Prevention of Developmental Delay and Xylitol (PDDaX) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorUniversity of Washington
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Parent or legal guardian cognitively unable to provide consent
Child unwilling to provide assent to participate in the study
Trial design
Design model
Parallel
Treatments tested in this trial
Maternal Use of Xylitol Chewing Gum During Pregnancy
Dietary supplementThere 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).
No Maternal Xylitol Chewing Gum Use During Pregnancy
Dietary supplementThere 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
Treatment groups
1,000 Participants
are divided into 4 treatment groupsGroup A: Xylitol-exposed formerly term childrenExperimental treatment 1 intervention
Group B: Non xylitol-exposed formerly term childrenActive comparator 1 intervention
Group C: Xylitol-exposed formerly preterm childrenExperimental treatment 1 intervention
Group D: Non xylitol-exposed formerly preterm childrenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Validation of the MDAT in Former Preterm Children
compared to the KABC-II
Time frame
1 month (1-2 clinic visits)2
Validation of the MDAT in Former Term Children
compared to the KABC-II
Time frame
1 month (1-2 clinic visits)3
KABC-II mental processing index
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
Time frame
1 month (1-2 clinic visits)4
EF Touch composite score
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
Time frame
1 month (1-2 clinic visits)Secondary outcomes
1
Incidence of cognitive delay per specific KABC-II subdomain
sequential processing (working memory), simultaneous processing (visual processing), planning ability (fluid reasoning), and learning ability (long-term memory and retrieval)
Time frame
1 month (1-2 clinic visits)2
Incidence of executive function delay per specific EF Touch subdomains
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")
Time frame
1 month (1-2 clinic visits)3
Incidence of social-emotional delay per specific SDQ subdomains
Emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior
Time frame
1 month (1-2 clinic visits)4
Incidence of neurodevelopmental delay as per MDAT subdomains
Gross motor, fine motor, social, and language
Time frame
1 month (1-2 clinic visits)Sponsors and contacts
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Source ClinicalTrials.gov