Xylitol vs Control: Number of Infants With Adverse Neonatal Composite Morbidity and Mortality

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

Measures 6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

Measure	Value	95% interval, lower	95% interval, upper	Method	Source
Risk in group 1	0.0306	0.0259	0.0361	wilson	ClinicalTrials.gov
Risk in group 2	0.0447	0.0395	0.0506	wilson	ClinicalTrials.gov
Risk difference, group 1 minus group 2	-0.0141	-0.0217	-0.00652	newcombe hybrid score	ClinicalTrials.gov
Risk ratio, group 1 over group 2	0.684	0.555	0.842	log	ClinicalTrials.gov
Odds ratio, group 1 over group 2	0.674	0.543	0.836	log	ClinicalTrials.gov
Number needed to treat, for one fewer participant with the outcome on Xylitol than on Control	70.7	46.1	153	from the risk difference interval	ClinicalTrials.gov

Groups 2

Group 2 names the comparator: control.

Group	Title	Description	With the outcome	Analysed	ClinicalTrials.gov code	Source
Group 1	Xylitol	Intervention group (twice daily xylitol gum use during pregnancy)	133	4,349	OG001	ClinicalTrials.gov
Group 2	Control	Control group (no xylitol gum exposure)	238	5,321	OG000	ClinicalTrials.gov

Outcome 5

Field	Value	Source
Type	SECONDARY	ClinicalTrials.gov
Title	Number of Infants With Adverse Neonatal Composite Morbidity and Mortality	ClinicalTrials.gov
Description	Additive or singular composite neonatal morbidity up to 28 days of age. Composite neonatal morbidity and mortality outcomes are defined as: neonatal death, miscarriage \<28 weeks, stillbirth (fresh or macerated), neonatal sepsis, neonatal respiratory distress, neonatal seizures, feeding problems, fever, hypothermia, Apgar score \<7 at 5 minutes after birth, referral to other hospital or neonatal intensive care unit (NICU)	ClinicalTrials.gov
Time frame	Date of delivery to 28 days postnatal	ClinicalTrials.gov
Population		ClinicalTrials.gov

Trial 8

Field	Value	Source
Title	Saving Lives at Birth: Primary Prevention of Periodontal Disease in Relation to Preterm Birth in Malawi	ClinicalTrials.gov
NCT number	NCT02333227	ClinicalTrials.gov
Phases	NA	ClinicalTrials.gov
Conditions	Preterm Birth, Periodontal Disease, Caries, Dental	ClinicalTrials.gov
Interventions	Xylitol gum	ClinicalTrials.gov
Lead sponsor	Baylor College of Medicine	ClinicalTrials.gov
Results first posted	2024-01-08	ClinicalTrials.gov
Results on ClinicalTrials.gov	https://clinicaltrials.gov/study/NCT02333227?tab=results	ClinicalTrials.gov

Source 4

Field	Value	Source
Release	trial-comparisons-2026-03-23-0.1.0	ClinicalTrials.gov
Release manifest SHA-256	f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57	ClinicalTrials.gov
AACT copy	2026-03-23	ClinicalTrials.gov
Tables read	outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet	ClinicalTrials.gov

The same record as JSON

Release trial-comparisons-2026-03-23-0.1.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.