We have completed recruitment of 799 babies to the AZTEC trial. The trial has involved 28 neonatal intensive care units and over 50 step-down units around the UK. We are delighted with the incredible support we have received from the parents their babies as well as the doctors and nurses looking after these babies throughout the UK.
All the information collected about your baby during the study will be handled according to all applicable ethical and legal requirements.
Your baby’s personal information will be kept strictly confidential and will only be accessed by people working on the study or working to ensure the study is being run correctly.
Every effort will be made to ensure that any information about your baby that leaves the hospital will have your baby’s identifiers removed so that your baby cannot be recognised from it; this information will usually be removed by a member of the study team at your baby’s hospital but may also be removed by the Centre for Trials Research upon receipt.
What happens if I change my mind about my baby taking part?
If at any point you decide you want your baby to stop taking part in the study, the care your baby receives will not be affected. If you do decide for your baby to stop taking part we would stop giving study treatment (if not finished) and ask you if you would like your baby to:
- continue to complete study follow up (data collection and whether stool/fluid samples can be taken),
- continue to be followed up at 1 and at 2 years of age, or
- stop taking part with no more study follow up.
If you withdraw your baby from the study, we will keep the information about your baby that we have already obtained. We may be required to collect some limited information about your baby and about side effects your baby may have as a result of taking part in the trial. This will only be collected if required by the Regulatory Authorities.
Please let us know if your family circumstances change, e.g. you move house or change your phone number, so that we can keep in touch with you. We would like to notify you of the results of the AZTEC trial when published and would like to get in touch with information about follow up.
We are keeping in contact with families who were involved in the main AZTEC trial to carry out a follow up analysis of each baby at 1 and 2 years of age to ensure that all remains well. We shall mail you a questionnaire to complete asking about your child’s health and well-being at one and two years of age.
More information is available at: https://www.isrctn.com/ISRCTN47442783.