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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

marine.pettini@gmail.com

France1 site
  • Marine Pettini

    Nancy, 54000

Other trials in France

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 groups in NCT04973592
Study groupRoleWhat they receive
Child with Blunt Abdominal TraumaNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Characteristics of the blunt abdominal trauma studied : Trauma kinetics

    low (< 50km/h) or high (> 50km/h)

    Measured: Day 0

  3. Clinical evaluation : Pain

    visual analog scale : 0 to 10

    Measured: Day 0

  4. Clinical evaluation : Location of pain

    9 abdominal quadrants

    Measured: Day 0

  5. Clinical evaluation : Type of pain

    pain, defense or contracture

    Measured: Day 0

  6. Hemodynamic evaluation : Heart rate

    beat/min

    Measured: Day 0

  7. Hemodynamic evaluation : Blood pressure

    mmHg

    Measured: Day 0

  8. Hemodynamic evaluation : Respiratory rate

    cycle/min

    Measured: Day 0

Secondary outcomes (15)
  1. Demographic criteria of the study population : Age

    in months

    Measured: Day 0

  2. Demographic criteria of the study population : Gender

    male or female

    Measured: Day 0

  3. Time to management : Time between trauma and consultation

    minutes Management time (medical evaluation, blood work, imaging)

    Measured: Day 0

  4. Time to management : Management time

    medical evaluation, blood work, imaging

    Measured: Day 0

  5. Biological examinations : Blood count

    g/dL

    Measured: Day 0

  6. Biological examinations : Liver enzyme

    UI/L

    Measured: Day 0

  7. Biological examinations : Pancreatic enzyme

    UI/L

    Measured: Day 0

  8. Biological examinations : Coagulation test

    prothrombin time

    Measured: Day 0

  9. Biological examinations : Blood group

    G/L

    Measured: Day 0

  10. Imaging examinations : Imaging

    body scanner, abdominal-pelvic scanner or ultrasound

    Measured: Day 0

  11. Imaging examinations : Imaging findings

    presence of an effusion, hollow organ or solid organ lesion + AAST classifications

    Measured: Day 0

  12. Surgical advice

    Surgical opinion required

    Measured: Day 0

  13. Orientation

    Return home or Hospitalization Hospitalization (surgery,intensive care)

    Measured: Day 0

  14. Type of management

    Medical or surgical management

    Measured: Day 0

  15. 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.

  1. First posted22 Jul 2021
  2. Study start30 Jul 2021 (estimated)
  3. Primary completion30 Aug 2021 (estimated)
  4. Study completion30 Sep 2021 (estimated)

Resources

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)
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

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.

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