Prevention of Developmental Delay and Xylitol (PDDaX) Study
Prematurity, Neurodevelopmental Disorders
About this trial
This is an interventional prevention trial for Prematurity focused on measuring Xylitol, Oral Health, Pregnancy, Prematurity
Eligibility Criteria
Inclusion Criteria:
- Child born during the PPaX trial
- Enrollment age between 5-8 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
Sites / Locations
- Baylor College of Medicine Children's Foundation-MalawiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
Xylitol-exposed formerly term children
Non xylitol-exposed formerly term children
Xylitol-exposed formerly preterm children
Non xylitol-exposed formerly preterm 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)
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)
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)
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)