Newborn; Newborn, TransientTnTc-usNCT02880098
Variations of High Sensitivity Troponin T in Neonates
An observational study of Newborn; Newborn, Transient, run by Hôpital NOVO at 1 site in France.
Trial summary
Troponin T-us is a cardiac marker for myocardial infarction. Its use in neonates is increasing, yet normal values are still to be determined for the latest generation of tests, such as High sensitivity cardiac troponin T test. Read more about this study
- Who is it for?
- Ages 1 day to 4 daysHealthy volunteers can take part
- Conditions the study is for
- Newborn; Newborn, Transient
- What is being tested?
- Troponin T blood level
- How many people
- 497 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Mar 2017
- Phase
- Observational
- 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 1 day to 4 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children born in hospital René Dubos
Who may be able to join
- Every newborn, born alive in René Dubos maternity, without regarding the way of birth.
- Absence of malformative syndromes or genetic abnormalities in prenatal echographies
- Absence of parental opposition
Who cannot join
- Multiple pregnancies
- Post natal discovery of malformative syndromes or genetic abnormality. All congenital heart diseases will be excluded.
- Parental opposition at any time of the study
Trial locations and contacts
1 site in 1 country.
About this study
Troponin T-us is a cardiac marker for myocardial infarction. Its use in neonates is increasing, yet normal values are still to be determined for the latest generation of tests, such as High sensitivity cardiac troponin T test. This study is an observational study designed to determine biological normal values of High sensitivity cardiac troponin T test (troponin T -us) in newborns.
Read the detailed description
- Approximately 400 subjects will be recruited over a planned recruitment period of 2 months. During labour, or pre natal hospitalization, information about the study will be given to every mothers by the midwife or the pediatrician. Absence of opposition will be notified in the medical file.
- At birth, every child born alive is possibly eligible for this study, if he doesn't meet the exclusion criteria.
- After clamping the umbilical cord, the midwife realizes the systematic sample for assessment of pH and lactate. If the mother did not object to the study, the midwife will use 200µl of this very same sample to assess Troponin T blood level. This sample goes to the same laboratory to be analyzed. The blood sample for troponin T measurement must be brought to the laboratory within 2 hours, just as pH and lactate must be. The midwife in charge of this patient also fills a form with informations from the patient's medical file. This form is anonymized for the study.
- Samples will not be stored, remaining swab after analysis will be destructed.
- Before discharge, all children undergo a medical exam by a pediatrician, whether they are in maternity or in neonate. The pediatrician who examines the child fills a second form that summarizes the noteworthy events of his hospital journey.
Subjects have the right to withdraw from the study at any time for any reason. If one of the parents wishes to withdraw from the study after the first Troponin T measurement is made, we will ask for their permission to use the collected data.
- Conditions
- Newborn; Newborn, Transient
- Being tested
- Troponin T blood level
- Keywords
- Neonatology, Troponin T, Standards
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Troponin T blood levelBiological
assess Troponin T blood level for every child born from the same sample of blood (after clamping the umbilical cord) used for assessment of pH and lactate.
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of cardiac high sensitive Troponin T in umbilical cord blood
T level will be analyzed by the biochemistry laboratory and collected by a study investigator.
Measured: At birth - Time 0
Secondary outcomes (2)
Noticeable events during pregnancy ; Delivery conditions
Any event, disease, treatment during pregnancy. Those data will be collected in the mothers pregnancy file.
Measured: Within the two hours following birth
Noticeable events in post partum
Infection, jaundice… Those data will be collected in the baby's maternity file or intensive care unit file
Measured: Before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Newborn; Newborn, TransientStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BORRHOMEE Suzanne, PH, Principal investigator, suzanne.borrhomee@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880098
- Sponsor's protocol ID
- CHRD1615
- Acronym
- TnTc-us
- Status last verified
- Jul 2019
- First submitted
- 23 Aug 2016
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lefevre G. [Troponins: biological and clinical aspects]. Ann Biol Clin (Paris). 2000 Jan-Feb;58(1):39-48. French.
PubMed 10673613Adamcova M. Troponins in children and neonates. Acta Paediatr. 2003 Dec;92(12):1373-5. doi: 10.1080/08035250310007637.
PubMed 14971783Fortunato G, Carandente Giarrusso P, Martinelli P, Sglavo G, Vassallo M, Tomeo L, Rea M, Paladini D. Cardiac troponin T and amino-terminal pro-natriuretic peptide concentrations in fetuses in the second trimester and in healthy neonates. Clin Chem Lab Med. 2006;44(7):834-6. doi: 10.1515/CCLM.2006.144.
PubMed 16776629Nomura RM, Ortigosa C, Fiorelli LR, Liao AW, Zugaib M. Gender-specific differences in fetal cardiac troponin T in pregnancies complicated by placental insufficiency. Gend Med. 2011 Jun;8(3):202-8. doi: 10.1016/j.genm.2011.05.001.
PubMed 21664586
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variations of High Sensitivity Troponin T in Neonates
- ClinicalTrials.gov ID
- NCT02880098
- Acronym / sponsor ID
- TnTc-us / CHRD1615
- Conditions
- Newborn; Newborn, Transient
- Keywords
- Neonatology, Troponin T, Standards
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Aug 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.
Troponin T-us is a cardiac marker for myocardial infarction. Its use in neonates is increasing, yet normal values are still to be determined for the latest generation of tests, such as High sensitivity cardiac troponin T test. This study is an observational study designed to determine biological normal values of High sensitivity cardiac troponin T test (troponin T -us) in newborns.
Detailed description
- Approximately 400 subjects will be recruited over a planned recruitment period of 2 months. During labour, or pre natal hospitalization, information about the study will be given to every mothers by the midwife or the pediatrician. Absence of opposition will be notified in the medical file.
- At birth, every child born alive is possibly eligible for this study, if he doesn't meet the exclusion criteria.
- After clamping the umbilical cord, the midwife realizes the systematic sample for assessment of pH and lactate. If the mother did not object to the study, the midwife will use 200µl of this very same sample to assess Troponin T blood level. This sample goes to the same laboratory to be analyzed. The blood sample for troponin T measurement must be brought to the laboratory within 2 hours, just as pH and lactate must be. The midwife in charge of this patient also fills a form with informations from the patient's medical file. This form is anonymized for the study.
- Samples will not be stored, remaining swab after analysis will be destructed.
- Before discharge, all children undergo a medical exam by a pediatrician, whether they are in maternity or in neonate. The pediatrician who examines the child fills a second form that summarizes the noteworthy events of his hospital journey.
Subjects have the right to withdraw from the study at any time for any reason. If one of the parents wishes to withdraw from the study after the first Troponin T measurement is made, we will ask for their permission to use the collected data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 4 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children born in hospital René Dubos
Key inclusion criteria (3 listed)
- Every newborn, born alive in René Dubos maternity, without regarding the way of birth.
- Absence of malformative syndromes or genetic abnormalities in prenatal echographies
- Absence of parental opposition
Key exclusion criteria (3 listed)
- Multiple pregnancies
- Post natal discovery of malformative syndromes or genetic abnormality. All congenital heart diseases will be excluded.
- Parental opposition at any time of the study
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 |
|---|---|---|
| Troponin T blood levelassess Troponin T blood level for every child born from the same sample of blood (after clamping the umbilical cord) used for assessment of pH and lactate. | Biological | – |
Primary outcome
Level of cardiac high sensitive Troponin T in umbilical cord blood
Time frame: At birth - Time 0
T level will be analyzed by the biochemistry laboratory and collected by a study investigator.
2 secondary outcomes
Noticeable events during pregnancy ; Delivery conditions
Time frame: Within the two hours following birth
Noticeable events in post partum
Time frame: Before discharge
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 29 Jul 2019.
- Background: PubMed 10673613Lefevre G. [Troponins: biological and clinical aspects]. Ann Biol Clin (Paris). 2000 Jan-Feb;58(1):39-48. French.
- Background: PubMed 14971783Adamcova M. Troponins in children and neonates. Acta Paediatr. 2003 Dec;92(12):1373-5. doi: 10.1080/08035250310007637.
- Background: PubMed 16776629Fortunato G, Carandente Giarrusso P, Martinelli P, Sglavo G, Vassallo M, Tomeo L, Rea M, Paladini D. Cardiac troponin T and amino-terminal pro-natriuretic peptide concentrations in fetuses in the second trimester and in healthy neonates. Clin Chem Lab Med. 2006;44(7):834-6. doi: 10.1515/CCLM.2006.144.
- Background: PubMed 21664586Nomura RM, Ortigosa C, Fiorelli LR, Liao AW, Zugaib M. Gender-specific differences in fetal cardiac troponin T in pregnancies complicated by placental insufficiency. Gend Med. 2011 Jun;8(3):202-8. doi: 10.1016/j.genm.2011.05.001.
- Individual participant dataSharing planned: No
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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.
BORRHOMEE Suzanne, PH principal investigator
suzanne.borrhomee@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn; Newborn, Transient, run by Hôpital NOVO 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 3 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 29 Jul 2019. 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?
Level of cardiac high sensitive Troponin T in umbilical cord blood (time frame: At birth - Time 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02880098, which also lists 4 linked publications.
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 29 Jul 2019.