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Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity

Primary Purpose

Premature Newborns

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional taking blood
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Premature Newborns

Eligibility Criteria

undefined - 1 Month (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria "Patients" :

  • all premature babies (<37 weeks of amenorrhea)
  • managed in the first 24 hours of life at the Reims university hospital
  • parents accepted to participate in the research - social security card

Inclusion Criteria "Controls" :

  • children born full term, just after each "patient" child included
  • managed in the first 24 hours of life at the Reims university hospital
  • parents accepted to participate in the research.

Exclusion Criteria "Patients" and "Controls"

  • Not managed in the first 24 hours of life at the Reims University Hospital,
  • Person, who has parental authority, protected by law,
  • Newborns with a life and death emergency in the first 24 h of life,
  • Person, who has parental authority, under age 18

Sites / Locations

  • Chu Reims

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients = premature newborns

"Controls" = children born full term

Arm Description

"Patients" will consist of all premature babies (<37 weeks of amenorrhea), managed in the first 24 hours of life at the Reims university hospital for whom parents accepted to participate in the research Additional taking blood

For "controls" the participation to research would be proposed to parents of children born full term, just after each "patient" child included. Additional taking blood

Outcomes

Primary Outcome Measures

serum tryptase levels

Secondary Outcome Measures

Full Information

First Posted
May 12, 2016
Last Updated
March 30, 2021
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT02787980
Brief Title
Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity
Official Title
Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 12, 2015 (Actual)
Primary Completion Date
June 5, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Compare serum tryptase levels of premature babies (<37 weeks of amenorrhea) to children born at full term. Study the evolution of serum tryptase levels in premature babies(<37 weeks of amenorrhea). Study the relationship between the onset of infectious complications, mainly the type of necrotizing enterocolitis seen in premature babies (<37 weeks of amenorrhea) and the evolution profile of serum tryptase levels.
Detailed Description
It seems appropriate to believe that prematurity associated or not with a genetic-related sensitivity, involving several signaling pathways, makes children more vulnerable to different environmental, infectious factors that could trigger the different pathologies of premature babies. Mast cell, via its mediators, seems to play a key role. Dosage of serum tryptase levels which is easily accessible and the work by Vitte let us imagine that the younger the child, the greater the mast cell expression, thus opening a capital pathway in the comprehension of immune system phenomena in premature babies and investigators can hope that by performing regular workups of serum tryptase levels, investigators could validate that some premature babies will express this activity in a more important manner. The relationship to eventual pathological phenomena such as necrotizing enterocolitis, but also bronchopulmonary dysplasia could then be highlighted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Newborns

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients = premature newborns
Arm Type
Other
Arm Description
"Patients" will consist of all premature babies (<37 weeks of amenorrhea), managed in the first 24 hours of life at the Reims university hospital for whom parents accepted to participate in the research Additional taking blood
Arm Title
"Controls" = children born full term
Arm Type
Other
Arm Description
For "controls" the participation to research would be proposed to parents of children born full term, just after each "patient" child included. Additional taking blood
Intervention Type
Biological
Intervention Name(s)
Additional taking blood
Intervention Description
Additional blood collection of 1 ml during the biological workup usually done.
Primary Outcome Measure Information:
Title
serum tryptase levels
Time Frame
infants born before 37 weeks of gestation:Day 1, day 7 and then every 15 days until new borns go home(up to 4 months). infants born after 37 weeks of gestation at Day 3

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria "Patients" : all premature babies (<37 weeks of amenorrhea) managed in the first 24 hours of life at the Reims university hospital parents accepted to participate in the research - social security card Inclusion Criteria "Controls" : children born full term, just after each "patient" child included managed in the first 24 hours of life at the Reims university hospital parents accepted to participate in the research. Exclusion Criteria "Patients" and "Controls" Not managed in the first 24 hours of life at the Reims University Hospital, Person, who has parental authority, protected by law, Newborns with a life and death emergency in the first 24 h of life, Person, who has parental authority, under age 18
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France

12. IPD Sharing Statement

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Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity

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