Funding for this research was provided by:
Aspire Pharma Ltd
Received: 25 April 2022
Accepted: 12 September 2022
First Online: 21 September 2022
: Wales Research Ethics Committee 3 (Ref 19/WA/0267) has granted ethics permissions and approved all amendments. At the initial consent procedure for inclusion in the AZTEC study, the parents/guardians optionally consent to follow-up at 1 and 2 years of corrected age with an additional option to contact the infant’s general practitioner (GP). In addition, the parents/guardians can optionally consent for their babies’ data to be reviewed on relevant databases such as NHS Digital and data held in the National Neonatal Research Database (NNRD). Any participant withdrawals or deaths during the initial neonatal unit stay are communicated by the AZTEC team to the AZTEC-FU team. Continued consent is also presumed if the parents/guardians complete and return the completed questionnaire at 1 and 2 years of corrected age. The parents/guardians right to withdraw from the study at any time without affecting their infant’s clinical care is clearly communicated.
: Not applicable.
: The authors declare that they have no competing interests.