Newborn; Newborn, Transient Clinical Trial
Official title:
Variations of High Sensitivity Troponin T in Neonates
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.
- 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.
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