eNewborn Protocol Version 1.4/13-07-2020

• Research type

  Research Database

• IRAS ID

  282578

• Research summary

  eNewborn

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  20/LO/1046

• Date of REC Opinion

  23 Sep 2020

• REC opinion

  Favourable Opinion

• Data collection arrangements

  eNewborn is a database holding a predefined list of routinely available, observational data from neonatal units around the world. eNewborn is being moved from its current location in Belgium to Imperial College London, and its remit is being extended from bench-marking to include research and other data-driven activities to improve newborn care. The data collection is being widened and will move progressively to a larger set of items (the neonatal dataset).

  All eNewborn data will be held within the secure environment of the Imperial Big Data and Analytical Unit (BDAU). The role of the BDAU will be to provide a secure data storage and processing location.

  Data submitted will comprise i) fully anonymised legacy data; ii) prospective data submitted by individual neonatal units; and iii) prospective data submitted as a bulk transfer from a group of neonatal units or national or regional registry. Prospective data will be anonymised or psedonymised depending on national/local regulations.

• Research programme

  The purpose of eNewborn is to support diverse outputs that include, but are not confined to, bench-marking, audit, quality improvement, surveillance and research to improve the care of sick newborn babies. Analyses will include but not confined to the impact of COVID-19 related illness and vaccines and treatments in pregnancy and the newborn. The community supported by eNewborn are i) the applicant team and the members of the International Investigator Group which will include a representative from each contributing country or network; and ii) external investigators conducting neonatal studies.

• Research database title

  eNewborn

• Establishment organisation

  Imperial College London

• Establishment organisation address

  Big Data and Analytical Unit

  Institute of Global Health Innovation, QEQM Building, St Mary's Hospital

  Praed Street, Imperial College London

  W2 1NY