ArticleTrials2025
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.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05361122 (Prevention of Developmental Delay and Xylitol), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prevention of Developmental Delay and Xylitol (PDDaX) Study
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundWe recently conducted the cluster-randomized, Prevention of Prematurity and Xylitol (PPaX) trial which demonstrated a significant reduction in the occurrence of delivery of preterm and low birthweight deliveries from mothers who used twice-daily xylitol-containing chewing gum in pregnancy as compared to active control among n = 10,069 enrolled pregnant participants in Lilongwe, Malawi. We seek to determine the neurodevelopmental outcomes, including any benefits or harm, of a nested cohort of n = 1000 children delivered among participants of the PPaX trial.
methodsThe Prevention of Developmental Delay and Xylitol (PDDaX) trial is a prospective, nested cohort study of 1000 randomly selected 4-8-year-old children born to gravid participants who completed the parent PPaX trial. We will assess the neurodevelopmental outcomes of the 1000 children at 4-8 years of age and evaluate any differences in neurodevelopmental outcomes related to xylitol exposure or lack thereof by assessing children's (a) cognition, (b) executive functioning, (c) social-emotional development, (d) gross motor skills, (e) fine motor skills, and (f) language. These neurodevelopmental outcomes will be assessed via the Kaufman Assessment Battery for Children-2nd Edition (KABC-II), the EF Touch, the Strengths and Difficulties Questionnaire, the Malawi Developmental Assessment Tool, the Anchor Items in Measuring Early Childhood Development, and the International Development and Early Learning Assessment. The primary outcome will be the overall cognitive score, as determined by the KABC-II mental processing index. All children will also undergo hearing, vision, and comprehensive oral health examinations. Investigators from the participating sites developed and approved the research question and protocol. Each site obtained its own institutional review board and ethics approval. Patient recruitment started in July 2022 and will continue through 2027. DISCUSSION: Xylitol-containing chewing gum reduces the risk of delivery of a preterm or low birthweight neonate and neonatal demise. It also reduces gingival inflammation in gravidae. The findings from the PDDaX follow-up study will explore whether there are any long-lasting risks or benefits to offspring exposed to xylitol during gestation. If either benefit or lack of benefit (but no harm) occurs to offspring, then xylitol-containing chewing gum has strong potential to change obstetric-related care for individuals in Malawi and similar settings.
trial registrationClinicalTrials.gov NCT05361122. Registered on April 27 2022.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.