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

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

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.

Study Overview

• Status: Unknown
• Conditions: Newborn; Parturient
• Intervention / Treatment: Biological: Blood sampling for tryptase analysis

Detailed Description

• The protocole will be explain to the family in delivery room, an information note will be given, and we will let the time to think about it.
• In a second time investigator will make the mother sign a consent, that participant could retract any time then.
• A blood sample will be taken from the mother within 2 hours of delivery, using a standard blood test.
• A sample will be taken from the infant by blood drawn from the umbilical cord (non-invasive and painless sample).
• A final blood sample from your newborn will be collected at the time of the Guthrie test (systematic screening for congenital diseases) already scheduled for the new born on the third day of life.
• This blood sample will be sent to the immunology laboratory of the Clermont-Ferrand University Hospital where specific biological assays will be carried out.
• Blood samples will be stored for future use in studies.
• A collection of data concerning the child, childbirth and the results of biological analyzes will be carried out. All data will be coded.
• A phone call will be made at 3 months of life, to review the state of the child's health during his first months of life.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand
    • Principal Investigator: Maguelonne PONS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cohort; Mother-child couple	Biological: Blood sampling for tryptase analysis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of blood tryptase	blood sample for biomarker reflecting the mast cell activity	at birth (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of blood tryptase	blood sampling for biomarker reflecting the mast cell activity	day 3
Incidence of infectious disease and hospitalization	call phone for evaluation of medical condition for child by questionnaire about physical history in the past 3 months	Month 3

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Maguelonne Pons, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Biomarker; Inflammation; Newborn; Mast cell; Neonatal; Tryptase; Transplacental passage
• Other Study ID Numbers: RBHP 2020 PONS; 2020-A01526-33 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No