Status:
COMPLETED
Maternal Oral Therapy to Reduce Obstetric Risk Kids
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Periodontitis
Autism
Eligibility:
All Genders
1+ years
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- Only a random sample of the low risk group will be recruited.
Key Trial Info
Start Date :
April 30 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 11 2013
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT03423836
Start Date
April 30 2007
End Date
January 11 2013
Last Update
February 14 2018
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham Department of Ostetrics and Gynecology
Birmingham, Alabama, United States, 35249
2
Department of Periodontology, UNC School of Dentistry
Chapel Hill, North Carolina, United States, 27514
3
Duke University
Durham, North Carolina, United States, 27705
4
University of Texas Health Science Center
San Antonio, Texas, United States, 78229