Simultaneous Study of the Serum Tryptase Level of the Mot... | NCT04441463

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

NCT04441463

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Jun 22, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Newborn
Parturient

Interventions

Blood sampling for tryptase analysis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A01526-33	Other Identifier	ANSM

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2020Estimated

Primary Completion Date

Nov 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jun 16, 2020

First Submission Date that Met QC Criteria

Jun 18, 2020

First Posted Date

Jun 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2020

Last Update Posted Date

Jun 22, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cohort	Experimental	Mother-child couple	Biological: Blood sampling for tryptase analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lise LACLAUTRE	Contact	+33473754963		promo_interne_drci@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Maguelonne Pons	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Clermont-Ferrand		Clermont-Ferrand		63000	France

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided