important infoRMATION & USEFUL REMINDERS

If you are a Healthcare Professional working in a Neonatal Unit taking part in the WHEAT Trial, please familiarise yourself with a few key points about the trial:

REGULATORY REQUIREMENTS

Before undertaking any work on the WHEAT Trial, you must have made contact with your local Principal Investigator and have undergone training on the trial.

TRAINING VIDEO

Below is a 20 minute video (based on Protocol V1.3) which will give you an overview of the key points of the trial and associated procedures. Email WHEAT@imperial.ac.uk for any queries.

ELIGIBILITY

Babies are eligible for WHEAT if they meet the following criteria:

Inclusion Criteria

  • Preterm birth at <30+0 gestational weeks + days

Exclusion Criteria

  • Parent(s) opt-out of trial participation.

  • Packed red cell transfusion with concurrent enteral feeds prior to enrolment. Infants who have received a packed red cell transfusion while nil-by-mouth or minimal enteral nutrition (<15ml/kg/day feeds) - 4 hours before during and after - are eligible.

  • Infants who are not being fed at the time of randomisation or where enteral feeding is contraindicated, for example major congenital abnormality of the gastrointestinal tract

  • Previous episode of necrotising enterocolitis (NEC) or spontaneous intestinal perforation (SIP) prior to first packed cell transfusion.

In the UK, Badger has been configured at recruiting sites to (partially) automatically detect an eligible baby based on the age of the baby in the clinical summary entered on admission.

RANDOMISATION

This only takes place once the baby requires a packed red cell transfusion and if the baby remains <35 weeks corrected gestational age.

Randomisation must take place at least 4 hours prior to the transfusion, as feeds are to be withheld for 4 hours prior to each transfusion if allocated to that arm.

See the Trial Procedures Guide (UK) or Randomization Manual (Canada) under the Trial Document Portal for more details.

TRIAL INTERVENTION

Feeds should be continued or withheld at each blood transfusion from the point of randomisation until the baby reaches 35 weeks corrected gestational age.

Continue Feeds - Babies should have enteral feeds continued throughout each transfusion according to local practice.

Withhold Feeds - Babies should have enteral feeds paused 4hrs before, during and 4hrs post transfusion.

DATA COLLECTION

Canada

You should have access to the REDCap database. Please contact our Canadian team if you need access.

UK

Data collection for WHEAT is embedded into EPR at participating UK sites. There are no additional databases or forms to complete.

TRIAL DOCUMENT PORTAL

Canada Trial Documents

UK Trial Documents

are you considering additional sites?

We are always open to considering new sites in the UK and Canada, so please get in touch with us using the links below to complete a contact form. One of our Trial Managers will get back to you shortly.

WANT TO GET IN TOUCH WITH US?

Click the appropriate link below for country-specific support:

Please note that contacts are only monitored during usual working hours (Mon-Fri 9am-5pm). If you have a clinical emergency, please contact your local Principal Investigator (PI) and/or Lead Nurse.