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

Not Applicable

Completed

• Conditions: Premature Newborns
• Interventions: Biological: Additional taking blood

• Registration Number: NCT02787980
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-10-12
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-02
• Primary Completion: 2018-06-05
• Study Completion: 2019-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Controls" = children born full term	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
Patients = premature newborns	Additional taking blood	"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

Primary Outcome Measures

Name	Time	Method
serum tryptase levels	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

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France