Registry of Pulmonary Hypertension in Neonates

Research summary

The Registry of Pulmonary Hypertension in Neonates (RePHyNe) is a prospective global multicentre observational cohort data collection study designed to collect routine clinical data including diagnostic tests and treatments delivered as part of patients’ clinical care. Participants will be recruited by clinicians working in neonatal and paediatric intensive care units who routinely provide care for neonates and young infants with pulmonary hypertension < 3 months of age,corrected for prematurity. Written informed consent will be obtained from parents/guardians. Participants will undergo clinical assessments and receive diagnostic and therapeutic interventions for PH according to local practice; they will not receive any additional intervention as a consequence of their participation in RePHyNe. The registry database will use the Research Electronic Data Capture (REDCap) system which is a secure web application for building and managing online surveys and databases (https://www.project-redcap.org/). The database will be hosted by a commercial provider,ARO,which is a UK-based,fully accredited data centre providing secure cloud services compliant with international standards (https://aro.tech/solutions/data-centre-services/). The registry dataset has been developed using formal consensus methodology techniques involving patients,families and clinicians who have contributed to core outcome set development and expert review meetings. Pseudo-anonymised,routinely collected clinical data items will be extracted from the participant’s medical records by the local research team. Data will be submitted using a series of REDCap electronic case report forms (eCRFs) via the online portal. Data items will include: • Patient demographics (e.g. date/time of birth,gestation,birth weight) • Clinical characteristics (e.g. concurrent diagnoses,measures of cardiorespiratory status) • Respiratory support parameters (e.g. ventilator/oxygen requirement) • Cardiovascular support (e.g. vasoactive medication) • Diagnostic information (e.g. baseline echocardiographic parameters,laboratory tests) • Clinical outcomes – short/long-term (e.g. mortality,chronic lung disease,long-term neurodevelopmental status)

Principal Investigator

Dr Geza Vass

Contact us

Email: neonatal.research@ouh.nhs.uk

IRAS number

345248