Prevention of Developmental Delay and Xylitol (PDDaX) Study Evaluating Neurodevelopment in Children Aged 4-8 Years Comparing Xylitol Exposure and Assessment Tools

What this Trial Is About

Researchers are evaluating a low-cost, portable Malawi Developmental Assessment Tool (MDAT) to assess neurodevelopment in children aged 4 to 8 years old in Malawi. This study compares the MDAT with the more complex and expensive Kaufman Assessment Battery for Children-II (KABC-II) among 500 formerly preterm and 500 formerly term children. Additionally, the study examines the impact of gestational exposure to xylitol chewing gum on children's neurodevelopment through tests measuring cognitive, executive function, social-emotional, motor, and cognitive outcomes. The study involves children whose mothers participated in the Prevention of Prematurity and Xylitol (PPaX) trial, where pregnant individuals chewed xylitol-containing gum during pregnancy, reducing preterm birth and low birthweight. This follow-up study has no new interventions; children belong to groups based on whether their mothers used xylitol gum or received prenatal education without xylitol. Neurodevelopment is assessed using four tests: KABC-II, EF Touch, Strengths and Difficulties Questionnaire, and MDAT. Participants will undergo 1 to 2 clinic visits over one month for neurodevelopmental assessments. Children must be willing to complete the tests and travel to the Baylor College of Medicine Foundation (BCMF). Researchers will measure various neurodevelopmental outcomes and validate the MDAT tool. Consent from parents or legal guardians and assent from children are required for participation, with ongoing monitoring to ensure safety and compliance throughout the study period.

Prevention of Developmental Delay and Xylitol (PDDaX) Study