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

Newborn Clinical Trial

— TryPla  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04441463
• Other study ID #: RBHP 2020 PONS
• Secondary ID: 2020-A01526-33
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: December 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Newborn
• Parturient

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of blood tryptase	blood sample for biomarker reflecting the mast cell activity	at birth (day 0)
Secondary	Rate of blood tryptase	blood sampling for biomarker reflecting the mast cell activity	day 3
Secondary	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