Maternal Oral Therapy to Reduce Obstetric Risk Kids

Periodontitis Clinical Trial

— MOTORKids  

Official title:

Maternal Oral Therapy to Reduce Obstetric Risk Kids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423836
• Other study ID #: 07-0727
• Secondary ID: 3U01DE014577-04S
• Status: Completed
• Phase: N/A
• First received: January 31, 2018
• Last updated: February 12, 2018
• Start date: April 30, 2007
• Est. completion date: January 11, 2013

Study information

• Verified date: January 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: January 11, 2013
• Est. primary completion date: May 31, 2010
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Periodontitis
• Premature Infants

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Department of Ostetrics and Gynecology	Birmingham	Alabama
United States	Department of Periodontology, UNC School of Dentistry	Chapel Hill	North Carolina
United States	Duke University	Durham	North Carolina
United States	University of Texas Health Science Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MCHAT Score	MCHAT composite risk score for Autism questionnaire is a 20-item screening tool completed by parents of children aged 16-30 months to evaluate Autism Spectrum Disorder (ASD) risk. Score ranges include 0 to 20 with 2 or less indicating low-risk, 3-7 medium-risk and 8-20 indicating high-risk.	24 months