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Maternal Oral Therapy to Reduce Obstetric Risk Kids (MOTORKids)

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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

January 31, 2018
February 6, 2018
February 14, 2018
April 30, 2007
May 31, 2010   (Final data collection date for primary outcome measure)
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.
MCHAT Score [ Time Frame: 24 months ]
MCHAT composite risk score
Complete list of historical versions of study NCT03423836 on ClinicalTrials.gov Archive Site
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Maternal Oral Therapy to Reduce Obstetric Risk Kids
Maternal Oral Therapy to Reduce Obstetric Risk Kids
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
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.
  • Periodontitis
  • Autism
  • Premature Infants
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
331
Same as current
January 11, 2013
May 31, 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
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Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03423836
07-0727
3U01DE014577-04S1 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Carl Bose, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
January 2018