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

NCT02731781 | Unknown

• 1 other identifier: 0130-15-LND
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

TO FIND THE CORRELATION BETWEEN TINS SCORE OUTCOME

Keywords

OUTCOME; PROGNOSIS; PEDIATRIC HEAd injury; CT SCAN

Outcome Measures

Primary Outcomes (1)

• Neurological outcome at Discharge or within 1 month

  clinical follow up and examination at discharge and clinics within 1 month after trauma

  up to 1 month

Secondary Outcomes (1)

• Neurological outcome at 1 year after head injury in the Infant

  up to 1 year after trauma

Interventions

NONE . OBSERVATIONAL OTHER

OBSEVATION AND FOLLOW UP

Eligibility Criteria

• Age: 24 Hours - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants younger that 24 months who sustained head injury (Head Trauma)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Laniado Hospital: lead

Study Sites (1)

Sharon Nechama, Laniado Hospital

Netanya, Israel, Israel

Location

Related Publications (7)

• Hahn YS, Chyung C, Barthel MJ, Bailes J, Flannery AM, McLone DG. Head injuries in children under 36 months of age. Demography and outcome. Childs Nerv Syst. 1988 Feb;4(1):34-40. doi: 10.1007/BF00274081.

  PMID: 3401866 BACKGROUND

• Raimondi AJ, Hirschauer J. Head injury in the infant and toddler. Coma scoring and outcome scale. Childs Brain. 1984;11(1):12-35. doi: 10.1159/000120157.

  PMID: 6705608 BACKGROUND

• Morray JP, Tyler DC, Jones TK, Stuntz JT, Lemire RJ. Coma scale for use in brain-injured children. Crit Care Med. 1984 Dec;12(12):1018-20. doi: 10.1097/00003246-198412000-00002.

  PMID: 6509997 BACKGROUND

• Reilly PL, Simpson DA, Sprod R, Thomas L. Assessing the conscious level in infants and young children: a paediatric version of the Glasgow Coma Scale. Childs Nerv Syst. 1988 Feb;4(1):30-3. doi: 10.1007/BF00274080.

  PMID: 3135935 BACKGROUND

• Seshia SS, Seshia MM, Sachdeva RK. Coma in childhood. Dev Med Child Neurol. 1977 Oct;19(5):614-28. doi: 10.1111/j.1469-8749.1977.tb07995.x. No abstract available.

  PMID: 913902 BACKGROUND

• Beni-Adani L, Flores I, Spektor S, Umansky F, Constantini S. Epidural hematoma in infants: a different entity? J Trauma. 1999 Feb;46(2):306-11. doi: 10.1097/00005373-199902000-00018.

  PMID: 10029038 BACKGROUND

• Yi W, Liu R, Chen J, Tao S, Humphrey O, Bergenheim AT. Trauma infant neurologic score predicts the outcome of traumatic brain injury in infants. Pediatr Neurosurg. 2010;46(4):259-66. doi: 10.1159/000321800. Epub 2010 Dec 16.

  PMID: 21160234 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: April 8, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2020
• Last Updated: April 8, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)