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
|Condition or disease|
|Periodontitis Autism Premature Infants|
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 Type :||Observational|
|Actual Enrollment :||331 participants|
|Official Title:||Maternal Oral Therapy to Reduce Obstetric Risk Kids|
|Actual Study Start Date :||April 30, 2007|
|Primary Completion Date :||May 31, 2010|
|Study Completion Date :||January 11, 2013|
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.
- 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.
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
|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|
|Durham, North Carolina, United States, 27705|
|United States, Texas|
|University of Texas Health Science Center|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Carl Bose, MD||University of North Carolina, Chapel Hill|