Newborn Clinical Trial - Simultaneous Study of the Serum Tryptase Level of

Status Not yet recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04441463
Study type	Interventional
Source	University Hospital, Clermont-Ferrand
Contact	Lise LACLAUTRE
Phone	+33473754963
Email	promo_interne_drci@chu-clermontferrand.fr
Status	Not yet recruiting
Phase	N/A
Start date	September 2020
Completion date	December 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms