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    • CT-99021 cost This is the first randomized controlled trial

    2018-10-24

    This is the first randomized controlled trial to examine the effect of deworming on cognitive, language and fine motor skills in early preschool-age children using a rigorous developmental assessment instrument. Overall, this trial was unable to demonstrate a benefit of any of the deworming schedules on development with a follow-up of 12 months (i.e. between one and two years of age). Only one other trial has examined the potential benefit of deworming on development in early childhood, measured by cognitive and gross motor skills, but it was limited by a small sample size, the use of parental report for assessment of developmental outcomes, and a lack of a rigorous developmental test (Stoltzfus et al., 2001). All other trials looking at the link between deworming and developmental outcomes have been conducted in school-age populations. Although results in older age groups are not necessarily comparable to early preschool-age children in the critical window of development, our results are consistent with the majority of evidence which has not yet demonstrated a clear association between deworming and improvements in cognition (Taylor-Robinson et al., 2015). If there is a true benefit to deworming, it may have been difficult to detect this after only one-year of follow-up. The low prevalence of STH infection at baseline may also explain our findings. In addition, one of the mechanisms through which STH infection is thought to impact cognition is by causing malnutrition (Kvalsvig & Albonico, 2013). As we were unable to demonstrate a benefit of deworming on the primary outcome of growth, and prevalences of malnutrition, particularly stunting, increased dramatically over one year of follow-up, this may explain why there was no effect of deworming on development outcomes (Joseph et al., 2015). We were able to demonstrate improved developmental outcomes at the 24-month visit in children with greater height and weight measures at baseline, indicating the importance of targeting the high prevalence of malnutrition in this population. Not surprisingly, maternal education was found to be associated with development scores; however, SES was not. This CT-99021 cost was specifically chosen to be homogeneous in terms of endemicity for STH, high prevalence of malnutrition, and lower SES; therefore, there is likely low variability in SES to detect differences in risk. The association of lower development scores with vitamin A supplementation is also somewhat surprising, but likely due to the fact that vitamin A is distributed strategically in the study area (i.e. to high risk individuals and by certain health centers) according to Ministry of Health guidelines (MINSA, 2011). Overall, the deworming interventions were not sufficient to improve development scores over one year, or to prevent the increasing developmental deficits in cognition and language skills. Due to the multifactorial nature of development, future research should evaluate the effect of integrated interventions, including micronutrient supplementation and child stimulation, to combat malnutrition and developmental deficits in vulnerable early childhood populations (Grantham-McGregor et al., 2014). Participants of the trial are currently being followed-up in an observational cohort with repeated yearly measurements on cognitive, language and motor functioning. This will allow us to evaluate any effect of the early deworming interventions on development in the longer-term.
    Acknowledgments We acknowledge financial support from the Thrasher Research Fund (USA), the Canadian Institutes of Health Research (MOP-110969; Vanier Canada Graduate Scholarship; Michael Smith Foreign Study Supplement; Planning and Dissemination Grant) and the Fonds de Recherche du Québec – Santé (Canada). We are grateful for the support and collaboration of the local Ministry of Health (Dirección Regional de Salud Loreto), and in particular, the director, Dr. Hugo Rodriguez and all personnel at the participating health centres. We thank our Peruvian-based team, including the research assistants and laboratory personnel who were involved in data collection activities in the field and laboratory, as well as Hugo Razuri and Patrick Belisle for their support in Canada. We acknowledge Drs. Grace Marquis, Antonio Montresor and Brian Ward for their contribution to the original study design, and Dr. Frances Aboud for her input into the Bayley-III adaptation and for her helpful discussions on the manuscript. We are also grateful to Mr. Luis Enrique Caycho Gutierrez for his illustrations for the adapted Bayley-III Picture and Stimulus books. We express gratitude to all participating parents and children for their willingness to participate in this research project.