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CompletedNCT02880098TnTc-usUpdated Jul 29, 2019

Variations of High Sensitivity Troponin T in Neonates

An observational study in Newborn; Newborn, Transient, sponsored by Hôpital NOVO. Completed at 1 site in France. Open to participants aged 1 Day to 4 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-29.

Sponsored by Hôpital NOVO · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
497
Ages
1 Day to 4 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Newborn; Newborn, Transient

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Keywords

  • Neonatology
  • Troponin T
  • Standards
03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 497 is above the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Hôpital NOVO is the lead sponsor of 69 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 4 Days
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Children born in hospital René Dubos

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
497 participants (actual)
Patient registry
No

Interventions

  • BiologicalTroponin 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.

06

What researchers measure

Primary outcomes

  1. Level of cardiac high sensitive Troponin T in umbilical cord blood

    T level will be analyzed by the biochemistry laboratory and collected by a study investigator.

    Time frame: At birth - Time 0

Secondary outcomes

  1. Noticeable events during pregnancy ; Delivery conditions

    Any event, disease, treatment during pregnancy. Those data will be collected in the mothers pregnancy file.

    Time frame: Within the two hours following birth

  2. Noticeable events in post partum

    Infection, jaundice... Those data will be collected in the baby's maternity file or intensive care unit file

    Time frame: Before discharge

07

Study locations

1 site
  • CH Rene Dubos
    Pontoise, Val d'Oise 95303, France
08

References and documents

Publications

  • Lefevre G. [Troponins: biological and clinical aspects]. Ann Biol Clin (Paris). 2000 Jan-Feb;58(1):39-48. French. PubMed 10673613 ↗
  • Adamcova M. Troponins in children and neonates. Acta Paediatr. 2003 Dec;92(12):1373-5. doi: 10.1080/08035250310007637. PubMed 14971783 ↗
  • 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. PubMed 16776629 ↗
  • 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. PubMed 21664586 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02880098
Lead sponsor
Hôpital NOVO
Responsible party
Sponsor
First posted
Aug 26, 2016
Start date
Oct 2016
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Jul 29, 2019

Study contacts

BORRHOMEE Suzanne, PH
principal investigator · suzanne.borrhomee@gmail.com

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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