Infant Minor Head Trauma Clinical Decision Rule

Head Trauma Clinical Trial

— PELICAN  

Official title:

Performance of a Minor Head Trauma Clinical Decision Rule Dedicated to Children Younger Than Two Years: A National Prospective Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050970
• Other study ID #: 2016-A00629-42
• Secondary ID: NI 15019 - AOM 1
• Status: Completed
• Start date: February 11, 2017
• Est. completion date: September 17, 2019

Study information

• Verified date: November 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to validate a clinical decision rule for the management of minor head trauma in infants aged less than two years, constructed with the intention of minimizing the rate of computed tomography scans ordering.

Description:

Apparently minor head trauma (MHT), defined by a Glasgow coma scale score (GCS) of 14-15, is the most frequently assessed group among the population of children attending Emergency Department (ED) for head trauma. Less than 1% of children with MHT have a clinically important traumatic brain injury (ciTBI) that is requiring immediate and specific care, especially neurosurgery. Those ciTBI should be identified rapidly. Assessment of children < 2 years is particularly difficult. This may promote excessive computed tomography (CT) scans ordering in this age group, while the youngest are the most sensitive to the risk of secondary malignity induced by ionizing radiation from CT scan. In USA, 31% of children < 2 years with MHT undergo CT scan. Data for CT scan use in France are unavailable and subjected to practice variations. The predictive values of TBI clinical variables such as vomiting, immediate loss of consciousness, impact seizure, severe injury mechanism, scalp hematoma or skull fracture, are controversial. A short clinical observation of children with such signs or post-traumatic symptoms before making the decision regarding CT scan ordering seems to be beneficial, allowing selective CT scan use for children whose symptoms fail to resolve. To improve patient care, clinical decision rules attempting to risk-stratify the need for a scan have emerged in the literature. Age-based PECARN rule derived and validated in the larger cohort of 10 718 children < 2 years is the reference in the management of minor head trauma. The PECARN rule identifies ciTBIs with an optimal sensitivity but with a high rate of normal scans or identifying a non-significant lesion (expected CT scans rate: 23%; ciTBI: 0,85%). This North American rule is recommended by the Emergency Medicine French Society for the management of minor head injury. This study aims to evaluate the performance of the PELICAN rule, a decision rule for the management of apparently minor head trauma in children < 2 years that proposes targeted indications for CT scan use and defines precise indications for clinical observation. The PELICAN rule was built after a literature review of the predictive values of TBI clinical variables with the intention of minimizing the CT scans rate without missing any ciTBI. The primary objective is to assess the performance of the PELICAN clinical prediction rule for identifying clinical-important traumatic brain injuries after apparently minor head trauma (GCS 14-15) in infants less than 2 years. The performance of the PECARN TBI prediction rule when applied to a large national French population will also be assisted and compared to that of PELICAN rule in terms of security, efficacy and expected impact on CT ordering.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8802
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• Child aged less than 2 years presenting to pediatric emergencies for evaluation within 24 hours of an apparently minor blunt head trauma, defined by a pediatric Glasgow coma scale score of 14 or 15 at initial clinical assessment
• Non opposition from parents to their child inclusion and collect of these data
• Child with social insurance

Exclusion Criteria:

• Trivial head injury
• Neurosurgical history
• Pre-existing neurological disorder
• Bleeding disorder
• Suspected child abuse
• Open fracture
• Penetrating skull injury
• Polytrauma and substantial non cranial serious injury
• Isolated facial trauma
• Imaging performed before ED visit
• Prior inclusion of the child in the study

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
France	Pediatric Emergency Department - Necker-Enfants malades Hospital -	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Francophone Pediatric Resuscitation and Emergency Group (GFRUP)

Country where clinical trial is conducted

France, 

References & Publications (9)

Bressan S, Romanato S, Mion T, Zanconato S, Da Dalt L. Implementation of adapted PECARN decision rule for children with minor head injury in the pediatric emergency department. Acad Emerg Med. 2012 Jul;19(7):801-7. doi: 10.1111/j.1553-2712.2012.01384.x. Epub 2012 Jun 22. — View Citation

Greenes DS, Schutzman SA. Clinical indicators of intracranial injury in head-injured infants. Pediatrics. 1999 Oct;104(4 Pt 1):861-7. — View Citation

Jehlé E, Honnart D, Grasleguen C, et al. Comité de pilotage. Minor head injury (Glasgow Coma Score 13 to 15): triage, assessment, investigation and early management of minor head injury in infants, children and adults. Ann Fr Med Urg 2012;2:199-214

Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14. Erratum in: Lancet. 2014 Jan 25;383(9914):308. — View Citation

Osmond MH, Klassen TP, Wells GA, Correll R, Jarvis A, Joubert G, Bailey B, Chauvin-Kimoff L, Pusic M, McConnell D, Nijssen-Jordan C, Silver N, Taylor B, Stiell IG; Pediatric Emergency Research Canada (PERC) Head Injury Study Group. CATCH: a clinical decision rule for the use of computed tomography in children with minor head injury. CMAJ. 2010 Mar 9;182(4):341-8. doi: 10.1503/cmaj.091421. Epub 2010 Feb 8. — View Citation

Palchak MJ, Holmes JF, Vance CW, Gelber RE, Schauer BA, Harrison MJ, Willis-Shore J, Wootton-Gorges SL, Derlet RW, Kuppermann N. A decision rule for identifying children at low risk for brain injuries after blunt head trauma. Ann Emerg Med. 2003 Oct;42(4):492-506. — View Citation

Pearce MS, Salotti JA, Little MP, McHugh K, Lee C, Kim KP, Howe NL, Ronckers CM, Rajaraman P, Sir Craft AW, Parker L, Berrington de González A. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet. 2012 Aug 4;380(9840):499-505. doi: 10.1016/S0140-6736(12)60815-0. Epub 2012 Jun 7. — View Citation

Rogers AJ, Maher CO, Schunk JE, Quayle K, Jacobs E, Lichenstein R, Powell E, Miskin M, Dayan P, Holmes JF, Kuppermann N; Pediatric Emergency Care Applied Research Network. Incidental findings in children with blunt head trauma evaluated with cranial CT scans. Pediatrics. 2013 Aug;132(2):e356-63. doi: 10.1542/peds.2013-0299. Epub 2013 Jul 22. — View Citation

Schonfeld D, Bressan S, Da Dalt L, Henien MN, Winnett JA, Nigrovic LE. Pediatric Emergency Care Applied Research Network head injury clinical prediction rules are reliable in practice. Arch Dis Child. 2014 May;99(5):427-31. doi: 10.1136/archdischild-2013-305004. Epub 2014 Jan 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of a clinically-important traumatic brain injuries (ciTBI)	Clinically-important traumatic brain injury defined by: death, intubation > 24h, neurosurgical intervention and/or admission > 2 nights for head injury with traumatic brain injury on CT scan	7 days after head trauma
Secondary	Rate of CT scans that would be recommended by the PELICAN rule applied in the study population	Assessment of the number of children with any of the PELICAN predictive variables recommending CT scan ordering	Initial emergency clinical evaluation
Secondary	Rate of CT scans that would be recommended by the PELICAN rule applied in the study population	Assessment of the number of children with any of the PELICAN predictive variables recommending CT scan ordering	24 hours following the initial evaluation
Secondary	Number of patients with any of the six predictive variables of PECARN rule and classification in each risk-level group	Performance of the age-based PECARN TBI prediction rule for identifying ciTBI	Initial emergency clinical evaluation
Secondary	Number of patients with TBI on CT undergoing neurosurgery	TBI outcomes of children < 2 years	7 days after head trauma
Secondary	Rate of CT scan use in practice	to analyse the different management care strategies applied to a large national French observational study population	7 days after head trauma
Secondary	Number of patients with a non-clinically significant TBI identified on CT scan who would have been missed by the PELICAN rule	Presence of a TBI on CT scan that doesn't result in death, intubation < 24h, neurosurgery and/or admission over 2 nights, in a patient who had no PELICAN predictors recommending CT scan.; Presence in these patients of post-traumatic signs or symptoms requiring admission or any specific therapy	7 days after head trauma
Secondary	Rate of Admission for short ED clinical observation expected by the application of PELICAN rule	Presence of a PELICAN variable recommending short clinical observation	24 hours after head trauma