Long term Follow-up after Trials Using a European Platform of Preterm birth cohorts

The LIFT-UP Preterm project aims to create innovative tools and methods to promote RCTs in very preterm populations using the platform. The ultimate aim is to generate knowledge for better health, development and quality of life for those affected by very preterm birth.

High-quality randomised controlled trials (RCTs) propelled the advances in obstetrics and neonatal medicine that have vastly improved survival and reduced serious neonatal complications after very preterm birth. However, the number of neonatal RCTs is decreasing because of constraints imposed by the growing complexity of interventions and the costs of this research. One important constraint concerns follow-up of patients in RCTs of very preterm births which is essential for establishing long-term safety and efficacy.

The RECAP Preterm platform offers a unique opportunity to promote long-term follow-up after RCTs. In LIFT-UP we will create a data entry tool integrated into the platform, based on the open source PARCA-R questionnaire, which is a parent completed questionnaire that can be used to assess children’s cognitive and language development at 24 months of age. Other tools relate to the analysis of trial data, making it possible to compare between trials and the cohorts on the platform. These will assess the “transportability” of trial results, meaning what effects can be expected when the trial interventions are applied to very preterm infants with characteristics that may differ from those included in the trial.

Proof-of-concept study: TREOCAPA-LT

The new tools created for LIFT-UP Preterm will be implemented in a proof-of-concept study to follow up the TREOCAPA (Prophylactic treatment of the ductus arterious in preterm infants by acetaminophen) trial when the enrolled children are two years of age. TREOCAPA is a pan-European study funded by the the Conect4Children (c4c) project which aims to find out whether the preventive use of paracetamol in preterm infants during the first five days of life is safe and effective to close the ductus arteriosus blood vessel and reduces the risk of prematurity associated complications.

TREOCAPA-Long-term (LT) is following up at the age of two the children who participated in the TREOCAPA trial using the online data tool created in LIFT-UP Preterm. The aim of TREOCAPA-LT is to determine whether the preventive use of paracetamol in preterm infants during the first five days of life is safe and effective in reducing the risk of neurodevelopmental disorders in early childhood.

The TREOCAPA-LT study is funded through the MESSIDORE (Méthodologie des ESSais cliniques Innovants, Dispositifs, Outils et Recherches Exploitant les données de santé et biobanques — Innovative clinical trials methodology, Devices, tools and research using health data and biobanks) 2022 Strategic Program for Collaborative Health Research run by Inserm, the French National Institute of Health and Medical Research.