NCT05361122 Prevention of Developmental Delay and Xylitol (PDDaX) Study
| NCT ID | NCT05361122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Prematurity |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-04-04 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2023-04-04 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 who completed the parent Prevention of Prematurity and Xylitol Trial, which enrolled 10069 pregnant individuals in Malawi and demonstrated a significant 24% reduction in incidence of preterm birth and low birthweight offspring in gravidae who chewed xylitol-containing chewing gum compared to those who did not. By ensuring that these offspring did not have higher rates of neurodevelopmental impairment, the study will promote promising multi-center international and domestic trial evaluating the impact of xylitol-containing chewing gum use and optimal dosage during pregnancy.
Eligibility 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
Contact & Investigator
Greg Valentine, MD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05361122 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 8 Years, studying Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05361122 currently recruiting?
Yes, NCT05361122 is actively recruiting participants. Contact the research team at gcvalent@uw.edu for enrollment information.
Where is the NCT05361122 trial being conducted?
This trial is being conducted at Lilongwe, Malawi.
Who is sponsoring the NCT05361122 clinical trial?
NCT05361122 is sponsored by University of Washington. The principal investigator is Greg Valentine, MD at University of Washington. The trial plans to enroll 1,000 participants.