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

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.

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.

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

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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