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Completed

NCT Number: NCT02880098

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.

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Key information

Age range

1 day–4 day

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Rene Dubos

Pontoise, Val d'Oise, 95303, France

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Troponin T blood level

Biological

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Acronym: TnTc-us

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 26, 2016
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.