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

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.

Study Overview

• Status: Completed
• Conditions: Premature Newborns
• Intervention / Treatment: Biological: Additional taking blood

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: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Reims, France, 51092
    • CHU Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: "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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2015
• Primary Completion (Actual): June 5, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 2, 2016

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: PO14087