- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02880098
Variations of High Sensitivity Troponin T in Neonates (TnTc-us)
July 26, 2019 updated by: Centre Hospitalier René Dubos
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
497
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Val d'Oise
-
Pontoise, Val d'Oise, France, 95303
- CH René Dubos
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 4 days (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children born in hospital René Dubos
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At birth - Time 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Noticeable events during pregnancy ; Delivery conditions
Time Frame: Within the two hours following birth
|
Any event, disease, treatment during pregnancy.
Those data will be collected in the mothers pregnancy file.
|
Within the two hours following birth
|
Noticeable events in post partum
Time Frame: Before discharge
|
Infection, jaundice… Those data will be collected in the baby's maternity file or intensive care unit file
|
Before discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: BORRHOMEE Suzanne, PH, suzanne.borrhomee@gmail.com
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lefevre G. [Troponins: biological and clinical aspects]. Ann Biol Clin (Paris). 2000 Jan-Feb;58(1):39-48. French.
- Adamcova M. Troponins in children and neonates. Acta Paediatr. 2003 Dec;92(12):1373-5. doi: 10.1080/08035250310007637.
- Fortunato 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.
- Nomura 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
August 23, 2016
First Submitted That Met QC Criteria
August 25, 2016
First Posted (Estimate)
August 26, 2016
Study Record Updates
Last Update Posted (Actual)
July 29, 2019
Last Update Submitted That Met QC Criteria
July 26, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRD1615
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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