Clinical trial NCT03423836: Maternal Oral Therapy to Reduce Obstetric Risk Kids
Official title: Maternal Oral Therapy to Reduce Obstetric Risk Kids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Autism
Premature Infants
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2018-02-06
Enrollment: 331
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 525 infants are planned to be enrolled at the 3 performance sites. The number of infants enrolled at each site will depend on their past Motor recruitment rates, and the observed delivery rate of high risk babies at that site. Infants will be enrolled from both the high risk and low risk group. This rate of enrollment is expected to vary by 10% to 20% across the sites. It is expected that sites will enroll 3-6 infants a month over a 3 year period. The intended sample size is fixed, over sampling among the low risk group will be used to assure the sample size.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: MCHAT Score
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Department of Ostetrics and Gynecology
state: Alabama
city: Chapel Hill
country: United States
facility: Department of Periodontology, UNC School of Dentistry
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carl Bose, MD
role: PRINCIPAL_INVESTIGATOR
References: