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| ID | Type | Description | Link |
|---|---|---|---|
| 3U01DE014577-04S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| MCHAT Score | 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. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Carl Bose, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Department of Ostetrics and Gynecology | Birmingham | Alabama | 35249 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36697694 | Derived | Bose C, Valentine GC, Philips K, Boggess K, Moss K, Barros SP, Marchesan J, Wu D, O'Shea TM, Peralta-Carcelen M, Goldstein R, Ramamurthy R, Beck JD. Antepartum periodontitis treatment and risk of offspring screening positive for autism spectrum disorder. J Perinatol. 2023 Apr;43(4):470-476. doi: 10.1038/s41372-023-01610-x. Epub 2023 Jan 25. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D001321 | Autistic Disorder |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D000067877 | Autism Spectrum Disorder |
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| Department of Periodontology, UNC School of Dentistry |
| Chapel Hill |
| North Carolina |
| 27514 |
| United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| University of Texas Health Science Center | San Antonio | Texas | 78229 | United States |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |