NCT02880098

Variations of High Sensitivity Troponin T in Neonates

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 497 (actual)
• Sponsor: Hôpital NOVO · Academic / Other
• Sex: All
• Age: 1 Day – 4 Days
• Healthy volunteers: Accepted

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. 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.

Conditions

• Newborn; Newborn, Transient

Interventions

Type	Name	Description
BIOLOGICAL	Troponin T blood level	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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-08-26
• Last updated: 2019-07-29

Locations

1 site across 1 country: France