Head TraumaPELICANNCT03050970
Infant Minor Head Trauma Clinical Decision Rule
An observational study of Head Trauma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Head Trauma
- How many people
- 8,802 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2017to 17 Sep 2019
- 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 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Infants aged less than two years attending at emergency departments
Who may be able to join
- 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
Who cannot join
- Trivial head injury
- Neurosurgical history
- Pre-existing neurological disorder
- Bleeding disorder
- Suspected child abuse
- Open fracture
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric Emergency Department - Necker-Enfants malades Hospital -
Paris, Paris, 75015
About this study
Official title: Performance of a Minor Head Trauma Clinical Decision Rule Dedicated to Children Younger Than Two Years: A National Prospective Multicenter Study
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.
Read the detailed 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.
- Conditions
- Head Trauma
- Keywords
- minor head trauma, child, age less than 2 years, Clinically-important traumatic brain injury (ciTBI), Computed tomography scan, Radiation exposure from CT scans
- Medical subject headings
- Craniocerebral Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Assessment of the number of children with any of the PELICAN predictive variables recommending CT scan ordering
Measured: Initial emergency clinical evaluation
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
Measured: 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
Performance of the age-based PECARN TBI prediction rule for identifying ciTBI
Measured: Initial emergency clinical evaluation
Number of patients with TBI on CT undergoing neurosurgery
TBI outcomes of children < 2 years
Measured: 7 days after head trauma
Rate of CT scan use in practice
to analyse the different management care strategies applied to a large national French observational study population
Measured: 7 days after head trauma
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
Measured: 7 days after head trauma
Rate of Admission for short ED clinical observation expected by the application of PELICAN rule
Presence of a PELICAN variable recommending short clinical observation
Measured: 24 hours after head trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start11 Feb 2017
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Head TraumaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 8,802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Francophone Pediatric Resuscitation and Emergency Group (GFRUP), URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Gérard CHERON, MD, PhD, Study chair, Assistance Publique - Hôpitaux de ParisGéraldine PATTEAU, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050970
- Sponsor's protocol ID
- 2016-A00629-42
- Other IDs
- NI 15019 - AOM 15311
- Acronym
- PELICAN
- Status last verified
- Oct 2025
- First submitted
- 31 Jan 2017
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19758692Schonfeld 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.
PubMed 24431418Bressan 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.
PubMed 22724450Osmond 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.
PubMed 20142371Rogers 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.
PubMed 23878053Pearce 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.
PubMed 22681860Greenes 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.
PubMed 10506226Palchak 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.
PubMed 14520320Jehlé 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of a Minor Head Trauma Clinical Decision Rule Dedicated to Children Younger Than Two Years: A National Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT03050970
- Acronym / sponsor ID
- PELICAN / 2016-A00629-42
- Conditions
- Head Trauma
- Keywords
- minor head trauma, child, age less than 2 years, Clinically-important traumatic brain injury (ciTBI), Computed tomography scan, Radiation exposure from CT scans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,802 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Francophone Pediatric Resuscitation and Emergency Group (GFRUP), URC-CIC Paris Descartes Necker Cochin
- Study start
- 11 Feb 2017 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 13 Feb 2017 (actual)
- 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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants aged less than two years attending at emergency departments
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Trivial head injury
- Neurosurgical history
- Pre-existing neurological disorder
- Bleeding disorder
- Suspected child abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of a clinically-important traumatic brain injuries (ciTBI)
Time frame: 7 days after head trauma
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 secondary outcomes
Rate of CT scans that would be recommended by the PELICAN rule applied in the study population
Time frame: Initial emergency clinical evaluation
Rate of CT scans that would be recommended by the PELICAN rule applied in the study population
Time frame: 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
Time frame: Initial emergency clinical evaluation
Number of patients with TBI on CT undergoing neurosurgery
Time frame: 7 days after head trauma
Rate of CT scan use in practice
Time frame: 7 days after head trauma
Number of patients with a non-clinically significant TBI identified on CT scan who would have been missed by the PELICAN rule
Time frame: 7 days after head trauma
Rate of Admission for short ED clinical observation expected by the application of PELICAN rule
Time frame: 24 hours after head trauma
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 20 Nov 2025.
- Background: PubMed 19758692Kuppermann 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.
- Background: PubMed 24431418Schonfeld 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.
- Background: PubMed 22724450Bressan 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.
- Background: PubMed 20142371Osmond 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.
- Background: PubMed 23878053Rogers 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.
- Background: PubMed 22681860Pearce 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.
- Background: PubMed 10506226Greenes 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.
- Background: PubMed 14520320Palchak 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.
- BackgroundJehlé 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
- Individual participant dataSharing planned: No
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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.
Gérard CHERON, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
Géraldine PATTEAU, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Head Trauma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 11 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 20 Nov 2025. 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 France. 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?
Presence of a clinically-important traumatic brain injuries (ciTBI) (time frame: 7 days after head trauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03050970, which also lists 9 linked publications.
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 20 Nov 2025.