Long Term Follow-up of the TREOCAPA (Prophylactic TREatment Of the duCtus Arteriosus in Preterm Infants by Acetaminophen) Study (TREOCAPA-LT)

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The ductus arteriosus (DA) is a large channel connecting the main pulmonary trunk with the descending aorta. In extremely preterm infants, the DA frequently fails to close and this results in a condition called patent ductus arteriosus (PDA). In these patients, PDA has been associated with increased mortality and morbidity in the neonatal period, and neonatal morbidities may in turn be associated with later deficits in cognitive functioning. PDA treatment with COX inhibitors, as ibuprofen or indomethacin, aiming at closing the PDA have been associated with numerous adverse effects and failed to demonstrate significant clinical benefits. Early treatment of PDA with paracetamol (acetaminophen ) has been proposed as an alternative to COX inhibitors. The ongoing pan-European TREOCAPA phase III study (NCT04459117) is a multicentre, double-blind, randomised, placebo-controlled superiority trial that assesses prophylactic use of paracetamol to improve survival without severe neonatal morbidity until discharge from hospital in infants of 23-28 weeks of gestational age. As long-term follow-up was not planned by the TREOCAPA protocol, TREOCAPA-LT study will use an existing European research infrastructure, the RECAP Preterm platform (https://recap-preterm.eu/), to follow-up the patients enrolled in the TREOCAPA trial using a parent-report questionnaire at 2 years of corrected age. The TREOCAPA-LT primary hypothesis is that there will be improved cognitive outcome at 2 years of corrected age in children born at less than 29 weeks of gestational age who were treated with paracetamol during the first 5 days of life in the TREOCAPA phase III trial.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 2
Healthy Volunteers: f
View:

• were included in the TREOCAPA phase III RCT in participating centres

• are aged between 23.5 and 27.5 months corrected age during the study period

Locations
Other Locations
France
CHU d'Angers
RECRUITING
Angers
Hôpital Femme Mère Enfant
RECRUITING
Bron
CHU de Montpellier
RECRUITING
Montpellier
CHU de Nantes
RECRUITING
Nantes
Cochin - APHP
RECRUITING
Paris
Hopital Robert Debré
RECRUITING
Paris
CHU de Strasbourg
RECRUITING
Strasbourg
CHU de Tours
RECRUITING
Tours
Contact Information
Primary
Gilles Cambonie, MD/PHD
g-cambonie@chu-montpellier.fr
+33467336609
Backup
Andrei Morgan, FRCPCH, MSc, PhD
andrei.morgan@inserm.fr
+33171722987
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2027-06
Participants
Target number of participants: 500
Treatments
patients received the investigational medicinal product acetaminophen in their first 5 days of life
This group of patients received the investigational product in their first 5 days of life during the Treocapa trial
patients received the placebo (NaCl) in their first 5 days of life
This group of patients received the placebo in their first 5 days of life during the Treocapa trial
Sponsors
Leads: Institut National de la Santé Et de la Recherche Médicale, France

This content was sourced from clinicaltrials.gov