University of Washington
Gregory C. Valentine, MD MED FAAP
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.
Prematurity
Neurodevelopmental Disorders
Maternal Use of Xylitol Chewing Gum During Pregnancy
No Maternal Xylitol Chewing Gum Use During Pregnancy
Not Applicable
| Study Type : | Interventional |
| Estimated Enrollment : | 1000 participants |
| Masking : | Single |
| Masking Description : | Psychologists and dentists will be blinded to the treatment status (xylitol or no xylitol use during pregnancy) of the mothers of the pediatric subjects. |
| Primary Purpose : | Prevention |
| Official Title : | Prevention of Developmental Delay and Xylitol (PDDaX) Study |
| Actual Study Start Date : | April 4, 2023 |
| Estimated Primary Completion Date : | August 31, 2027 |
| Estimated Study Completion Date : | August 31, 2027 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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) |
Dietary Supplement: Maternal Use of Xylitol Chewing Gum During Pregnancy |
|
Active Comparator: 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) |
Dietary Supplement: No Maternal Xylitol Chewing Gum Use During Pregnancy |
|
Experimental: 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) |
Dietary Supplement: Maternal Use of Xylitol Chewing Gum During Pregnancy |
|
Active Comparator: 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) |
Dietary Supplement: No Maternal Xylitol Chewing Gum Use During Pregnancy |
| Ages Eligible for Study: | 4 Years to 8 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Baylor College of Medicine Children's Foundation-Malawi
Lilongwe, Malawi,