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

NCT ID: NCT02787980

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-12
• Study Completion Date: 2019-12-31

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.

Conditions

Premature Newborns

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Additional taking blood

Intervention Type: BIOLOGICAL

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

"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

Group Type: OTHER

Additional taking blood

Intervention Type: BIOLOGICAL

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

Interventions

Additional taking blood

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Reims

Reims, , France

Countries

France

Other Identifiers

PO14087

Identifier Type: -

Identifier Source: org_study_id