Evaluating the effects of xylitol during pregnancy on child development
Prevention of Developmental Delay and Xylitol (PDDaX) Study
NA · University of Washington · NCT05361122
This study is testing if taking xylitol during pregnancy helps with the brain development of children aged 4 to 8 years, comparing two different ways to measure their progress.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 4 Years to 8 Years |
| Sex | All |
| Sponsor | University of Washington (other) |
| Locations | 1 site (Lilongwe) |
| Trial ID | NCT05361122 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-8 years who were born during the previous trial and whose parents can provide consent.
Not a fit: Children whose parents are unable to provide consent or who are unwilling to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the benefits of xylitol during pregnancy for improving neurodevelopmental outcomes in children.
How similar studies have performed: While the approach of using xylitol during pregnancy is innovative, similar studies have not been widely conducted, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lilongwe
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prematurity, Neurodevelopmental Disorders, Xylitol, Oral Health, Pregnancy