COLLABORATE AND FIT-05/FIT-PIV STUDIES
We have several enquiries about co-enrolment into COLLABORATE and the FIT studies. PLEASE NOTE THAT CO-ENROLMENT IS PERMITTED.
Additionally, there is benefit in co-enrolment because the feeds received by FIT trial babies are the same that they would be having anyway, but in this case would be assigned by randomisation.
We would strongly support co-enrolment. The uncertainties being addressed in COLLABORATE are far too longstanding and with the help of all UK neonatal units we can finally resolve these.
COLLABORATE STUDY AND BABY FRIENDLY INITIATIVE (BFI)
The COLLABORATE team has engaged extensively with BFI. We are therefore able to provide the following advice to neonatal units:
- BFI is supportive of trying to resolve the uncertainties the study aims to address and, in a letter (September 12th, 2025) to the COLLABORATE study team stated “We accept the need for research in this area to address the uncertainty that your team have identified. The outcomes should prove to be useful for babies, parents and staff on whether donor breastmilk or preterm formula is the most suitable supplement in the absence of maternal breastmilk”.
- UK BFI has confirmed that they have a universal policy of “non-endorsement” of research; i.e., a policy of neither promoting nor opposing, any research study.
- Participation in COLLABORATE will not of itself adversely impact upon accreditation. BFI accreditation will continue to be assessed in the usual way against existing standards.
- Several neonatal units participating in COLLABORATE have full BFI accreditation including the lead neonatal units at Chelsea and Westminster Hospital, London, and the Royal Infirmary, Edinburgh, and have retained this after reassessment following the commencement of the COLLABORATE study.
Please contact COLLABORATE@imperial.ac.uk for any queries.
