Maternal Oral Therapy to Reduce Obstetric Risk Kids

Completed

• Conditions: Autism; Periodontitis; Premature Infants

• Registration Number: NCT03423836
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2007-04-30
• Primary Completion: 2010-05-31
• Study Completion: 2013-01-11
• Status Verified: 2018-01
• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-06
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MCHAT Score	24 months	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.

Trial Locations

Locations (4)

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

University of Texas Health Science Center; 🇺🇸 San Antonio, Texas, United States

Duke University; 🇺🇸 Durham, North Carolina, United States