Prevention of Developmental Delay and Xylitol (PDDaX) Study

Not Applicable

Recruiting

• Conditions: Neurodevelopmental Disorders; Prematurity
• Interventions: Dietary Supplement: Maternal Use of Xylitol Chewing Gum During Pregnancy; Dietary Supplement: No Maternal Xylitol Chewing Gum Use During Pregnancy

• Registration Number: NCT05361122
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-29
• Study First Posted: 2022-05-04
• Status Verified: 2023-04
• Study Start: 2023-04-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-18
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

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Exclusion Criteria

• Parent or legal guardian cognitively unable to provide consent
• Child unwilling to provide assent to participate in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xylitol-exposed formerly term children	Maternal Use of Xylitol Chewing Gum During Pregnancy	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)
Non xylitol-exposed formerly term children	No Maternal Xylitol Chewing Gum Use During Pregnancy	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)
Non xylitol-exposed formerly preterm children	No Maternal Xylitol Chewing Gum Use During Pregnancy	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)
Xylitol-exposed formerly preterm children	Maternal Use of Xylitol Chewing Gum During Pregnancy	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)

Primary Outcome Measures

Name	Time	Method
MDAT composite neurodevelopmental outcome	1 month (1-2 clinic visits)	In n=500 former term and n=500 former preterm children aged 4-8 years old with half of each being gestationally xylitol exposed vs not exposed
EF Touch composite score	1 month (1-2 clinic visits)	In n=500 former term and n=500 former preterm children aged 4-8 years old with half of each being gestationally xylitol exposed vs not exposed
SDQ composite	1 month (1-2 clinic visits)	In n=500 former term and n=500 former preterm children aged 4-8 years old with half of each being gestationally xylitol exposed vs not exposed
Validation of the MDAT in Former Preterm Children	1 month (1-2 clinic visits)	compared to the KABC-II
Validation of the MDAT in Former Term Children	1 month (1-2 clinic visits)	compared to the KABC-II
KABC-II mental processing index	1 month (1-2 clinic visits)	In n=500 former term and n=500 former preterm children aged 4-8 years old with half of each being gestationally xylitol exposed vs not exposed

Secondary Outcome Measures

Name	Time	Method
Incidence of neurodevelopmental delay as per MDAT subdomains	1 month (1-2 clinic visits)	Gross motor, fine motor, social, and language
Incidence of cognitive delay per specific KABC-II subdomain	1 month (1-2 clinic visits)	sequential processing (working memory), simultaneous processing (visual processing), planning ability (fluid reasoning), and learning ability (long-term memory and retrieval)
Incidence of executive function delay per specific EF Touch subdomains	1 month (1-2 clinic visits)	processing speed ("Bubbles"), visual spatial working memory ability ("Farmer"), working memory ("Pick the Picture" and "Houses"), inhibitory motor control ("Pig", "Silly Sounds Game", and "Arrows"), and Flexible thinking ("Something's the Same")
Incidence of social-emotional delay per specific SDQ subdomains	1 month (1-2 clinic visits)	Emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior

Trial Locations

Locations (1)

Baylor College of Medicine Children's Foundation-Malawi; 🇲🇼 Lilongwe, Malawi