Prevention of Developmental Delay and Xylitol Study
Gregory Valentine, MD, MEd, FAAP
BACKGROUND: Fetal exposure to maternal infection and inflammation (i.e. maternal periodontitis) is associated with adverse neurodevelopmental outcomes of offspring. We performed a cluster-randomized controlled trial called the Prevention of Prematurity and Xylitol (PPaX) trial, which enrolled 10,069 gravidae in Malawi and demonstrated a significant reduction in maternal periodontal disease with 24% reduction in incidence of preterm birth and 30% reduction in incidence of low birthweight offspring among gravidae who chewed xylitol-containing chewing gum compared to those who did not. GAP: The significant findings and large enrollment that occurred in the PPaX study create an unprecedented opportunity to study the neurodevelopmental outcomes among offspring. Our PDDaX study will elucidate the effects of gestational exposure to xylitol, which is known to prevent and treat periodontitis, on offspring neurodevelopment. HYPOTHESIS: We hypothesize that children with gestational exposure to xylitol will demonstrate improved cognitive, executive functioning, and social-emotional outcomes compared to those in the control group. METHODS: Using a prospective follow-up study design, we will assess (1) cognitive, (2) executive functioning, and (3) social-emotional neurodevelopmental outcomes among randomly selected xylitol-exposed (n=500) and xylitol-unexposed (n=500) children aged 5-8 years old with recruitment of a 1:1 ratio of former preterm and former term (i.e., 250 former preterm and 250 former term in each group). Outcomes will be analyzed separately based upon former preterm or term status. RESULTS: Pending. IMPACT: If neurodevelopmental outcomes are the same or better in xylitol-exposed children compared to control, this innovative, affordable solution of xylitol-containing chewing gum will prevent and treat maternal periodontitis, prevent preterm birth & low birthweight children, with potentially improved neurodevelopment and long-term outcomes of offspring in Malawi.