Periodontitis Clinical Trial
Official title:
Maternal Oral Therapy to Reduce Obstetric Risk Kids
The principal objective was to conduct a 5 year; multi-center, observational follow-up study enrolling infants born to mothers who participated in the MOTOR clinical trial to determine the effects of maternal periodontal therapy during pregnancy on neonatal morbidity and mortality and whether this will result in lower incidence of functional neurological impairment.
A total of 525 infants where planned to be enrolled at the 3 performance sites. The number of
infants enrolled at each site depended on past Motor recruitment rates, and the observed
delivery rate of high risk babies at that site. Infants were enrolled from both the high risk
and low risk groups. The intended sample size was fixed, over sampling among the low risk
group and was used to assure the sample size.
The Data Coordinating Center (DCC) identified and provided each clinical site with
participant listings of all MOTOR high risk births and a randomly ordered sample of low risk
births for enrollment into the study.
Mothers where approached by MOTOR or MOTORkids personnel to ascertain participant interest in
enrolling their infant. Once consent was obtained, infants were followed and tracked until
scheduled for the follow-up exams at age 24 months +/- 2 months adjusted age.
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