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Prevention of Developmental Delay and Xylitol (PDDaX) Study

RecruitingNAAges 4 Years - 8 YearsAllUniversity of Washington
NCT05361122 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goals of this study are to: evaluate and validate the low-cost, transportable, easily-administered Malawi Developmental Assessment Tool (MDAT) for neurodevelopmental assessment of children aged 4-8 years old in Malawi, as compared to the gold-standard yet more cumbersome and costly Kaufman Assessment Battery for Children-II (KABC-II) among (1) n=500 formerly preterm children and (2) n=500 formerly term children. Additionally, we will evaluate the effects of gestational xylitol exposure compared to a lack of gestational xylitol exposure on neurodevelopmental outcomes of children aged 4-8 years old in Malawi through the following four neurodevelopmental tests: (3) KABC-II (cognitive outcomes), (4) EF Touch (executive functions), (5) Strengths and Difficulties Questionnaire (social-emotional outcomes), and (6) MDAT (motor and cognitive outcomes). The researchers will leverage subjects

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📋 Eligibility rules (as published)
Inclusion Criteria: * Child born during the PPaX trial * Enrollment age between 4-8 years old * Parental or legal guardian consent obtained * Willing to undergo 3 neurodevelopmental tests * Willing to travel to BCMF for neurodevelopmental assessment * Assent by the pediatric subject for participation in the study Exclusion Criteria: * Parent or legal guardian cognitively unable to provide consent * Child unwilling to provide assent to participate in the study
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What it tests

  • Maternal Use of Xylitol Chewing Gum During Pregnancy
  • No Maternal Xylitol Chewing Gum Use During Pregnancy
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Where

1 site
Baylor College of Medicine Children's Foundation-Malawi
Lilongwe, Malawi
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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