Long Term Follow-up of the TREOCAPA Study (TREOCAPA-LT)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age23-27
SponsorInstitut National de la Santé Et de la Recherche Médicale, France
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
if the local investigator does not have up-to-date contact information allowing contact with parents
if the child's vital status cannot be ascertained
if the child is nearing the end of his life or experiencing a severe medical event as assessed by the local investigator
if the child has become subject to a legal protection measure preventing their ongoing participation in clinical research
Trial population
The study population for the follow-up study of the TREOCAPA trial consists of all children included in phase III of the trial from centres participating in the follow-up study. The parents of children who survived to two years corrected age and meet the criteria for inclusion will be offered the opportunity to complete the questionnaire.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
2 year follow-up of neurodevelopment using a parental questionnaire
Other interventionA parental questionnaire, using the PARCA-R instrument, is given to measure cognitive outcome at 2 years of corrected age for children included in the Treocapa Trial
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: patients received the investigational medicinal product acetaminophen in their first 5 days of life1 intervention
Group B: patients received the placebo (NaCl) in their first 5 days of life1 intervention
Trial outcomes
Primary outcomes
1
Non-verbal cognition at 2 years corrected age
Non-verbal cognitive (NVC) scale score from the Parent Report of Children's Abilities-Revised (PARCA-R) questionnaire, administered using an on-line parental questionnaire. The score is standardised such that it has a mean of 100 and a standard deviation of 15. Lower scores mean worse outcomes.
Time frame
from 23,5 to 27,5 months of corrected ageSecondary outcomes
1
Survival without moderate or severe cognitive impairment
Definied as survival to 2 years corrected age with a PARCA-R NVC scale score less than 2 standard deviations below the mean.
Time frame
from 23,5 to 27,5 months of corrected age2
Survival without moderate or severe neurodevelopmental impairment based on the presence of at least one of the impairments in the description :
1. the PARCA-R NVC \< 2 standard deviations below the mean; 2. moderate to severe motor impairment, as measured using parent reported questions, defined as a child unable to: walk without assistance or aids or sit or hold their head up without support19; 3. unilateral or bilateral deafness or blindness as measured by parent reported questions: if the child is deaf or has functional hearing loss requiring correction with aids but still has difficulty hearing, or if the child is blind or able to see light only19.
Time frame
from 23,5 to 27,5 months of corrected age3
Health service use and costs
Reported by parents in the questionnaire, using questions on visits to health service providers and other costs associated with care of the children that have been used in previous European studies
Time frame
from 23,5 to 27,5 months of corrected ageOther outcomes
1
Comparisons of the results with observational cohorts of very preterm infants for maternal sociodemographic characteristics
Descriptive statistics on maternal sociodemographic characteristics
Time frame
This analysis will be carried during the 12 months after the end of data collection.2
Comparisons of the results with observational cohorts of very preterm infants for gestational age
Descriptive statistics on gestational age
Time frame
This analysis will be carried during the 12 months after the end of data collection.3
Comparisons of the results with observational cohorts of very preterm infants on sex
Descriptive statistics on sex
Time frame
This analysis will be carried during the 12 months after the end of data collection.4
Comparisons of the results with observational cohorts of very preterm infants for complication of pregnancy
Descriptive statistics on complications of pregnancy
Time frame
This analysis will be carried during the 12 months after the end of data collection.Sponsors and contacts
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Source ClinicalTrials.gov