NewbornTryPlaNCT04441463
Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth (TryPla)
A study testing Blood sampling for tryptase analysis in people with Newborn and Parturient, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Newborn, Parturient
- What is being tested?
- Blood sampling for tryptase analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother-child couple
- Childbirth at the Clermont-Ferrand University Hospital.
- Affiliated to a social security system
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Maguelonne Pons
About this study
Official title: 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.
Read the 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.
- Conditions
- Newborn, Parturient
- Being tested
- Blood sampling for tryptase analysis
- Keywords
- Tryptase, Neonatal, Newborn, Transplacental passage, Mast cell, Inflammation, Biomarker
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for tryptase analysisBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| cohort | Experimental | Mother-child couple Receives: Biological: Blood sampling for tryptase analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of blood tryptase
blood sample for biomarker reflecting the mast cell activity
Measured: at birth (day 0)
Secondary outcomes (2)
Rate of blood tryptase
blood sampling for biomarker reflecting the mast cell activity
Measured: 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
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study startSep 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maguelonne Pons, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441463
- Sponsor's protocol ID
- RBHP 2020 PONS
- Other IDs
- 2020-A01526-33
- Acronym
- TryPla
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth
- ClinicalTrials.gov ID
- NCT04441463
- Acronym / sponsor ID
- TryPla / RBHP 2020 PONS
- Conditions
- Newborn, Parturient
- Keywords
- Tryptase, Neonatal, Newborn, Transplacental passage, Mast cell, Inflammation, Biomarker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | Experimental | Biological: Blood sampling for tryptase analysisMother-child couple |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Mother-child couple
- Childbirth at the Clermont-Ferrand University Hospital.
- Affiliated to a social security system
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling for tryptase analysis3 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. | Biological | cohort |
Primary outcome
Rate of blood tryptase
Time frame: at birth (day 0)
blood sample for biomarker reflecting the mast cell activity
2 secondary outcomes
Rate of blood tryptase
Time frame: day 3
Incidence of infectious disease and hospitalization
Time frame: Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maguelonne Pons principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling for tryptase analysis in people with Newborn and Parturient, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of blood tryptase (time frame: at birth (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.