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Clinical Trials/NCT02787980
NCT02787980
Completed
Not Applicable

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

CHU de Reims1 site in 1 country87 target enrollmentOctober 12, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Newborns
Sponsor
CHU de Reims
Enrollment
87
Locations
1
Primary Endpoint
serum tryptase levels
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 12, 2015
End Date
December 31, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Study Sites (1)

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