TREOCAPA
Research type
Research Study
Full title
Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen
IRAS ID
300059
Contact name
Sandrine COUFFIN-CADIERGUES
Contact email
Sponsor organisation
INSERM The Institut national de la santé et de la recherche médicale
Eudract number
2019-004297-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
Treocapa is a Phase II/III European multicenter double-blind randomized trial, concerning prophylactic treatment with acetaminophen (paracetamol) for the first 5 days of life in extremely preterm infants.
Premature birth is a significant cause of infant and child morbidity and mortality. Despite technological advances and efforts of child health experts during the last 20 years, the extremely premature infant remains at high risk for death and disability with 15-30% mortality and, in survivors, at least 20-30% risk of morbidity.
The ductus arteriosus is open in all newborns at birth. Its constriction and closure are part of the normal process of postnatal adaptation. However, in many extremely preterm infants, the ductus arteriosus does not constrict itself. This defect of early constriction often persists and is a good predictor of subsequent development of patent symptomatic ductus arteriosus (PDA) which is associated with mortality and morbidity.
The use of a medication that has an effect on ductus arteriosus with fewer adverse effects, i.e. acetaminophen, could be a safe alternative to current treatments. Thus, early prophylactic treatment of ductus arteriosus by acetaminophen among many neonatologists seems to be an opportunity to reduce mortality and morbidity
Phase II is a dose finding phase in order to assess the minimum effective dose regimen (MEDR) of acetaminophen for the closure of PDA for neonates with a gestational age less than 27 weeks
Phase III is a randomized, multicenter, double-blind, placebo-controlled superiority trial, two arms in a 1:1 ratio. In the intervention arm, 20 mg/kg followed by 7.5 mg/kg quarter in die (QID) will be administered to the 27-28 weeks gestational age group (dosage confirmed through PK/PD data analysis from the previous Finnian study) and the dosage selected after the conclusion of the Phase II will be administered to the 23-26 weeks gestational age group.REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0548
Date of REC Opinion
4 Aug 2021
REC opinion
Unfavourable Opinion