The Effect of a Deworming Intervention to Improve Early Childhood Growth and Development in Resource-poor Areas
Condition: Malnutrition; Intestinal Diseases, Parasitic
MeSH terms: Parasitic Diseases; Intestinal Diseases, Parasitic; Intestinal Diseases; Malnutrition
Study type: Interventional
Phase: Phase 4

Summary: 
      Worldwide, over 2 billion people suffer from worm infections in developing countries. These
      infections are especially damaging to the health of children, resulting in both short-term
      and lifelong disability. Older children with worm infections are more likely to be stunted,
      underweight, vulnerable to other illnesses and perform poorly in school compared to
      non-infected children. Large-scale deworming programs in school-age children are therefore
      recommended by the World Health Organization (WHO). WHO also recommends deworming of
      preschool-age children (as of 12 months of age) in these areas; however, the benefits of
      deworming, especially in the 12-24 month age group, have been inadequately studied. This
      knowledge is urgently needed as studies show that all children have a similar potential for
      healthy growth and development, provided that appropriate nutrition and health interventions
      are given in the critical window of opportunity before the age of two.

      Therefore, the investigators are proposing to undertake a randomized controlled trial to
      determine the effect of deworming program for improving growth and development in children
      between 12 and 24 months of age. Our results will provide solid rigorous evidence on if,
      when, and how often, deworming should be integrated into routine child health care packages
      provided by Ministries of Health in the 130 countries in the world where worm infections are
      endemic.
    

Detailed description: 
      Worldwide, over 2 billion people suffer from worm infections (hookworm, Ascaris and
      Trichuris, collectively referred to as soil-transmitted helminths (STHs)) in developing
      countries. STHs contribute to the overwhelming burden of poverty and deprivation in areas
      where adverse health, social, economic, education and other related factors predominate. STH
      infection in childhood results in short-term and lifelong disability, including malnutrition
      (e.g. underweight, stunting and wasting), cognitive impairment and increased susceptibility
      to other infection, among others. Mass deworming programs in school-age children are
      recommended by the World Health Organization (WHO). WHO also recommends deworming of
      preschool children (as of 12 months of age) in endemic areas; however, the benefits of
      deworming on improving growth and development, especially in the 12-24 month age group, have
      been inadequately studied. This knowledge is crucial because, with appropriate nutrition and
      health interventions, all children have a similar potential for healthy growth and
      development, provided that such interventions occur in the critical window of opportunity
      before the age of two.

      Therefore, this double-blind randomized controlled trial will assess the benefit of deworming
      (mebendazole), integrated into routine child health care visits in a highly STH-endemic area
      (Iquitos, Peru), on the primary outcome of weight gain. Timing, frequency and impact of
      deworming will be considered. A total of 1760 children will be recruited at their routine
      12-month check-up visit and randomly assigned to one of four intervention groups: Group 1
      will receive usual care and mebendazole (single dose 500 mg) at their 12-month visit and
      usual care and a placebo tablet at their 18-month visit; Group 2 will receive usual care and
      a placebo tablet at their 12-month visit and usual care and mebendazole at their 18-month
      visit; Group 3 will receive usual care and mebendazole at both their 12-month and 18-month
      visit; and Group 4 will receive usual care and placebo at both their 12-month and 18-month
      visit. Usual care will consist of age-appropriate immunizations, supplements and other
      Peruvian Ministry of Health-recommended interventions. All children will be followed up to
      their 24-month visit and all will be given mebendazole at that time.

      Additional secondary outcomes include length gain, motor and cognitive development and STH
      prevalence and intensity.

      Improving child health is a priority area in global health research and a focus of the
      Millennium Development Goals. Early preschool-age children are at the most critical stage of
      growth and development and have been neglected in deworming programs. It is anticipated that
      the results will inform evidence-based policy on the provision of an integrated health
      package for young children in endemic areas and ultimately contribute to the reduction of
      health inequities in this vulnerable group.
    

Intervention name(s): Mebendazole; Usual care
Intervention type(s): Drug; Other
Intervention description(s): Single-dose 500 mg mebendazole tablet; Routine child health interventions (e.g. age-specific immunizations, supplementations, etc.)
Other intervention name(s): Vermox, Nemasole, Pantelmin; Standard of care, routine health care services
Intervention MeSH terms: Mebendazole; Piperazine; Piperazine citrate; DMP 777
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: preschool-age children; soil-transmitted helminths; growth; development; deworming