Study Outline and Objectives
The overall aim of the RECAP preterm Project is to improve the health, development and quality of life of children and adults born very preterm (VPT) or with a very low birth weight (VLBW).
This aim will be achieved by combining extensive data from European cohort studies and around the world, which makes it possible to evaluate changes in outcomes over time while providing important information on how the evolution in care and survival of these high risk babies has changed their developmental outcomes and quality of life.
We want to develop a better understanding of the origins of VPT/VLBW health and developmental outcomes as well as more effective, evidence-based, personalized interventions and prevention.
RECAP preterm’s specific objectives are to:
Create a sustainable, geographically diverse and multidisciplinary platform of national and European cohorts and cohorts around the world of VPT/VLBW, constituted over a 30 year time span, to optimize the use of population data for research and innovation in healthcare and health, social and education policy.
- Establish a network and governance structure of European cohorts of children and adults born VPT/VLBW in view of sustainable exploitation and expansion, i.e., agree on and organize privacy, ethical, legal and scientific aspects, data sharing and data access
- Map previously collected cohort data and develop and apply novel analytic methodologies to harmonize data between cohorts
- Implement a data management system to pool and share harmonized data, both already collected and newly acquired
- Develop and implement an innovative eHealth based environment to engage the cohort participants (children, adults, parents, clinicians) to efficiently and sustainably collect follow-up data, and to explore new types of data collection ranging from neonatal treatment data to mood, social and physical activity monitoring of VPT/VLBW adolescents and adults
- Enable the integration of data available from existing relevant infrastructures, such as national birth registries, with the detailed individual data from the VPT/VLBW cohorts, to obtain a comprehensive picture of consequences of VPT/VLBW birth over time.
- Provide a framework for the integration of other international datasets and the development of future cohort studies.
Develop hypothesis-driven research on health and care of VPT/VLBW children and adults that builds on the unique opportunities provided by the larger sample sizes of combined cohorts and the added value of their geographic and temporal diversity to evaluate how treatment and cultural/social factors affect outcomes.
- Improve our understanding of the biological, social and environmental factors associated with survival without impairment or handicap after VPT/VLBW
- Evaluate short and long term effects of interventions currently applied for VPT/VLBW such as medication, ventilation and nutrition and their interaction with genetics, clinical factors and the social and educational environment in order to identify individualized diagnostic, preventive and therapeutic interventions
- Evaluate the use of preterm birth as a model for uncovering mechanisms that link prenatal and early life events with adult non-communicable and mental health disorders in the general European population
- Identify universal protective factors and resilience mechanisms that influence health, social and economic outcomes across European population cohorts of adults born VPT/VLBW by combining data from the integrated cohorts with those from registries to inform individualized interventions
Integrate exchange with stakeholders into the platform in order to disseminate results, to translate them into evidence-based care and policy and to ensure the platform’s sustainability.
- Stakeholders include clinicians, educators, policy makers and patient and parent associations. A special emphasis will be placed on the systematic integration of health disparities research and economic analyses into the dissemination and translation plan
Involve society; emphasize patient and public involvement (PPI) in order to reflect real-world needs and topics identified as important for families of VPT/VLBW to develop interventions which may be more successfully introduced in practice.
- Social media and mobile technology applications will be leveraged to complement traditional PPI outreach approaches, such as in-person interviews and telephone contacts