Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth (TryPla)

NCT04441463 | Unknown

• 2 other identifiers: RBHP 2020 PONS2020-A01526-33
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Currently the neonatal serum level of severals proteins can be used as an indicator of subsequent risk. For example, we plan to explore the neonatal kinetics of tryptase and other immune proteins as potential markers for the risk of postnatal complications, particularly in premature babies. However, today no study has shown whether the tryptase level in the newborn is a reflection of fetal synthesis alone, or that of the mother by possible transplacental passage. There is also no database that has defined normal values for tryptase in cord blood. Our main objective is to determine the correlation between the level of maternal tryptase and that of the newborn in cord blood immediately after birth in order to estimate the transplacental passage of this molecule.

Conditions

Newborn; Parturient

Keywords

Tryptase; Neonatal; Newborn; Transplacental passage; Mast cell; Inflammation; Biomarker

Outcome Measures

Primary Outcomes (1)

• Rate of blood tryptase

  blood sample for biomarker reflecting the mast cell activity

  at birth (day 0)

Secondary Outcomes (2)

• Rate of blood tryptase

  day 3

• Incidence of infectious disease and hospitalization

  Month 3

Study Arms (1)

cohort

EXPERIMENTAL

Mother-child couple

Biological: Blood sampling for tryptase analysis

Interventions

Blood sampling for tryptase analysis BIOLOGICAL

3 bloods test * One blood sample taking from the mother's vein punction, during the delivery. * One blood sample tanking from umbilical cord. * One blood sample taking from the baby in day 3 of life, during the Guthrie test.

cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mother-child couple
• Childbirth at the Clermont-Ferrand University Hospital.
• Affiliated to a social security system

You may not qualify if:

• Newborns whose holders of parental authority are protected by law (under guardianship, placed under the protection of justice)
• Newborns whose holders of parental authority are under the age of 18
• Fetal pathology, excluding prematurity.
• emergency caesarean section, because o life threatening condition for the fetus or the mother.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Maguelonne Pons

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 22, 2020
• Study Start: September 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

FR (1)