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Search / Trial NCT05361122

Prevention of Developmental Delay and Xylitol (PDDaX) Study

Launched by UNIVERSITY OF WASHINGTON · Apr 29, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Xylitol Oral Health Pregnancy Prematurity

ClinConnect Summary

The PDDaX Study is looking at how we can better understand and support the development of children who were born prematurely or with neurodevelopmental disorders. The researchers want to see if a simple and affordable tool called the Malawi Developmental Assessment Tool (MDAT) can effectively assess the development of children aged 4 to 8 years old compared to a more complex and expensive tool known as the Kaufman Assessment Battery for Children-II (KABC-II). They will be testing 1,000 children, with half having been born prematurely and the other half born at full term. Additionally, the study will explore whether exposure to xylitol—found in some chewing gums—during pregnancy has any positive effects on the children's development.

To be eligible for this study, children must have been born during a previous trial and be between 4 and 8 years old. Parents or guardians need to give their consent for participation, and the children must be willing to undergo three developmental tests at a specific location. The study aims to include all genders and will ensure that families understand what participation involves. This research is important as it could lead to better ways to support the healthy development of children who were born prematurely.

Gender

ALL

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

About University Of Washington

The University of Washington (UW) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust network of interdisciplinary teams, UW fosters collaboration among top-tier researchers, clinicians, and healthcare professionals, aiming to translate scientific discoveries into impactful treatments and interventions. The university is dedicated to ethical research practices and participant safety, ensuring rigorous adherence to regulatory standards in all clinical trials. Through its state-of-the-art facilities and extensive expertise, UW strives to address pressing health challenges and improve patient outcomes on a local and global scale.

Locations

Lilongwe, , Malawi

Patients applied

0 patients applied

Trial Officials

Greg Valentine, MD

Principal Investigator

University of Washington

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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