Shaken Baby SyndromeNCT02309216
Whole-Body MRI in Suspected Victims of Abusive Head Trauma
An observational study of Shaken Baby Syndrome, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose: to pilot whole-body MRI scanning in infants who are already getting brain MRI for suspected child abuse Research design: prospective, blinded reading of Whole-Body MRI (WB-MRI) images during the routine care of the hospitalized infant with comparison to routine radiographic skeletal survey images… Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Shaken Baby Syndrome
- What is being tested?
- Whol-Body MRI scan
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jan 2016
- 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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Infant inpatients being evaluated for suspected abusive head trauma who are already getting an MRI of the head and cervical spine.
Who may be able to join
- younger than 12 months
- admitted to the hospital
- getting an MRI for suspected abusive head trauma
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose: to pilot whole-body MRI scanning in infants who are already getting brain MRI for suspected child abuse
Research design: prospective, blinded reading of Whole-Body MRI (WB-MRI) images during the routine care of the hospitalized infant with comparison to routine radiographic skeletal survey images
Read more
Procedures to be used: whole-body MRI images
Risks and potential benefits: no additional risk (the infant will be receiving and MRI of their brain as part of routine care, the additional images will be obtained at the same time without additional sedation); benefits to the infant include the identification of injuries which would have otherwise been missed by routine care importance of knowledge that may reasonably be expected to result: results from this study will potentially influence the use of radiographic skeletal survey and decrease the radiation exposure to infants being evaluated for suspected child abuse.
- Conditions
- Shaken Baby Syndrome
- Being tested
- Whol-Body MRI scan
- Medical subject headings
- Shaken Baby Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whol-Body MRI scanOther
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI findings of skeletal injuries, soft tissue injuries or visceral injuries
Whole Body MRI images will be read by a masked pediatric radiologist and compared with findings obtained by routine imaging and clinical evaluation
Measured: During hospitalization; MRI will typically be obtained on hospitalization day #2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shaken Baby SyndromeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Wootton, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309216
- Sponsor's protocol ID
- HSC-MS-14-0715
- Status last verified
- May 2017
- First submitted
- 1 Dec 2014
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Body MRI in Suspected Victims of Abusive Head Trauma
- ClinicalTrials.gov ID
- NCT02309216
- Acronym / sponsor ID
- HSC-MS-14-0715
- Conditions
- Shaken Baby Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Dec 2014 (estimated)
- 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 purpose: to pilot whole-body MRI scanning in infants who are already getting brain MRI for suspected child abuse
Research design: prospective, blinded reading of Whole-Body MRI (WB-MRI) images during the routine care of the hospitalized infant with comparison to routine radiographic skeletal survey images
Procedures to be used: whole-body MRI images
Risks and potential benefits: no additional risk (the infant will be receiving and MRI of their brain as part of routine care, the additional images will be obtained at the same time without additional sedation); benefits to the infant include the identification of injuries which would have otherwise been missed by routine care importance of knowledge that may reasonably be expected to result: results from this study will potentially influence the use of radiographic skeletal survey and decrease the radiation exposure to infants being evaluated for suspected child abuse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infant inpatients being evaluated for suspected abusive head trauma who are already getting an MRI of the head and cervical spine.
Key inclusion criteria (3 listed)
- younger than 12 months
- admitted to the hospital
- getting an MRI for suspected abusive head trauma
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whol-Body MRI scan | Other | – |
Primary outcome
MRI findings of skeletal injuries, soft tissue injuries or visceral injuries
Time frame: During hospitalization; MRI will typically be obtained on hospitalization day #2
Whole Body MRI images will be read by a masked pediatric radiologist and compared with findings obtained by routine imaging and clinical evaluation
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 10 May 2017.
Related trials for Shaken Baby Syndrome
Not yet recruiting
The Impact of the Nurse-Led "My Baby is Safe" Educational Program
Sudden Infant Death Syndrome, Shaken Baby Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shaken Baby Syndrome, run by The University of Texas Health Science Center, Houston at 1 site 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 3 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
MRI findings of skeletal injuries, soft tissue injuries or visceral injuries (time frame: During hospitalization; MRI will typically be obtained on hospitalization day #2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2017.