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

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ClinicalTrials.gov Identifier: NCT02787980
Recruitment Status : Recruiting
First Posted : June 2, 2016
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Tracking Information
First Submitted Date  ICMJE May 12, 2016
First Posted Date  ICMJE June 2, 2016
Last Update Posted Date February 25, 2019
Actual Study Start Date  ICMJE October 12, 2015
Estimated Primary Completion Date April 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity
Official Title  ICMJE Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Premature Newborns
Intervention  ICMJE Biological: Additional taking blood
Additional blood collection of 1 ml during the biological workup usually done.
Study Arms  ICMJE
  • Patients = premature newborns
    "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
    Intervention: Biological: Additional taking blood
  • "Controls" = children born full term

    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: Biological: Additional taking blood
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 26, 2016)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 12, 2019
Estimated Primary Completion Date April 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Month   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Marie Laurence POLI MEROL mpolimerol@chu-reims.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02787980
Other Study ID Numbers  ICMJE PO14087
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CHU de Reims
Study Sponsor  ICMJE CHU de Reims
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CHU de Reims
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP