Malnutrition Clinical Trial
Official title:
Improving Early Childhood Growth and Development in Resource-poor LMICs by Incorporating Deworming in Integrated Child Health Care
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.
Status | Completed |
Enrollment | 1760 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Months to 24 Months |
Eligibility |
Inclusion Criteria: - children attending any one of the participating study health centres for their routine 12-month growth and development visit - children living in or near the study area Exclusion Criteria: - children who are attending the clinic for suspected STH infection - children who have received deworming treatment in the six months prior to randomization - parents planning to move outside of the study area within the next 12 months - children under 12 months of age or 14 months of age or older - children with serious congenital or chronic medical conditions and who would be considered by the attending staff not to benefit from deworming |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Peru | Asociacion Civil Selva Amazonica | Iquitos | Loreto |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Center | Asociacion Civil Selva Amazonica, Canadian Institutes of Health Research (CIHR), McGill University, Thrasher Research Fund, World Health Organization |
Peru,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean (± standard deviation) weight gain (kg) | Weight will be measured at baseline (12 months of age), and follow-up (18 and 24 months of age) to assess the effect of the deworming intervention on growth (in terms of weight) | from 12 to 24 months of age | No |
Secondary | Mean (± standard deviation) height gain (cm) | Height will be measured at baseline (12 months of age) and at follow-up (18 and 24 months of age) to evaluate the effect of the deworming intervention on growth (in terms of height) | from 12 to 24 months of age | No |
Secondary | Mean (± standard deviation) of the cognitive test score | Cognitive development will be assessed using the Bayley Scale of Infant Development. This scale provides a raw score and standardized score based on age-specific abilities. This will be measured at both baseline (12 months of age) and follow-up (at 24 months of age) to evaluate the effects of the deworming intervention on cognitive development. | from 12 to 24 months of age | No |
Secondary | Soil-transmitted helminth infection (Ascaris, Trichuris or hookworm) - prevalence (%) and intensity (mean eggs per gram) | Soil-transmitted helminth (STH) infection will be assessed from stool samples provided by participants. The Kato-Katz technique will be used to provide both an estimate of prevalence of each STH (e.g. % positive for each Ascaris, Trichuris, and/or hookworm) as well as an estimate of intensity of each STH (measured as mean eggs per gram of stool). This will be measured at baseline (12 months of age) and follow-up (18 and 24 months of age) to evaluate the effect of the deworming intervention on parasite prevalence and intensity. | from 12 to 24 months of age | No |
Secondary | Mean (± standard deviation) of the motor test score | Fine motor development will be assessed using the Bayley Scale of Infant Development. This scale provides a raw score and standardized score based on age-specific abilities. This will be measured at both baseline (12 months of age) and follow-up (at 24 months of age) to evaluate the effects of the deworming intervention on motor development. | from 12 to 24 months of age | No |
Secondary | Mean (± standard deviation) of the language test score | Receptive and expressive language development will be assessed using the Bayley Scale of Infant Development. This scale provides a raw score and standardized score based on age-specific abilities. This will be measured at both baseline (12 months of age) and follow-up (at 24 months of age) to evaluate the effects of the deworming intervention on language development. | from 12 to 24 months of age | No |
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