Premature NewbornsNCT02787980
Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity
A study testing Additional taking blood in people with Premature Newborns, run by CHU de Reims at 1 site in France.
Trial summary
Compare serum tryptase levels of premature babies (<37 weeks of amenorrhea) to children born at full term. Study the evolution of serum tryptase levels in premature babies(<37 weeks of amenorrhea). Read more about this study
- Who is it for?
- Ages Up to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Premature Newborns
- What is being tested?
- Additional taking blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2015to 31 Dec 2019
- 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 Up to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- all premature babies (<37 weeks of amenorrhea)
- managed in the first 24 hours of life at the Reims university hospital
- parents accepted to participate in the research - social security card
- children born full term, just after each "patient" child included
- managed in the first 24 hours of life at the Reims university hospital
- parents accepted to participate in the research.
Who cannot join
- Not managed in the first 24 hours of life at the Reims University Hospital,
- Person, who has parental authority, protected by law,
- Newborns with a life and death emergency in the first 24 h of life,
- Person, who has parental authority, under age 18
Trial locations and contacts
1 site in 1 country.
About this study
Compare serum tryptase levels of premature babies (<37 weeks of amenorrhea) to children born at full term.
Study the evolution of serum tryptase levels in premature babies(<37 weeks of amenorrhea). Study the relationship between the onset of infectious complications, mainly the type of necrotizing enterocolitis seen in premature babies (<37 weeks of amenorrhea) and the evolution profile of serum tryptase levels.
Read the detailed description
It seems appropriate to believe that prematurity associated or not with a genetic-related sensitivity, involving several signaling pathways, makes children more vulnerable to different environmental, infectious factors that could trigger the different pathologies of premature babies. Mast cell, via its mediators, seems to play a key role.
Dosage of serum tryptase levels which is easily accessible and the work by Vitte let us imagine that the younger the child, the greater the mast cell expression, thus opening a capital pathway in the comprehension of immune system phenomena in premature babies and investigators can hope that by performing regular workups of serum tryptase levels, investigators could validate that some premature babies will express this activity in a more important manner. The relationship to eventual pathological phenomena such as necrotizing enterocolitis, but also bronchopulmonary dysplasia could then be highlighted.
- Conditions
- Premature Newborns
- Being tested
- Additional taking blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional taking bloodBiological
Additional blood collection of 1 ml during the biological workup usually done.
| Study group | Role | What they receive |
|---|---|---|
| Patients = premature newborns | Other | "Patients" will consist of all premature babies (<37 weeks of amenorrhea), managed in the first 24 hours of life at the Reims university hospital for whom parents accepted to participate in the research Additional taking blood Receives: Biological: Additional taking blood |
| "Controls" = children born full term | Other | For "controls" the participation to research would be proposed to parents of children born full term, just after each "patient" child included.
Additional taking blood Receives: Biological: Additional taking blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum tryptase levels
Measured: infants born before 37 weeks of gestation:Day 1, day 7 and then every 15 days until new borns go home(up to 4 months). infants born after 37 weeks of gestation at Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start12 Oct 2015
- Primary completion5 Jun 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature NewbornsStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787980
- Sponsor's protocol ID
- PO14087
- Status last verified
- Mar 2021
- First submitted
- 12 May 2016
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity
- ClinicalTrials.gov ID
- NCT02787980
- Acronym / sponsor ID
- PO14087
- Conditions
- Premature Newborns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 12 Oct 2015 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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.
Compare serum tryptase levels of premature babies (<37 weeks of amenorrhea) to children born at full term.
Study the evolution of serum tryptase levels in premature babies(<37 weeks of amenorrhea). Study the relationship between the onset of infectious complications, mainly the type of necrotizing enterocolitis seen in premature babies (<37 weeks of amenorrhea) and the evolution profile of serum tryptase levels.
Detailed description
It seems appropriate to believe that prematurity associated or not with a genetic-related sensitivity, involving several signaling pathways, makes children more vulnerable to different environmental, infectious factors that could trigger the different pathologies of premature babies. Mast cell, via its mediators, seems to play a key role.
Dosage of serum tryptase levels which is easily accessible and the work by Vitte let us imagine that the younger the child, the greater the mast cell expression, thus opening a capital pathway in the comprehension of immune system phenomena in premature babies and investigators can hope that by performing regular workups of serum tryptase levels, investigators could validate that some premature babies will express this activity in a more important manner. The relationship to eventual pathological phenomena such as necrotizing enterocolitis, but also bronchopulmonary dysplasia could then be highlighted.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients = premature newborns | Other | Biological: Additional taking blood"Patients" will consist of all premature babies (<37 weeks of amenorrhea), managed in the first 24 hours of life at the Reims university hospital for whom parents accepted to participate in the research Additional taking blood |
| "Controls" = children born full term | Other | Biological: Additional taking bloodFor "controls" the participation to research would be proposed to parents of children born full term, just after each "patient" child included. Additional taking blood |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- all premature babies (<37 weeks of amenorrhea)
- managed in the first 24 hours of life at the Reims university hospital
- parents accepted to participate in the research - social security card
- children born full term, just after each "patient" child included
- managed in the first 24 hours of life at the Reims university hospital
Key exclusion criteria (4 listed)
- Not managed in the first 24 hours of life at the Reims University Hospital,
- Person, who has parental authority, protected by law,
- Newborns with a life and death emergency in the first 24 h of life,
- Person, who has parental authority, under age 18
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 |
|---|---|---|
| Additional taking bloodAdditional blood collection of 1 ml during the biological workup usually done. | Biological | "Controls" = children born full term, Patients = premature newborns |
Primary outcome
serum tryptase levels
Time frame: infants born before 37 weeks of gestation:Day 1, day 7 and then every 15 days until new borns go home(up to 4 months). infants born after 37 weeks of gestation at Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional taking blood in people with Premature Newborns, run by CHU de Reims 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 6 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: finished, as of the sponsor's last update on 1 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum tryptase levels (time frame: infants born before 37 weeks of gestation:Day 1, day 7 and then every 15 days until new borns go home(up to 4 months). infants born after 37 weeks of gestation at Day 3). 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 1 Apr 2021.