Prevention of Developmental Delay and Xylitol (PDDaX) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Maternal Use of Xylitol Chewing Gum During Pregnancy, No Maternal Xylitol Chewing Gum Use During Pregnancy.
- Who it may be relevant to
- Registry conditions: Prematurity, Neurodevelopmental Disorders. Basic parameters: 4 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malawi
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement 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). - 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
Primary outcome measures
- Validation of the MDAT in Former Preterm Children [Time frame: 1 month (1-2 clinic visits)]
- Validation of the MDAT in Former Term Children [Time frame: 1 month (1-2 clinic visits)]
- KABC-II mental processing index [Time frame: 1 month (1-2 clinic visits)]
- EF Touch composite score [Time frame: 1 month (1-2 clinic visits)]
- SDQ composite [Time frame: 1 month (1-2 clinic visits)]
- MDAT composite neurodevelopmental outcome [Time frame: 1 month (1-2 clinic visits)]
Secondary outcome measures (4)
- Incidence of cognitive delay per specific KABC-II subdomain [Time frame: 1 month (1-2 clinic visits)]
- Incidence of executive function delay per specific EF Touch subdomains [Time frame: 1 month (1-2 clinic visits)]
- Incidence of social-emotional delay per specific SDQ subdomains [Time frame: 1 month (1-2 clinic visits)]
- Incidence of neurodevelopmental delay as per MDAT subdomains [Time frame: 1 month (1-2 clinic visits)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Malawi · 1 center
- Baylor College of Medicine Children's Foundation-Malawi — Lilongwe
Publications
- Valentine GC, Collett B, Wallie S, Mhango J, Engmann C, Sullivan E, Seferovic M, Willoughby M, Shayo B, Walson JL, Milgrom P, Aagaard K, Juul SE. 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. PMID 41239527
Identifiers
NCT: NCT05361122 · STUDY00015305