NCT03423836

Maternal Oral Therapy to Reduce Obstetric Risk Kids

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 331 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 1 Day
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Periodontitis
• Autism
• Premature Infants

Timeline

• Start date: 2007-04-30
• Primary completion: 2010-05-31
• Completion: 2013-01-11
• First posted: 2018-02-06
• Last updated: 2018-02-14

Locations

4 sites across 1 country: United States