NCT03050970

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,802

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

February 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2019

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

2.6 years

First QC Date

January 31, 2017

Last Update Submit

November 17, 2025

Conditions

Head Trauma

Keywords

minor head traumachildage less than 2 yearsClinically-important traumatic brain injury (ciTBI)Computed tomography scanRadiation exposure from CT scans

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Rate of CT scans that would be recommended by the PELICAN rule applied in the study population

    Initial emergency clinical evaluation

  • Rate of CT scans that would be recommended by the PELICAN rule applied in the study population

    24 hours following the initial evaluation

  • Number of patients with any of the six predictive variables of PECARN rule and classification in each risk-level group

    Initial emergency clinical evaluation

  • Number of patients with TBI on CT undergoing neurosurgery

    7 days after head trauma

  • Rate of CT scan use in practice

    7 days after head trauma

  • +2 more secondary outcomes

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants aged less than two years attending at emergency departments

You may qualify if:

  • 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
  • Child with social insurance

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Emergency Department - Necker-Enfants malades Hospital -

Paris, Paris, 75015, France

Location

Related Publications (9)

  • 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.

    PMID: 19758692BACKGROUND

  • 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.

    PMID: 24431418BACKGROUND

  • 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.

    PMID: 22724450BACKGROUND

  • 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.

    PMID: 20142371BACKGROUND

  • 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.

    PMID: 23878053BACKGROUND

  • 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 Gonzalez 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.

    PMID: 22681860BACKGROUND

  • Greenes DS, Schutzman SA. Clinical indicators of intracranial injury in head-injured infants. Pediatrics. 1999 Oct;104(4 Pt 1):861-7. doi: 10.1542/peds.104.4.861.

    PMID: 10506226BACKGROUND

  • 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. doi: 10.1067/s0196-0644(03)00425-6.

    PMID: 14520320BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Officials

  • Gérard CHERON, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

  • Géraldine PATTEAU, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 13, 2017

Study Start

February 11, 2017

Primary Completion

September 17, 2019

Study Completion

September 17, 2019

Last Updated

November 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)