Maternal Oral Therapy to Reduce Obstetric Risk Kids (MOTORKids)

University of North Carolina (UNC)

Status: Completed

Conditions: Periodontitis; Premature Infants; Autism

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03423836

3U01DE014577-04S1 (U.S. NIH Grant/Contract)

07-0727

Details and patient eligibility

About

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.

Full 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.

Enrollment: 331 patients

Sex: All

Ages: 1+ day old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All infants born to mothers enrolled to MOTOR study prior to 35 weeks gestational age,
• All small for gestational age (SGA) infants and all infants born after 37 weeks gestation and who were appropriate for gestational age are eligible for enrollment.
• All infants born < 34 weeks gestation and all SGA infants will be considered a high risk infant and will be recruited for enrollment.
• Appropriate weight for gestational age infants born after 37 weeks will be considered low risk infants and a random sample of these infants will be recruited for enrollment.

Exclusion criteria

• Only a random sample of the low risk group will be recruited.

Trial design

331 participants in 2 patient groups

High Risk Infants

Description:

Motor infants born prior to 35 weeks gestational age, or, infants small (\<10th percentile) for gestational age.

Low Risk Infants

Description:

Motor infants born after the completion of the 37th week of gestation and appropriate for gestational age.