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Completed

NCT Number: NCT02787980

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.

Completed

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Key information

Conditions

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Reims

Reims, 51092, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Additional taking blood

Biological

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jun 2, 2016
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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