Clinical trial NCT02880098: Variations of High Sensitivity Troponin T in Neonates
Official title: Variations of High Sensitivity Troponin T in Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newborn; Newborn, Transient
Keywords: Neonatology
Troponin T
Standards
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 497
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children born in hospital René Dubos

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of cardiac high sensitive Troponin T in umbilical cord blood
timeFrame: At birth - Time 0
Secondary outcomes:
measure: Noticeable events during pregnancy ; Delivery conditions
timeFrame: Within the two hours following birth
measure: Noticeable events in post partum
timeFrame: Before discharge
Other outcomes:
Locations:
city: Pontoise
country: France
facility: CH Rene Dubos
state: Val d'Oise
Study officials:
affiliation: suzanne.borrhomee@gmail.com
name: BORRHOMEE Suzanne, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lefevre G. [Troponins: biological and clinical aspects]. Ann Biol Clin (Paris). 2000 Jan-Feb;58(1):39-48. French.
citation: Adamcova M. Troponins in children and neonates. Acta Paediatr. 2003 Dec;92(12):1373-5. doi: 10.1080/08035250310007637.
citation: 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.
citation: 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.