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

NCT02787980 | Completed

• 1 other identifier: PO14087
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Newborns

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients = premature newborns

OTHER

"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

"Controls" = children born full term

OTHER

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

Interventions

Additional taking blood BIOLOGICAL

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

"Controls" = children born full term; Patients = premature newborns

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: June 2, 2016
• Study Start: October 12, 2015
• Primary Completion: June 5, 2018
• Study Completion: December 31, 2019
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

FR (1)