Trauma Infant Neurological Score (TINS) as a Prognostic Factor and Guideline for CT Scan in Infants 24 Months Old or Less

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02731781
Recruitment Status : Not yet recruiting
First Posted : April 8, 2016
Last Update Posted : April 8, 2016
Information provided by (Responsible Party):
Laniado Hospital

Brief Summary:
Traumatic brain injury (TBI) is the major cause of disability and death among the younger population. In the Pediatric population Head trauma may be responsible for primary and secondary brain damage. Primary brain injury results from a direct mechanical damage at the time of injury, whereas secondary injury is caused by further cellular damage that develops hours or days post injury. Intracranial Injury in Infants (III) may be hard to diagnose in the abcence of neurological deficit or early deterioration. On the other hand, symptoms such as vomiting and restlessness may be present even in the case of minor head injury, and unnesessary scaning (CT) may be performed in many centers just because clinical judgment is problematic in this particular age. Some intracranial injuries may be imminent, such as evolving Epidural hematoma (EDH) in infants, and early diagnosis may be lifesaving and leading to excellent outcome. In adults, GCS has been accepted as the most usuful tool for emergency evaluation of head injured patients. In children, several scores were introduced, including the Children's Coma Score (CCS), however they have been found problematic to use in the very young population, since accurate evaluation of communication in CCS is hard, and there is insufficient relevant parameters uncorporated into the score that may have significant importance in this particular age group. In TINS (Trauma Infant Neurological Score) we characterized the clinical parameters and the mechanism of trauma in a simplified method. As previously published, this score has been used by us and by other groups, in retrospective studies. Still, in the lack of prospective studies using TINS, there are no optimal guidelines to perform computed tomography (CT) in this unique population, and TINS has not prospectively been challenged as a predictor tool for outcome. In this prospective study we will approach these issues.

Condition or disease Intervention/treatment

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Trauma Infant Neurological Score (TINS) as a Prognostic Factor and Guideline for CT Scan in Infants 24 Months Old or Less
Study Start Date : April 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Intervention Details:

Primary Outcome Measures :
  1. Neurological outcome at Discharge or within 1 month [ Time Frame: up to 1 month ]
    clinical follow up and examination at discharge and clinics within 1 month after trauma

Secondary Outcome Measures :
  1. Neurological outcome at 1 year after head injury in the Infant [ Time Frame: up to 1 year after trauma ]
    clinical (and if available radiological follow up) 1 year after trauma

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants younger that 24 months who sustained head injury (Head Trauma)

Inclusion Criteria:

  • Age from birth till 24 months
  • After Head Trauma (any type or severity)
  • Arrival to Emergency room

Exclusion Criteria:

Information from the National Library of Medicine

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 identifier (NCT number): NCT02731781

Sharon Nechama, Laniado Hospital
Netanya, Israel
Sponsors and Collaborators
Laniado Hospital

Responsible Party: Laniado Hospital Identifier: NCT02731781     History of Changes
Other Study ID Numbers: 0130-15-LND
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Laniado Hospital: