Brief description of trial (Data source: BASEC)
Die TREOCAPA Studie wird durchgeführt um herauszufinden, ob die präventive Anwendung von Paracetamol bei Frühgeborenen während den ersten fünf Lebenstagen zum Verschluss des Ductus arteriosus sicher und effektiv ist und damit das Risiko für frühgeburtliche Komplikationen vermindern kann.
Health conditions investigated(Data source: BASEC)
Ductus Arteriosus bei Frühgeborenen
Health conditions
(Data source: WHO)
Patent ductus arteriosus;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
TREOCAPA ist eine internationale Studie, in der zwei Behandlungsgruppen miteinander verglichen werden: Eine Gruppe mit Paracetamol und eine Gruppe mit Placebo. Die Zuteilung in die jeweiligen Gruppen erfolgt durch das Zufallsprinzip (wie ein Münzwurf). Die Studie wird in mehr als 60 Zentren in 17 europäischen Ländern durchgeführt. Es werden insgesamt 794 Frühgeborene über eine Dauer von 28 Monaten eingeschlossen. Die Studie dauert insgesamt 38 Monate.
Interventions
(Data source: WHO)
Trade Name: Paracetamol
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: acetaminophen
Other descriptive name: PARACETAMOL
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 0.75 ml/kg-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Criteria for participation in trial
(Data source: BASEC)
Kinder geboren mit 23 - 28 Schwangerschaftswochen
Einschluss innerhalb von 12 Stunden nach Geburt
Einwilligung der Eltern
Exclusion criteria
(Data source: BASEC)
Schwere Missbildungen
Feto-fetales Transfusionssyndrom bei Zwillingen
Klinische Instabilität, die schnell zum Tod führen kann
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender:
Female: yes
Male: yes
Inclusion criteria:
? Birth between 23-26 W for Phase II, between 23-28 W for Phase III
? Post natal age < 12 hours
? Parental or Legal Authority Consent
? Parents with a social security or health insurance (if applicable)
Are the trial subjects under 18? yes
Number of subjects for this age range: 824
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
? Birth defect / Congenital anomaly
? Twin-to-twin transfusion syndrome
? Suspicion of pulmonary hypoplasia
?Suspicion of hepatic impairment (hemorrhagic syndrome and/or severe hypoglycemia)
? Clinical instability that can lead to rapid death
? Impossibility to start treatment before 12 hours of life
? Parents placed under judicial protection
? Participation in other clinical trial using acetaminophen during the first 5 days of life, indomethacin or ibuprofen during the first 3 days of life or using rescue treatment of PDA not recommended in the TREOCAPA trial
-
Further information on trial
Date trial registered
Jul 20, 2020
Incorporation of the first participant
Dec 21, 2020
Recruitment status
Not Recruiting
Academic title
(Data source: WHO)
Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen - TREOCAPA
Type of trial
(Data source: WHO)
Interventional clinical trial of medicinal product
Design of the trial
(Data source: WHO)
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
Phase
(Data source: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Primary end point
(Data source: WHO)
Main Objective: Primary objectives :
Phase II: The objective of Phase II is to define the minimum effective dose of acetaminophen to close the ductus arteriosus before or at day 7 in preterm infants of 23-26 weeks of gestation
Phase III: The primary objective is an increase in surviving without severe morbidity at 36 weeks of post menstrual age (or at discharge if it occurs before) from 50% (placebo group) to 60% in group receiving a prophylactic treatment by acetaminophen during the first 5 days of life.;Secondary Objective: Secondary objectives :
Phase II:
? Tolerance of acetaminophen at each dose
? Pharmacokinetics of acetaminophen and evaluation of the concentration-response curve (i.e., acetaminophen exposure vs. time to close the ductus arteriosus or decrease the size of ductus).
? To evaluate the relationship between acetaminophen concentration and toxicity occurrence.
Phase III:
? Early prophylactic treatment by acetaminophen decreases pain score and opiate consumption during the first 5 days of life.
? Early prophylactic treatment by acetaminophen reduces the number of back-up treatment of PDA (NSAIDs, surgery, trans-catheter procedure)
? Early prophylactic treatment by acetaminophen reduces catecholamines, opioid and parenteral nutrition requirements
? Pharmacokinetics of acetaminophen (in 50 preterms).;Primary end point(s): Primary endpoint of phase II is the closure of Ductus Arteriosus (DA) assessed by echocardiography during the first 7 days of life, defined as DA closed at two consecutive echocardiographies or if the DA is closed at echocardiography of Day 7
Primary endpoint of phase III is the survival without severe morbidity at 36 weeks of post menstrual age or at first discharge home, whichever comes first. The severe morbidities include bronchopulmonary dysplasia (BPD Grade 3 according to NIH consensus), necrotizing enterocolitis (NEC) of Bell's stage II or III, intraventricular hemorrhage (IVH) grade III-IV or cystic leukomalacia observed at any time up to 36 weeks of post menstrual age.;Timepoint(s) of evaluation of this end point: Primary endpoint of phase II will be evaluate at day 7.
Primary endpoint of phase III is evaluate at 36 weeks of post menstrual age or at first discharge home.
Secundary end point
(Data source: WHO)
Secondary end point(s): Main secondary endpoints of phase II are tolerance of acetaminophen. We will investigate:
(1) Acetaminophen serum levels
(2) Serum ALAT & ASAT
(3) Prospective clinical monitoring
(4) Adverse effects and concomitant drug exposures
Main secondary endpoints of phase III are:
(1) Number of rescue treatment to close ductus by non steroid antiinflamatory drugs (NSAIDs) or by surgery or by transcatheter.
(2) Diastolic systemic arterial pressure during the first week
(3) Early and all Pulmonary hemorrhage
(4) Cathecholamines, and opiate consumption during the first week of life
(5) Volume of enteral nutrition during the first week of life
(6) Interaction between parent involvement during the first week of life and medical care;Timepoint(s) of evaluation of this end point: At 36 weeks of post menstrual age or at first discharge home
Contact information
(Data source: WHO)
Innovative Medicines Initiative 2 (H2020 programme)
Trial results
(Data source: WHO)
Results summary
Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Geneva, Lausanne, Zurich
Countries
(Data source: WHO)
Austria, Belgium, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Italy, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. med. Christoph Rüegger
0041 43 253 98 10
christoph.rueegger@usz.ch
Contact for general information
(Data source: WHO)
Sandrine COUFFIN-CADIERGUES
8 rue de la Croix jarry
Inserm
33144 23 64 16
rqrc.siege@inserm.fr
Contact for scientific information
(Data source: WHO)
Sandrine COUFFIN-CADIERGUES
8 rue de la Croix jarry
Inserm
33144 23 64 16
rqrc.siege@inserm.fr
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
17.09.2020
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2020-01704
Secondary ID (Data source: WHO)
C19-29
2019-004297-26-FR
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