepal

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Early Verus Late BCG Vaccination in HIV-1 Exposed Infants

The Bacillus Calmette–Guérin (BCG) vaccine may have beneficial, so-called non-specific effects, i.e. it may protect babies from serious infections and death, a protection beyond its ability to protect them against tuberculosis (TB). However, most of the studies that indicate that BCG may have such additional non-specific effects are observational in nature and are fraught with controversy. This makes it difficult to ascertain from them whether the babies who get BCG are truly less prone to severe illness because they received the vaccine or because they had a lower risk of severe illness for other reasons. Moreover, a different set of studies indicates that giving BCG later in infancy, for example at 10 weeks of age, may enhance immune responses against the vaccine and perhaps even to non-mycobacterial antigens. This may even enhance any non-specific effects of BCG. This enhanced immunity by a deferred BCG vaccine would be particularly useful among HIV-1 exposed (HE) children who show signs of impaired immunity in early infancy and in whom the appropriate timing of BCG vaccination that maximizes protection is uncertain.

 

This study randomizes 2,200 HE Ugandan infants to receive BCG within 24 hours of being born or at 14 weeks of age. Our main study outcomes are severe illness in the first 14 weeks of life and several immunological responses to mycobacterial and non-mycobacterial antigens. The trial is conducted in three health centers in or close to Kampala. A well-timed BCG vaccination could have important additional effects in HE infants. This study could inform the development of programmatically appropriate timing of BCG vaccination for HE infants.

PMT: Victoria Nankabirwa / Halvor Sommerfelt

Country: Uganda

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Zinc as an adjunct for the treatment of very severe disease in young infants

Severe infections, including sepsis and severe pneumonia, contribute to almost one quarter of the deaths

in infants up to two months of age. This is despite available – although not always accessible – antibiotic

therapy, and the problem is likely to be aggravated as antibiotic resistance continues to spread. In a recent randomized controlled trial in India, which was anchored at the Translational Health Science and Technology Institute (THSTI), CISMAC researchers found that a daily dose of zinc given to infants aged 7 to 120

days under antibiotic treatment for probable serious bacterial infection increased the success of treatment by 43%. The trial was not powered to estimate the effect of zinc on their risk of dying. With collateral funding from RCN’s GLOBVAC programme, we are now undertaking a much larger trial, this time in infants younger than two months of age, also with clinically suspected sepsis. Enrolling 4.140 children, this trial is powered to estimate the efficacy of zinc to improve survival rates when it is given in addition to antibiotics. The trial is being undertaken in three hospitals in Nepal and four hospitals in New Delhi with CISMAC partners THSTI in India and the Institute of Medicine, Tribhuvan University in Nepal.

 

Being used routinely for treatment of children with diarrhoea, zinc is widely accessible; it is also very cheap. Should the adjunct zinc treatment prove to be effective in increasing the survival chances of these vulnerable babies, our study will provide important evidence for improving the treatment guidelines for sepsis, 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 services in Bangladesh

Bangladesh has made great progress in reducing maternal and child mortality over the last decade. Still, major gaps remain in the quality of care for mothers and children, particularly in rural areas. The ICDDR,B a research institution with a 50-year history of improving the quality of maternal and child health services, is working with the Ministry of Health to expand quality improvement approaches to government-run facilities in order to demonstrate the benefits.

 

Electronic health registries, sometimes called eRegistries, for women and children gather information on their health, and on essential care being provided across the continuum of care from the community to the health facility. Using the opportunities of electronic communication, such tools can contribute to the quality of care, share information across the various levels of care provision, and empower women and families.

 

Together, the Norwegian Institute of Public Health and the World Health Organization have developed a framework and series of tool kits to make it easier for low- and middle-income countries to improve the collection and use of health information to benefit women’s and children’s health. The present study builds on this framework to be the first of its kind to assess the benefits of this type of programme in improving the quality of care in rural Bangladesh.

PMT: Frederik Frøen / Anisur Rahman 
Country: Bangladesh


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eRegistries: Electronic registries with interactive checklist and clinical decision support to improve quality of antenatal care 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 increase the availability and timely use of routine maternal and child health (MCH) data, as data is consistently captured and the eRegistries are strategically designed to inform decisionmaking. They therefore enable care providers to perform interventions based on the client’s actual health needs, and allow for better-informed planning. Thus, eRegistries serve the dual purpose of patient management and public health monitoring.

 

The Palestinian National Institute of Public Health (PNIPH)/WHO is, in close collaboration with the Ministry

of Health in Palestine, currently rolling out a nationwide MCH eRegistry. The national implementation of the MCH eRegistry includes cluster randomized controlled trials led by the Norwegian Institute of Public Health, designed and monitored in collaboration with CISMAC. The first ongoing trial will assess if the MCH eRegistry with interactive checklists and clinical decision support can improve the quality of antenatal care. The trial includes 120 health centres (clusters). The US Institute of Medicine’s domains of quality of care, namely: safety, effectiveness, patient-centeredness, timeliness, efficiency and equity will be used to evaluate quality of care.

PMT: Frederik Frøen/Buthaina Ghanem

Country: Palestine


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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 2.7 million deaths in the first 28 days of life occur in low and middle income countries (LMICs), yearly. A third of themse are associated with infections and this proportion rises in areas where at least half of the births occur at home like Uganda. Infection of the umbilical cord stump (omphalitis) is a major contributor to these infections. The umbilical cord is cut after birth and the remaining cord stump generally dries and falls off within 5-15 days. Before it detaches, the stump provides dead tissue, and acts as an easy entry point for micro-organisms into 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. But the effects of these interventions on the incidence of infection and death in newborns are unclear.

 

Of the applications that could be used to lower the risk of newborn infections and death through appropriate cord care in LMICs, chlorhexidineapplication shows the most promise. The World Health Organization (WHO), recognizing the importance of cord care, recommends chlorhexidineit for babies born at home but not for those born at health facilities in LMICs. For these children, WHO recommends dry cord care (applying nothing to the cord but washing it with clean water when it is soiled) which is questionable given the lack of proper evidence. Moreover, there are substantial challenges in achieving appropriate hygienic practices within facilities and children born in these facilities are quickly discharged into the same community conditions as children born at home. This trial will therefore assess the effect of a single washing of the umbilical cord stump with 4% chlorhexidine in facility settings on omphalitis and severe infections. The trial enrolls 4,760 children. Receiving the bulk of its funding from the Research Council of Norway’s GLOBVAC program, it will be undertaken by researchers at the Makerere University, College of Health Science and the Centre for Interaitonal Health, University of Bergen. 

PMT: Victoria Nankabirwa / Halvor Sommerfelt
Country: Uganda

 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

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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