CClinicalTrials.gg
Status unknownNCT04973592Updated Jul 22, 2021

Evaluation of Professional Practices in the Management of Blunt Abdominal Trauma in Children in the Pediatric Emergency

An observational study in Blunt Abdominal Trauma in Children and Identifying Intra Abdominal Injuries, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2021-07-22.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
200
Ages
1 Day to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Blunt Abdominal Trauma in Children
  • Identifying Intra Abdominal Injuries

Keywords

  • Blunt abdominal trauma
  • Pediatric emergency
  • Intra-abdominal injuries
03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's planned enrollment of 200 is below the median of 353 across 714 observational studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • Patient aged 0 to 18 years consulting the Pediatric Emergency Department of the Nancy University Hospital.
  • Primary care
  • Blunt abdominal trauma

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Child with Blunt Abdominal Trauma
06

What researchers measure

Primary outcomes

  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

    Time frame: Day 0

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

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

    Time frame: Day 0

  3. Clinical evaluation : Pain

    visual analog scale : 0 to 10

    Time frame: Day 0

  4. Clinical evaluation : Location of pain

    9 abdominal quadrants

    Time frame: Day 0

  5. Clinical evaluation : Type of pain

    pain, defense or contracture

    Time frame: Day 0

  6. Hemodynamic evaluation : Heart rate

    beat/min

    Time frame: Day 0

  7. Hemodynamic evaluation : Blood pressure

    mmHg

    Time frame: Day 0

  8. Hemodynamic evaluation : Respiratory rate

    cycle/min

    Time frame: Day 0

Secondary outcomes

  1. Demographic criteria of the study population : Age

    in months

    Time frame: Day 0

  2. Demographic criteria of the study population : Gender

    male or female

    Time frame: Day 0

  3. Time to management : Time between trauma and consultation

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

    Time frame: Day 0

  4. Time to management : Management time

    medical evaluation, blood work, imaging

    Time frame: Day 0

  5. Biological examinations : Blood count

    g/dL

    Time frame: Day 0

  6. Biological examinations : Liver enzyme

    UI/L

    Time frame: Day 0

  7. Biological examinations : Pancreatic enzyme

    UI/L

    Time frame: Day 0

  8. Biological examinations : Coagulation test

    prothrombin time

    Time frame: Day 0

  9. Biological examinations : Blood group

    G/L

    Time frame: Day 0

  10. Imaging examinations : Imaging

    body scanner, abdominal-pelvic scanner or ultrasound

    Time frame: Day 0

  11. Imaging examinations : Imaging findings

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

    Time frame: Day 0

  12. Surgical advice

    Surgical opinion required

    Time frame: Day 0

  13. Orientation

    Return home or Hospitalization Hospitalization (surgery,intensive care)

    Time frame: Day 0

  14. Type of management

    Medical or surgical management

    Time frame: Day 0

  15. Second consultation at emergency

    Consultation (within 1 month)

    Time frame: 30 days

07

Study locations

1 site
  • Marine Pettini
    Nancy, 54000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04973592
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Julie LIENARD (Doctor Julie Lienard - Pediatrician specialized in visceral surgery, Central Hospital, Nancy, France) — Principal investigator
First posted
Jul 22, 2021
Start date
Jul 30, 2021 (estimated)
Primary completion
Aug 30, 2021 (estimated)
Completion
Sep 30, 2021 (estimated)
Last update
Jul 22, 2021

Study contacts

Marine Pettini
Contact
marine.pettini@gmail.com
Julie Lienard
Contact
julie.lienard@orange.fr
0383154673
Marine Pettini
principal investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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