Evaluating the effects of xylitol during pregnancy on child development

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness of the Malawi Developmental Assessment Tool (MDAT) for evaluating neurodevelopment in children aged 4-8 years, comparing it to the more complex Kaufman Assessment Battery for Children-II (KABC-II). It will involve 1,000 children, half of whom were born preterm and half term, to determine the impact of maternal xylitol exposure during pregnancy on various neurodevelopmental outcomes. Participants will undergo multiple neurodevelopmental tests to evaluate cognitive, executive function, and social-emotional skills. The study is conducted in Malawi, leveraging a previous trial that enrolled a large number of pregnant women.

Why it matters

Who can join: the full rules

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

Where it's running

• Baylor College of Medicine Children's Foundation-Malawi
  Lilongwe, Malawi Recruiting

Study contacts

• Principal investigator: Greg Valentine, MD — University of Washington
• Study coordinator: Greg Valentine, MD
• Email: gcvalent@uw.edu
• Phone: (206) 543-3200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.