Status:
UNKNOWN
Study of the Sex Differences in Inflammatory Diseases in Children
Lead Sponsor:
Queen Fabiola Children's University Hospital
Collaborating Sponsors:
Belgium Kid's Fund
Conditions:
Sex Differences in Immune Response
Acute Inflammatory Diseases in Children
Eligibility:
All Genders
6-7 years
Phase:
NA
Brief Summary
Sexual differences in innate immune response have been demonstrated and were mainly attributed to the influence of the sex steroids (1-18). However, recent clinical data revealed significant differenc...
Detailed Description
Many studies demonstrated immune differences between men and women suffering from acute and chronic inflammatory processes. In cases of acute inflammatory diseases, such as sepsis, females have better...
Eligibility Criteria
Inclusion
- Inclusion Criteria of Experimental group :
- Male (XY) and female (XX) aged from 6 months to 7 years old.
- Subject hospitalized either for:
- (1) Urinary tract infection caused by Escherichia Coli, with:
- Temperature ≥ to 38,5°C
- Urinalysis
- Leukocyte esterase +
- AND/OR Nitrites +
- AND/OR pyuria (≥ 100WBC/mm³)
- AND/OR bacteriuria.
- Urinalysis
- Clean catch voided urine: \> 10\^4 Escherichia Coli colony form unit (CFU)/mm (urine collection method for children \>3 years old or toilet trained children or by stimulation for children \<3 years old)
- Transurethral bladder catheterisation: \> 10\^4 Escherichia Coli colony form unit (CFU)/mm³ (urine collection method for children \<3 years old).
- Suprapubic aspiration: \> 1 Escherichia Coli colony form unit (CFU)/mm³ (urine collection method for children \<3 years old).
- (2) Pneumonia with pleural effusion with :
- Temperature ≥ 38,5°C
- Chest radiography/ultrasound: Pleural effusion
- Streptococcus pneumoniae identified on blood or pleural fluid culture or by PCR
- (3) Sepsis with:
- Documented or suspected infection
- Temperature \< 36° or \> 38.3°C
- Heart rhythm:
- 2 SD above normal for age
- 6-23 months: \>180/min
- 24-71 months: \>140/min
- 72-84 months: \>130/min
- Respiratory Rate:
- 6-23 months: \>35/min
- 24 - 71 months: \>30/min
- 72-84 months: \>20/min
- WBC:
- 6-23 months: \>17500/µL or \<5000/µL
- 24-71 months: \>15500/µL or \<6000/µL
- 72-84 months: \>13500/µL or \<4500/µL
- and/or CRP (blood) \> 2SD above normal
- And at least two of the following:
- PaO2/FiO2 \<300
- Proven need for \>50% FiO2 to maintain saturation ≥ 92%
- Need for mechanical ventilation
- Glasgow score \< 11
- Urine output \< 0,5mL/kg/h for at least 2h
- Creatinine:
- 6-11 months: \>0,4mg/dL
- 12-23 months: \>0,5mg/dL
- 24-59 months: \>0,8mg/dL
- 60-84 months: \>1mg/dL
- Or creatinine increase more than 0,5 mg/dL
- Platelet count \<100000/mL
- Bilirubin \>2 mg/dL
- Mean arterial pressure (MAP)
- 6-11 months: \<55 mmHg
- 12 -23 months: \<60 mmHg
- 24-59 months: \<62 mmHg
- 60-84 months: \<65 mmHg
- SBP less than two SD below normal for age
- Prolonged capillary refill: \> 5 sec
- Inclusion Criteria of Control group :
- Male (XY) and female (XX) aged from 6 months to 7 years old.
- Scheduled surgical intervention for a non-infectious pathology.
- Exclusion Criteria:
- Use of antithrombotic drugs (acetylsalicylic acid, thienopyridines, dipyridamol, glycoprotein IIb / IIIa antagonists, vitamin K antagonists, heparins).
- Congenital or acquired immunodeficiency: immunosuppressive drugs, hematopoietic stem cells transplantation, immunoglobulin therapy, extracorporeal membrane oxygenation (ECMO).
- Hemodialysis.
- 48h following cardiac operation of any type.
- Malignant cancer.
- HIV.
Exclusion
Key Trial Info
Start Date :
August 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04815811
Start Date
August 17 2019
End Date
December 31 2023
Last Update
March 25 2021
Active Locations (1)
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1
HUDERF
Brussels, Belgium, 1020