NCT05361122

Prevention of Developmental Delay and Xylitol (PDDaX) Study

Recruiting now NA Last updated 27 March 2025

What this trial tests

NA trial testing Maternal Use of Xylitol Chewing Gum During Pregnancy in Prematurity in 1,000 participants. Currently enrolling.

Timeline

4 April 2023

Primary endpoint
31 August 2027

31 August 2027

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	1,000
Start date	4 April 2023
Primary completion	31 August 2027
Estimated completion	31 August 2027
Sites	1 location across Malawi

Drugs / interventions tested

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

Conditions studied

• Prematurity — all drugs for Prematurity →
• Neurodevelopmental Disorders — all drugs for Neurodevelopmental Disorders →

Sponsor

University of Washington

Who can join

Adults 4 to 8, any sex, with Prematurity or Neurodevelopmental Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Prevention of Developmental Delay and Xylitol (PDDaX) trial: study protocol of a nested cohort follow-up from the PPaX (Prevention of Prematurity and Xylitol) trial examining neurodevelopmental outcomes among offspring at 4-8 years of age in Malawi.
   Valentine GC, Collett B, Wallie S, Mhango J, et al · · 2025 · PMID 41239527 · DOI 10.1186/s13063-025-09204-y