PeriodontitisMOTORKidsNCT03423836
Maternal Oral Therapy to Reduce Obstetric Risk Kids
An observational study of Periodontitis and Autism, run by University of North Carolina, Chapel Hill at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Periodontitis, Autism, Premature Infants
- How many people
- 331 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Apr 2007to 11 Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Only a random sample of the low risk group will be recruited.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama at Birmingham Department of Ostetrics and Gynecology
Birmingham, Alabama, 35249
Department of Periodontology, UNC School of Dentistry
Chapel Hill, North Carolina, 27514
Duke University
Durham, North Carolina, 27705
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
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.
Read the 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.
- Conditions
- Periodontitis, Autism, Premature Infants
- Medical subject headings
- Periodontitis, Autistic Disorder, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start30 Apr 2007
- Primary completion31 May 2010
- Study completion11 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Carl Bose, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423836
- Sponsor's protocol ID
- 07-0727
- Other IDs
- 3U01DE014577-04S1
- Acronym
- MOTORKids
- Status last verified
- Jan 2018
- First submitted
- 31 Jan 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36697694
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Oral Therapy to Reduce Obstetric Risk Kids
- ClinicalTrials.gov ID
- NCT03423836
- Acronym / sponsor ID
- MOTORKids / 07-0727
- Conditions
- Periodontitis, Autism, Premature Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 30 Apr 2007 (actual)
- Primary completion
- 31 May 2010 (actual)
- Study completion
- 11 Jan 2013 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Only a random sample of the low risk group will be recruited.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Derived from this study: PubMed 36697694Bose 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Bose, MD principal investigator
University of North Carolina, Chapel Hill
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis and Autism, run by University of North Carolina, Chapel Hill at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCHAT Score (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03423836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.