Clinical trial NCT05361122: Prevention of Developmental Delay and Xylitol (PDDaX) Study
Official title: Prevention of Developmental Delay and Xylitol (PDDaX) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prematurity
Neurodevelopmental Disorders
Keywords: Xylitol
Oral Health
Pregnancy
Prematurity
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will enroll 1000 children aged 4-8 years of age. n=500 will be former term children and additional n=500 will be former preterm children. Half in each group (n=250) will be gestationally xylitol-exposed, and the other half (n=250) will not be xylitol-exposed.
Primary purpose: PREVENTION

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

Primary outcomes:
measure: Validation of the MDAT in Former Preterm Children
timeFrame: 1 month (1-2 clinic visits)
measure: Validation of the MDAT in Former Term Children
timeFrame: 1 month (1-2 clinic visits)
measure: KABC-II mental processing index
timeFrame: 1 month (1-2 clinic visits)
measure: EF Touch composite score
timeFrame: 1 month (1-2 clinic visits)
measure: SDQ composite
timeFrame: 1 month (1-2 clinic visits)
measure: MDAT composite neurodevelopmental outcome
timeFrame: 1 month (1-2 clinic visits)
Secondary outcomes:
measure: Incidence of cognitive delay per specific KABC-II subdomain
timeFrame: 1 month (1-2 clinic visits)
measure: Incidence of executive function delay per specific EF Touch subdomains
timeFrame: 1 month (1-2 clinic visits)
measure: Incidence of social-emotional delay per specific SDQ subdomains
timeFrame: 1 month (1-2 clinic visits)
measure: Incidence of neurodevelopmental delay as per MDAT subdomains
timeFrame: 1 month (1-2 clinic visits)
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Baylor College of Medicine Children's Foundation-Malawi
Study officials:
affiliation: University of Washington
name: Greg Valentine, MD
role: PRINCIPAL_INVESTIGATOR
References: