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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

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.


Condition or disease Intervention/treatment Phase
Premature Newborns Biological: Additional taking blood Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity
Actual Study Start Date : October 12, 2015
Estimated Primary Completion Date : April 12, 2019
Estimated Study Completion Date : May 12, 2019

Arm Intervention/treatment
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
Biological: Additional taking blood
Additional blood collection of 1 ml during the biological workup usually done.

"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

Biological: Additional taking blood
Additional blood collection of 1 ml during the biological workup usually done.




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787980


Contacts
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Contact: Marie Laurence POLI MEROL mpolimerol@chu-reims.fr

Locations
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France
Centre Hospitalier Universitaire de Reims Recruiting
Reims, France, 51100
Contact: Marie Laurence POLI MEROL         
Sponsors and Collaborators
CHU de Reims
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02787980    
Other Study ID Numbers: PO14087
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications