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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02787980
Enrollment
87
Registered
2016-06-02
Start date
2015-10-12
Completion date
2019-12-31
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Newborns

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.

Interventions

BIOLOGICALAdditional taking blood

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

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
serum tryptase levelsinfants 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026