From the webpage:

Introduction

This booklet is compiled annually to summarize the evidence on child health derived from randomized trials in developing countries over the previous year. The aim is to make this information widely available to paediatricians, nurses, other health workers and administrators in resource poor settings where up-to-date information is hard to find. It is hoped that such information will be helpful in reviewing treatment policies, clinical practice and public health strategies.

The method of searching for studies to include uses Pubmed, a search engine that is freely available and widely used in most countries throughout the world. The search strategy has been chosen to try to capture as many relevant studies as possible, although it is possible that some are missed. If you know of a relevant RCT that has not been included in this year’s review, please let me know. The search strategy is reproducible by anyone with access to the Internet, through http://www.ncbi.nlm.nih.gov/entrez/query.fcgi

Randomized controlled trials (RCTs) are far from the only valuable scientific evidence, and some RCTs, because of problems with design or implementation have limited value. However the method of the Randomized Trial is the Gold Standard for determining attributable benefit or harm from clinical and public health interventions. When appropriately performed they eliminate bias and confounding. However their results should not be accepted uncritically and they should be evaluated for quality and validity. Before the result of an RCT can be generalized to another setting there must be consideration of the wider applicability, feasibilityand potential for sustainability.

This year 179 studies were identified. These came from all regions of the world, mostly from developing country researchers. Several trials from 2009-10 will lead to significant changes in child health approaches or clinical recommendations.

We have included the web-link for papers that are freely available in full-text on the Internet.

More importantly, through HINARI (http://www.who.int/hinari/en/) a program set up by WHO in collaboration with major publishers, the full-text version of over 7000 journal titles are now available to health institutions in 109 countries. If your health institution (medical school, teaching hospital, nursing school, government office) has not registered with HINARI, you can check your eligibility and register online.

Please feel free to distribute this booklet to any colleagues. Previous editions (2002-2008) are available at: www.ichrc.org

Five trials reported significant reductions in mortality (marked with *** in the booklet),

Among these:

 In Ethiopia, the mass administration of a single dose of azithromycin (20mg/kg), to control trachoma, resulted in a halving of mortality among children 1-9 years of age, presumably because of an effect on reducing deaths from other common infections causing deaths. For reaching MDG-4 targets, this is arguably the most innovative and practice changing result for the year, and needs to be reproduced in other settings.

• Meta-analysis of RCTs commencing ‘Kangaroo Mother Care’ in the first week of life in Columbia, India and Ethiopia showed a significant reduction in neonatal mortality [relative risk (RR) 0.49, 95% confidence interval (CI) 0.29-0.82] compared with standard care.

• In India, a large study of community-based women’s groups that supported strategies to address maternal and newborn health problems significantly reduced neonatal mortality over a 3 year period. The same effect was not seen in a similar study in Bangladesh.

Randomised trials in child health in developing countries 2009-10

Some of the other important outcomes from studies in 2009-10 include:

• In South Africa short-term multi-micronutrient supplementation significantly reduced the duration of pneumonia or diarrhea in hospitalised HIV-infected children

• A home stimulation programme taught to caregivers can significantly improve cognitive and motor development in young children infected with HIV, and rehabilitation for children with cerebral malaria can also have a significant benefit on neurocognitive function

• Single dose nevirapine is associated with development of resistance to non-nucleoside reverse transcriptase inhibitor drugs. A short course of AZT plus 3TC, supplementing maternal and infant single-dose nevirapine, reduces resistance mutations in both mothersand infants

• Among HIV-infected women in Tanzania, multivitamins taken in the antenatal period and continued after delivery reduced the risk of low birth weight and infant mortality, but the effect was much stronger for girl babies than boys

• In South Africa and Malawi rotavirus vaccine significantly reduced the incidence of severe rotavirus gastroenteritis during the first year of life

• Insecticide treated bed nets can be coupled with weekly bacterial larvicide distribution in bodies of water to effectively tackle the adult and larval forms of malaria vector

• Having simple screens on doors and windows reduced rates of anaemia in malaria endemic area in Gambia.

• Three studies involving eight African countries found that dihydroartemisininpiperaquine (DP) is as safe and effective as artemether-lumefantrine (AL) in the treatment of uncomplicated falciparum malaria, and 2 of these studies showed lower rates of recurrence at 28 and 42 days with DP, suggesting a longer term prophylactic effect than with AL. DP was also shown to be effective in the treatment of vivax malaria

• In settings where G6PD deficiency is common chlorproguanil-dapsone and its combinations with artesunate, used as intermittent preventative treatment or as treatment for clinical malaria results in a high risk of haemolysis. Three RCTs this year highlighted this complication, and further development of this drug has now ceased.

• Delaying BCG vaccination from birth to 10 weeks of age enhances the quantitative and qualitative BCG-specific T cell response, when measured at 1 year of age. In Guinea-Bissau, mortality was higher among children who received a booster dose of DTP after BCG vaccination

• In India, in the treatment of visceral leishmaniasis a single infusion of liposomal amphotericin B was not inferior to and was less expensive than 15 infusions of amphotericin B deoxycholate over one month.

Trevor Duke

July 2010