Prevention of Developmental Delay and Xylitol (PDDaX) Study

University of Washington

Status: Enrolling

Conditions: Prematurity; Neurodevelopmental Disorders

Treatments: Dietary Supplement: No Maternal Xylitol Chewing Gum Use During Pregnancy; Dietary Supplement: Maternal Use of Xylitol Chewing Gum During Pregnancy

Study type: Interventional

Funder types: Other

Identifiers

NCT05361122

STUDY00015305

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 4 patient groups

Xylitol-exposed formerly term children

Experimental group

Description:

n=250 formerly term children born during the PPaX trial who were born to gravidae in the interventional arm (received xylitol chewing gum but had access to a dentist and received prenatal counseling)

Treatment:

Dietary Supplement: Maternal Use of Xylitol Chewing Gum During Pregnancy

Non xylitol-exposed formerly term children

Active Comparator group

Description:

n=250 formerly term children born during the PPaX trial who were born to gravidae in the active comparator arm (no xylitol chewing gum but had access to a dentist and received prenatal counseling)

Treatment:

Dietary Supplement: No Maternal Xylitol Chewing Gum Use During Pregnancy

Xylitol-exposed formerly preterm children

Experimental group

Description:

n=250 formerly preterm children born during the PPaX trial who were born to gravidae in the interventional arm (received xylitol chewing gum but had access to a dentist and received prenatal counseling)

Treatment:

Dietary Supplement: Maternal Use of Xylitol Chewing Gum During Pregnancy

Non xylitol-exposed formerly preterm children

Active Comparator group

Description:

n=250 formerly preterm children born during the PPaX trial who were born to gravidae in the active comparator arm (no xylitol chewing gum but had access to a dentist and received prenatal counseling)

Treatment:

Dietary Supplement: No Maternal Xylitol Chewing Gum Use During Pregnancy