IMPROVing lifElong health and development for children and adults born very PRETERM – observational studies to enhance randomised trials for comparative effectiveness research

IMPROVE PRETERM aims to optimise the discovery and use of cost-effective, affordable and accessible interventions at birth and in early childhood to mitigate the adverse consequences of very preterm birth (VPT; <32 weeks of gestation).

These include cerebral palsy, motor and cognitive impairment, visual/auditory deficits, respiratory illnesses, and psychiatric disorders and affect lifelong health and wellbeing.

The VPT population is of high public health need as long-term outcomes are not improving despite increased survival, due to logistic and ethical challenges in generating evidence on effective interventions, leading to unstandardised and suboptimal care.Multidisciplinary, geographically diverse (13 country) research teams, working with key stakeholders (families, patients, health professionals and policymakers) will leverage advances in causal inference methods and optimise existing data sources (trials, cohort studies, birth registers, neonatal networks) within an established European federated platform for Comparative Effectiveness Research (CER).

Use Cases will compare high-priority interventions: 1) antenatal and postnatal corticosteroid treatment, 2) follow-up and intervention programmes and 3) vaccine strategies.

Capacity-building outputs will be: 1) a generalisable Lifecourse CER Framework (core outcome sets, methodological guidelines for causal inference and economic evaluation); 2) an open-source validated and standardised parent-report tool for assessing child development; 3) data sources (>30) and analytic methods on a sustainable, privacy-preserving FAIR platform.IMPROVE PRETERM will consider a broad range of patient-valued outcomes, extending current assessment periods beyond infancy, to provide holistic, cost-effective solutions for high-quality CER.

Outputs will improve the use of evidence-based care by clinicians and policymakers, reduce the preventable health burden and promote better quality of life for VPT individuals and their families.