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Maternal Oral Therapy to Reduce Obstetric Risk Kids (MOTORKids)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03423836
Recruitment Status : Completed
First Posted : February 6, 2018
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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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.

Condition or disease
Periodontitis Autism Premature Infants

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 Design
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Study Type : Observational
Actual Enrollment : 331 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal Oral Therapy to Reduce Obstetric Risk Kids
Actual Study Start Date : April 30, 2007
Actual Primary Completion Date : May 31, 2010
Actual Study Completion Date : January 11, 2013
Groups and Cohorts
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Group/Cohort
High Risk Infants
Motor infants born prior to 35 weeks gestational age, or, infants small (<10th percentile) for gestational age.
Low Risk Infants
Motor infants born after the completion of the 37th week of gestation and appropriate for gestational age.


Outcome Measures
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Primary Outcome Measures :
  1. MCHAT Score [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423836


Locations
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United States, Alabama
University of Alabama at Birmingham Department of Ostetrics and Gynecology
Birmingham, Alabama, United States, 35249
United States, North Carolina
Department of Periodontology, UNC School of Dentistry
Chapel Hill, North Carolina, United States, 27514
Duke University
Durham, North Carolina, United States, 27705
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
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Principal Investigator: Carl Bose, MD University of North Carolina, Chapel Hill
More Information
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03423836    
Other Study ID Numbers: 07-0727
3U01DE014577-04S1 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases