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Feeding Strategies Around Blood Transfusions for Necrotizing Enterocolitis (WHEAT Trial)
N/A
Recruiting
Led By Jon Dorling, MD
Research Sponsored by IWK Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from birth to date of discharge home
Awards & highlights
WHEAT Trial Summary
This trial is testing whether withholding food from premature babies around the time of a blood transfusion will reduce the occurrence of a life-threatening gut condition called NEC.
Who is the study for?
This trial is for very premature infants born before 30 weeks of gestation. It's not suitable for babies with major GIT abnormalities, those whose parents opt out, or who have had a blood transfusion with feeds or a previous episode of NEC/SIP before their first transfusion.Check my eligibility
What is being tested?
The WHEAT International trial is testing if withholding enteral feeds around the time of a blood transfusion reduces the risk of Necrotizing Enterocolitis in preterm infants compared to continuing feeding during transfusions.See study design
What are the potential side effects?
Since this trial involves standard care practices rather than new medications, side effects are related to potential outcomes of each practice rather than drug reactions. The main concern is whether withholding or continuing feeds affects NEC development.
WHEAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 40 weeks postmenstrual age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 40 weeks postmenstrual age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
NEC Stage II
Secondary outcome measures
Bronchopulmonary Dysplasia (BPD)/Chronic Lung Disease
Death
Duration of any parenteral nutrition in days
+9 moreWHEAT Trial Design
2Treatment groups
Active Control
Group I: Continuing feeds around transfusionActive Control1 Intervention
Enteral feeds will continue to be given prior, during and after the packed red cell transfusion, in the manner in which they were being given prior to the decision to transfuse. Infants will remain allocated to the same care pathway until 34(+6) weeks(+days) gestational age.
Group II: Withholding feeds around transfusionActive Control1 Intervention
All enteral feeds will be discontinued (the infant will be placed nil by mouth) for 4 hours prior to packed red cell transfusion, during the transfusion and until 4 hours post transfusion. During this period, hydration and blood glucose will be maintained according to local practice, commonly by providing parenteral nutrition or intravenous dextrose. Four hours after the red cell transfusion has finished, feeds will be recommenced to how they were being received prior to the decision to transfuse. This duration of withholding feeds will follow the approach used in other trials and observational studies, and identified as the most acceptable in a survey of UK neonatal units. It gives time for milk in the small bowel to transit into the large bowel before the transfusion and for the circulation to stabilize after the transfusion before milk feeds given into the stomach pass through into the small intestine.
Find a Location
Who is running the clinical trial?
IWK Health CentreLead Sponsor
125 Previous Clinical Trials
96,140 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,449,084 Total Patients Enrolled
Imperial College LondonOTHER
991 Previous Clinical Trials
14,904,641 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had NEC or an intestinal tear before my first blood transfusion.My parents have decided I will not participate in the trial.My infant cannot be fed through the mouth or stomach due to a major birth defect in the digestive system.My infant received a blood transfusion but was not eating by mouth at the time.
Research Study Groups:
This trial has the following groups:- Group 1: Continuing feeds around transfusion
- Group 2: Withholding feeds around transfusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being sought to join this investigation?
"Clinicaltrials.gov provides evidence that this medical trial is currently in the recruitment phase; it was initially posted on January 28th 2022 and has been subject to recent alterations as of April 22nd 2022."
Answered by AI
How many participants are being accepted for this medical research?
"Affirmative. According to records on clinicaltrials.gov, this medical study is still inviting participants to join the trial; its first post was published on January 28th 2022 and it has been edited as recently as April 22nd of that same year. The team needs 4333 individuals from a single site to enrol in the experiment."
Answered by AI
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