Clinical trial NCT04441463: Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth (TryPla)
Official title: Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Newborn
Parturient
Keywords: Tryptase
Neonatal
Newborn
Transplacental passage
Mast cell
Inflammation
Biomarker
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of blood tryptase
timeFrame: at birth (day 0)
Secondary outcomes:
measure: Rate of blood tryptase
timeFrame: day 3
measure: Incidence of infectious disease and hospitalization
timeFrame: Month 3
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Maguelonne Pons
role: PRINCIPAL_INVESTIGATOR
References: