Prevention of Developmental Delay and Xylitol (PDDaX) Study

NCT ID: NCT05361122

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-04
• Study Completion Date: 2027-08-31

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.

Conditions

Prematurity; Neurodevelopmental Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Xylitol-exposed formerly term children

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)

Group Type: EXPERIMENTAL

Maternal Use of Xylitol Chewing Gum During Pregnancy

Intervention Type: DIETARY_SUPPLEMENT

There are no current interventions within this follow-up study. However, the mothers enrolled in the parent PPaX trial received xylitol-containing chewing gum (1 gram per stick of gum and instructed to chew 1-2 sticks of gum twice daily for a total dose of 2-4 grams/day of xylitol throughout pregnancy starting pre-conception or at \<20 weeks gestation).

Non xylitol-exposed formerly term children

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)

Group Type: ACTIVE_COMPARATOR

No Maternal Xylitol Chewing Gum Use During Pregnancy

Intervention Type: DIETARY_SUPPLEMENT

There are no current interventions within this follow-up study. Children born to mothers who received access to a dentist and prenatal education (oral health, prevention of preterm birth) are in the active comparator group

Xylitol-exposed formerly preterm children

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)

Group Type: EXPERIMENTAL

Maternal Use of Xylitol Chewing Gum During Pregnancy

Intervention Type: DIETARY_SUPPLEMENT

There are no current interventions within this follow-up study. However, the mothers enrolled in the parent PPaX trial received xylitol-containing chewing gum (1 gram per stick of gum and instructed to chew 1-2 sticks of gum twice daily for a total dose of 2-4 grams/day of xylitol throughout pregnancy starting pre-conception or at \<20 weeks gestation).

Non xylitol-exposed formerly preterm children

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)

Group Type: ACTIVE_COMPARATOR

No Maternal Xylitol Chewing Gum Use During Pregnancy

Intervention Type: DIETARY_SUPPLEMENT

There are no current interventions within this follow-up study. Children born to mothers who received access to a dentist and prenatal education (oral health, prevention of preterm birth) are in the active comparator group

Interventions

Maternal Use of Xylitol Chewing Gum During Pregnancy

There are no current interventions within this follow-up study. However, the mothers enrolled in the parent PPaX trial received xylitol-containing chewing gum (1 gram per stick of gum and instructed to chew 1-2 sticks of gum twice daily for a total dose of 2-4 grams/day of xylitol throughout pregnancy starting pre-conception or at \<20 weeks gestation).

Intervention Type: DIETARY_SUPPLEMENT

No Maternal Xylitol Chewing Gum Use During Pregnancy

There are no current interventions within this follow-up study. Children born to mothers who received access to a dentist and prenatal education (oral health, prevention of preterm birth) are in the active comparator group

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Gregory C. Valentine, MD MED FAAP

Assistant Professor: Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Greg Valentine, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Baylor College of Medicine Children's Foundation-Malawi

Lilongwe, , Malawi

Site Status: RECRUITING

Countries

Malawi

Central Contacts

Greg Valentine, MD

Role: CONTACT

gcvalent@uw.edu

(206) 543-3200

Facility Contacts

Phoebe Nyasulu

Role: primary

pnyasulu@baylor-malawi.org

Other Identifiers

STUDY00015305

Identifier Type: -

Identifier Source: org_study_id