Blunt Abdominal Trauma in ChildrenNCT04973592
Evaluation of Professional Practices in the Management of Blunt Abdominal Trauma in Children in the Pediatric Emergency
An observational study of Blunt Abdominal Trauma in Children and Identifying Intra Abdominal Injuries, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The aim of our study is primarily to evaluate the professional practices over the last years in the pediatric emergencies of the Nancy's Hospital for the BATiC. This, in order to identify the traumatic mechanisms and the initial clinical elements which would make it possible to detect the patients at low risk of… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Blunt Abdominal Trauma in Children, Identifying Intra Abdominal Injuries
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2021to 30 Sep 2021
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients under 18 years of age who consulted the pediatric emergency department of the Nancy University Hospital between 08/03/2011 (first date of use of resurgences) and 22/09/2020 (end date of collection for the study) for closed abdominal trauma.
Who may be able to join
- Patient aged 0 to 18 years consulting the Pediatric Emergency Department of the Nancy University Hospital.
- Primary care
- Blunt abdominal trauma
Who cannot join
- Secondary management
- Polytrauma
- Open abdominal trauma / Penetrating wound
- Polyhandicap
- Pre-existing major digestive or urinary pathology (single kidney, renal or hepatic transplantation...)
- Pre-existing hemostasis or hepatic disorders or trauma (inborn or acquired causes)
Trial locations and contacts
1 site in 1 country.
Marine Pettini contact
About this study
Official title: Evaluation of Professional Practices in the Management of Blunt Abdominal Trauma in Children in the Pediatric Emergency Department of the Nancy's University Hospital Between 2011 and 2020 : Indentify Children at Low Risk of Intra Abdominal Injuries
The aim of our study is primarily to evaluate the professional practices over the last years in the pediatric emergencies of the Nancy's Hospital for the BATiC.
This, in order to identify the traumatic mechanisms and the initial clinical elements which would make it possible to detect the patients at low risk of developing visceral lesions. Then, a management could be proposed which would rationalize the use of additional examinations and would favor the monitoring and the clinical reassessment after the initial management of a minor trauma.
The study of the data will then aim to establish a composite score (anamnestic and clinical) of initial evaluation, from which could result a uniform management protocol (clinical, biological and imaging) of the minor BATiC, of the intermediate BATiC and the major BATiC, applicable to pediatric emergencies at the Nancy's Hospital.
Read the detailed description
For children aged 1 to 18, trauma is one of the leading causes of death, ahead of cancer and congenital malformations. The traumatic mechanisms are mainly accidents on public roads (car accidents, two-wheel accidents, accidents involving a pedestrian), sports accidents (especially cycling and horse riding), falls from a high height or onto a blunt object, and intentional or unintentional direct hits. Mortality is mainly correlated with involvement of the skull, thorax and abdomen and there is a clear male predominance (sex ratio 2 to 3 boys / 1 girl).
In France, blunt abdominal trauma in children (BATiC) is a frequent reason for consultation in pediatric emergencies. It accounts for 20 to 30% of childhood trauma, among which 10 to 30% result in potentially life-threatening intra-abdominal injuries (IAI). In order of frequency, the organs most affected are the spleen, the liver, kidneys and the pancreas. Rarely, hollow organs such as the small intestine, the duodenum, the colon, or the stomach can be affected. In rarer occasion, sores of the mesentery may be seen to.
BATiC is opposed to penetrating abdominal trauma, which accounts for only 5 to 15% of abdominal trauma in children. It is frequently part of a multiple trauma defined by "a child who has suffered a trauma whose kinetics are likely to cause at least two lesions, at least one of which can be life-threatening".
While multiple trauma accounts for only 14% of childhood trauma, it is nonetheless the main cause of death after the age of 1. For several years, this has motivated the establishment of emergency treatment protocols under the impetus of the development of "trauma centers". Therefore, polytrauma has well-codified diagnostic criteria and precise and systematic management, applicable to pediatric emergencies. Regarding the isolated BATiC, the management is less unequivocal. Although it is more frequent, BATiC with low or medium kinetics does not benefit from any clear management protocol.
Indeed, the management of a child admitted for BATiC in the pediatric emergency room does not necessarily take into account the traumatic mechanism. The course of action currently adopted involves at least an initial clinical evaluation, sometimes repeated after a period of monitoring. Then it is frequently supplemented by the performance of a blood test and imaging aimed at detecting possible IAI.
In current practice, some practitioners choose this systematic approach of BATiC, including complementary examinations from the outset, in order to never ignore an IAI. Others seem to support a more reserved attitude to the use of complementary exams when the initial assessment is reassuring. It is clear that many abdominal traumas are not complicated by any visceral injury. Especially when the traumatic mechanism is minimal and when the initial clinical evaluation does not identify elements of seriousness. In these different situations, carrying out additional examinations may indeed seem excessive.
Therefore, there is a great heterogeneity of BATiC and a strongly practitioner-dependent care which does not always take into account the minor traumatic mechanism.
Establishing a validated management protocol for BATiC, as can be the case with polytrauma, is difficult due to the great diversity of traumatic mechanisms and their variable kinetics. All the more so since the same mechanism does not systematically expose people to the same lesions depending on the child's age and its morphological characteristics. It is fundamental to take into consideration the anatomical and physiological specificities of the growing child which define his fragility in the face of abdominal trauma. Another difficulty lies in the anamnestic collection of facts which may be limited due to the child's age, his apprehension (hospital environment, reaction of the caregiver), the medical context (general condition, underlying pathology, psychological state) and the social context (particular case of mistreatment). This is all the more difficult when the trauma is not seen by a third party at all.
Several studies have already sought to define predictive scores for IAI. These scores are established after performing additional laboratory tests and almost always include performing an abdominal ultrasound. They have the advantage of reducing the use of the scanner, thus exposure to ionizing rays, but do not simplify the management of minor trauma for which it would be possible not to perform additional examinations at all, if they are defined beforehand.
Retrospective study of the anamnestic and clinical elements of patients without any IAI could allow the identification of clinical situations in which the performance of complementary examinations is not necessary. In this way, the course of action for minor trauma could be simplified by promoting surveillance and clinical reassessment rather than the routine use of additional tests, thereby reducing the time spent in the pediatric emergency room.
- Keywords
- Blunt abdominal trauma, Pediatric emergency, Intra-abdominal injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Child with Blunt Abdominal Trauma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of the blunt abdominal trauma studied : Trauma mechanisms
fall from a bicycle, a horse, a height, road - belted or unbelted accident, two-wheeler accident, blows inflicted
Measured: Day 0
Characteristics of the blunt abdominal trauma studied : Trauma kinetics
low (< 50km/h) or high (> 50km/h)
Measured: Day 0
Clinical evaluation : Pain
visual analog scale : 0 to 10
Measured: Day 0
Clinical evaluation : Location of pain
9 abdominal quadrants
Measured: Day 0
Clinical evaluation : Type of pain
pain, defense or contracture
Measured: Day 0
Hemodynamic evaluation : Heart rate
beat/min
Measured: Day 0
Hemodynamic evaluation : Blood pressure
mmHg
Measured: Day 0
Hemodynamic evaluation : Respiratory rate
cycle/min
Measured: Day 0
Secondary outcomes (15)
Demographic criteria of the study population : Age
in months
Measured: Day 0
Demographic criteria of the study population : Gender
male or female
Measured: Day 0
Time to management : Time between trauma and consultation
minutes Management time (medical evaluation, blood work, imaging)
Measured: Day 0
Time to management : Management time
medical evaluation, blood work, imaging
Measured: Day 0
Biological examinations : Blood count
g/dL
Measured: Day 0
Biological examinations : Liver enzyme
UI/L
Measured: Day 0
Biological examinations : Pancreatic enzyme
UI/L
Measured: Day 0
Biological examinations : Coagulation test
prothrombin time
Measured: Day 0
Biological examinations : Blood group
G/L
Measured: Day 0
Imaging examinations : Imaging
body scanner, abdominal-pelvic scanner or ultrasound
Measured: Day 0
Imaging examinations : Imaging findings
presence of an effusion, hollow organ or solid organ lesion + AAST classifications
Measured: Day 0
Surgical advice
Surgical opinion required
Measured: Day 0
Orientation
Return home or Hospitalization Hospitalization (surgery,intensive care)
Measured: Day 0
Type of management
Medical or surgical management
Measured: Day 0
Second consultation at emergency
Consultation (within 1 month)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start30 Jul 2021 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blunt Abdominal Trauma in ChildrenStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie LIENARD, Central Hospital, Nancy, France
- Investigators
- Marine Pettini, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973592
- Sponsor's protocol ID
- 2020PI292
- Status last verified
- Jul 2021
- First submitted
- 12 May 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Professional Practices in the Management of Blunt Abdominal Trauma in Children in the Pediatric Emergency Department of the Nancy's University Hospital Between 2011 and 2020 : Indentify Children at Low Risk of Intra Abdominal Injuries
- ClinicalTrials.gov ID
- NCT04973592
- Acronym / sponsor ID
- 2020PI292
- Keywords
- Blunt abdominal trauma, Pediatric emergency, Intra-abdominal injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 22 Jul 2021 (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 aim of our study is primarily to evaluate the professional practices over the last years in the pediatric emergencies of the Nancy's Hospital for the BATiC.
This, in order to identify the traumatic mechanisms and the initial clinical elements which would make it possible to detect the patients at low risk of developing visceral lesions. Then, a management could be proposed which would rationalize the use of additional examinations and would favor the monitoring and the clinical reassessment after the initial management of a minor trauma.
The study of the data will then aim to establish a composite score (anamnestic and clinical) of initial evaluation, from which could result a uniform management protocol (clinical, biological and imaging) of the minor BATiC, of the intermediate BATiC and the major BATiC, applicable to pediatric emergencies at the Nancy's Hospital.
Detailed description
For children aged 1 to 18, trauma is one of the leading causes of death, ahead of cancer and congenital malformations. The traumatic mechanisms are mainly accidents on public roads (car accidents, two-wheel accidents, accidents involving a pedestrian), sports accidents (especially cycling and horse riding), falls from a high height or onto a blunt object, and intentional or unintentional direct hits. Mortality is mainly correlated with involvement of the skull, thorax and abdomen and there is a clear male predominance (sex ratio 2 to 3 boys / 1 girl).
In France, blunt abdominal trauma in children (BATiC) is a frequent reason for consultation in pediatric emergencies. It accounts for 20 to 30% of childhood trauma, among which 10 to 30% result in potentially life-threatening intra-abdominal injuries (IAI). In order of frequency, the organs most affected are the spleen, the liver, kidneys and the pancreas. Rarely, hollow organs such as the small intestine, the duodenum, the colon, or the stomach can be affected. In rarer occasion, sores of the mesentery may be seen to.
BATiC is opposed to penetrating abdominal trauma, which accounts for only 5 to 15% of abdominal trauma in children. It is frequently part of a multiple trauma defined by "a child who has suffered a trauma whose kinetics are likely to cause at least two lesions, at least one of which can be life-threatening".
While multiple trauma accounts for only 14% of childhood trauma, it is nonetheless the main cause of death after the age of 1. For several years, this has motivated the establishment of emergency treatment protocols under the impetus of the development of "trauma centers". Therefore, polytrauma has well-codified diagnostic criteria and precise and systematic management, applicable to pediatric emergencies. Regarding the isolated BATiC, the management is less unequivocal. Although it is more frequent, BATiC with low or medium kinetics does not benefit from any clear management protocol.
Indeed, the management of a child admitted for BATiC in the pediatric emergency room does not necessarily take into account the traumatic mechanism. The course of action currently adopted involves at least an initial clinical evaluation, sometimes repeated after a period of monitoring. Then it is frequently supplemented by the performance of a blood test and imaging aimed at detecting possible IAI.
In current practice, some practitioners choose this systematic approach of BATiC, including complementary examinations from the outset, in order to never ignore an IAI. Others seem to support a more reserved attitude to the use of complementary exams when the initial assessment is reassuring. It is clear that many abdominal traumas are not complicated by any visceral injury. Especially when the traumatic mechanism is minimal and when the initial clinical evaluation does not identify elements of seriousness. In these different situations, carrying out additional examinations may indeed seem excessive.
Therefore, there is a great heterogeneity of BATiC and a strongly practitioner-dependent care which does not always take into account the minor traumatic mechanism.
Establishing a validated management protocol for BATiC, as can be the case with polytrauma, is difficult due to the great diversity of traumatic mechanisms and their variable kinetics. All the more so since the same mechanism does not systematically expose people to the same lesions depending on the child's age and its morphological characteristics. It is fundamental to take into consideration the anatomical and physiological specificities of the growing child which define his fragility in the face of abdominal trauma. Another difficulty lies in the anamnestic collection of facts which may be limited due to the child's age, his apprehension (hospital environment, reaction of the caregiver), the medical context (general condition, underlying pathology, psychological state) and the social context (particular case of mistreatment). This is all the more difficult when the trauma is not seen by a third party at all.
Several studies have already sought to define predictive scores for IAI. These scores are established after performing additional laboratory tests and almost always include performing an abdominal ultrasound. They have the advantage of reducing the use of the scanner, thus exposure to ionizing rays, but do not simplify the management of minor trauma for which it would be possible not to perform additional examinations at all, if they are defined beforehand.
Retrospective study of the anamnestic and clinical elements of patients without any IAI could allow the identification of clinical situations in which the performance of complementary examinations is not necessary. In this way, the course of action for minor trauma could be simplified by promoting surveillance and clinical reassessment rather than the routine use of additional tests, thereby reducing the time spent in the pediatric emergency room.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Child with Blunt Abdominal Trauma | – | – |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients under 18 years of age who consulted the pediatric emergency department of the Nancy University Hospital between 08/03/2011 (first date of use of resurgences) and 22/09/2020 (end date of collection for the study) for closed abdominal trauma.
Key inclusion criteria (3 listed)
- Patient aged 0 to 18 years consulting the Pediatric Emergency Department of the Nancy University Hospital.
- Primary care
- Blunt abdominal trauma
Key exclusion criteria (6 listed)
- Secondary management
- Polytrauma
- Open abdominal trauma / Penetrating wound
- Polyhandicap
- Pre-existing major digestive or urinary pathology (single kidney, renal or hepatic transplantation...)
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
Characteristics of the blunt abdominal trauma studied : Trauma mechanisms
Time frame: Day 0
fall from a bicycle, a horse, a height, road - belted or unbelted accident, two-wheeler accident, blows inflicted
Characteristics of the blunt abdominal trauma studied : Trauma kinetics
Time frame: Day 0
low (< 50km/h) or high (> 50km/h)
Clinical evaluation : Pain
Time frame: Day 0
visual analog scale : 0 to 10
Clinical evaluation : Location of pain
Time frame: Day 0
9 abdominal quadrants
Clinical evaluation : Type of pain
Time frame: Day 0
pain, defense or contracture
Hemodynamic evaluation : Heart rate
Time frame: Day 0
beat/min
Hemodynamic evaluation : Blood pressure
Time frame: Day 0
mmHg
Hemodynamic evaluation : Respiratory rate
Time frame: Day 0
cycle/min
15 secondary outcomes
Demographic criteria of the study population : Age
Time frame: Day 0
Demographic criteria of the study population : Gender
Time frame: Day 0
Time to management : Time between trauma and consultation
Time frame: Day 0
Time to management : Management time
Time frame: Day 0
Biological examinations : Blood count
Time frame: Day 0
Biological examinations : Liver enzyme
Time frame: Day 0
Biological examinations : Pancreatic enzyme
Time frame: Day 0
Biological examinations : Coagulation test
Time frame: Day 0
Biological examinations : Blood group
Time frame: Day 0
Imaging examinations : Imaging
Time frame: Day 0
Imaging examinations : Imaging findings
Time frame: Day 0
Surgical advice
Time frame: Day 0
Orientation
Time frame: Day 0
Type of management
Time frame: Day 0
Second consultation at emergency
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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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.
Marine Pettini contact
Marine Pettini principal investigator
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 Blunt Abdominal Trauma in Children and Identifying Intra Abdominal Injuries, run by Central Hospital, Nancy, France 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 6 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: status not confirmed, as of the sponsor's last update on 22 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marine Pettini (marine.pettini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of the blunt abdominal trauma studied : Trauma mechanisms (time frame: Day 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2021.