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Pediatric Intensive Care Unit and Primary Immune Deficiency

NCT05629247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-11-29

No results posted yet for this study

Summary

To date, many studies have focused on the characteristics of PID in children, allowing to highlight an entry into the disease in the context of more or less severe infections in all pediatric departments. However, only one study has so far studied the frequency of these PID in a pediatric resuscitation unit, which is why we propose this study to the Caen University Hospital.

Investigtors propose a two-step study, both retrospective and prospective, in order to increase our cohort.

The retrospective analysis of the data will be done over the period 2013-2016, the prospective analysis will be done from May 2017 to January 2018. The study will be monocentric, performed in the pediatric resuscitation department of the University Hospital of Caen to evaluate the prevalence of PIDs and describe their characteristics.

The included patients will be aged 0 to 18 years, hospitalized in the pediatric intensive care unit for a serious infection and / or of an unfavorable evolution, or an opportunistic germ infection in the absence of a DIP or an immunodeficiency previously known. The inclusion will be proposed by the intensive care pediatricians. Authorization by the legal representative will be required in advance.

The data will be collected during the systematic consultation in pediatric haemato-immuno-oncology within 3 months after their hospitalization in intensive care unit to detect a DIP by a thorough interrogation, a clinical examination and a first-line biological assessment.

A second consultation will be scheduled in the 3 months following the 1st with announcement of the results of the first balance sheet and completion of a second complementary balance sheet if a suspicion of DIP persists at the end of the first balance sheet.

The precise description of the incidence of these immunodeficiencies and their characteristics could lead to the development of recommendations on the routine screening of PID in pediatric resuscitation; an early diagnosis enabling preventive and curative management (vaccine, immunoglobulin, antibiotic prophylaxis, etc.) to be put in place in order to limit the risk of infectious recurrence and reduce the morbidity.

Conditions

  • Immuno-Deficiency

Interventions

DIAGNOSTIC_TEST

Systematic screening of immune deficiency

Systematic screening of immune deficiency with blood tests

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-26
Primary Completion
2019-01-26
Completion
2020-01-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629247 on ClinicalTrials.gov