An interventional study of Withholding feeds around transfusion and Continued feeds around transfusion in Necrotizing Enterocolitis, sponsored by IWK Health Centre. Recruiting at 40 sites in 2 countries. Open to participants aged Up to 30 Weeks. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by IWK Health Centre · Not applicable, Interventional, and Other
The WHEAT International trial is a comparative effectiveness trial exploring whether withholding enteral feeds around the time of blood transfusion in very premature infants (\<30 weeks) will reduce the occurrence of Necrotizing Enterocolitis (NEC). Currently both continued feeding and withholding feeding are approved care practices. The current study will randomize infants from Neonatal Intensive Care Units (NICUs) across Canada and the United Kingdom (UK) into one of the two care approaches (withholding or continued feeds) to determine if any significant outcomes are found.
BACKGROUND: Necrotizing enterocolitis (NEC) is a devastating disease that affects mostly the intestine of premature infants. The wall of the intestine is invaded by bacteria, which cause local infection and inflammation that can ultimately destroy the wall of the bowel (intestine). NEC is among the most potentially devastating neonatal diseases and has a mortality of up to 33%, the most severe form (requiring surgery or resulting in death) affects about 5% of infants born at less than 30 gestational weeks; survivors are at high risk of long-term health and developmental problems. Prevention of NEC has been identified as one of the most important research uncertainties in the field of preterm birth. A temporal association between red cell transfusion and the subsequent development of the disease is well described. This 'transfusion-associated NEC' may also be more severe with higher mortality. Very preterm or extremely low birth weight infants are among the most frequently transfused patients: between 56% and 90-95% have at least one transfusion, and those transfused received an average of 5 transfusions in their neonatal stay. Withholding milk feeds during red cell transfusion may reduce the risk of NEC by decreasing postprandial mesenteric ischemia but there may be harmful effects of pausing enteral feeds. However, due to a lack of good quality evidence, there is no consensus regarding the optimal feeding strategy during a blood transfusion.
Both comparator pathways of care are standard practice in Canada and the UK; the WHEAT trial is a comparative effectiveness trial. The two care pathways that will be compared are:
Infants will remain allocated to the same care pathway until 34(+6) weeks(+days) gestational age.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 4,333 is above the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →IWK Health Centre is the lead sponsor of 86 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Preterm birth at \<30+0 gestational weeks + days
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Withholding feeds around transfusion
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.
Other: Continued feeds around transfusion
Withholding enteral feeds for preterm infants (\<30 weeks) around the time of blood transfusions to determine if any impact on the development and/or severity of Necrotizing Enterocolitis.
Continued enteral feeds
NEC Stage II
Stage II or greater NEC recorded after the first trial blood transfusion; defined according to the modified Bell staging criteria: based on clinical features and abdominal imaging findings, or on surgical or histological findings of NEC.
Time frame: From randomization to 40 weeks postmenstrual age
Severe NEC
Histologically or surgically confirmed or recorded on the death certificate. These infants will be identified as described in Battersby et al. which will include infants recorded as being transferred for surgery.
Time frame: From randomization to 40 weeks postmenstrual age
Death
All-cause mortality
Time frame: From randomization to 40 weeks postmenstrual age
Late onset sepsis
Culture positive sepsis, onset after 72 hours of life
Time frame: From randomization to 40 weeks postmenstrual age
Number of days with a central venous line in situ
Number of days with a central venous line in situ
Time frame: From birth to date of discharge home
Number of central line associated bloodstream infections
Number of central line associated bloodstream infections: Positive blood culture confirmed bloodstream infection
Time frame: From randomization to 40 weeks postmenstrual age
Duration of any parenteral nutrition in days
Duration of any parenteral nutrition in days
Time frame: From birth to 40 weeks postmenstrual age
Growth
Weight and head circumference z score.
Time frame: At date of discharge home
Spontaneous Intestinal Perforation
Histologically or surgically confirmed or recorded in the death certificate.
Time frame: From randomization to 40 weeks postmenstrual age
Duration of hospital stay
Total duration of neonatal care in days including all levels of care (intensive care, high dependency care, special care and ordinary care)
Time frame: From birth to date of discharge home
Bronchopulmonary Dysplasia (BPD)/Chronic Lung Disease
Requiring respiratory support at 36 weeks gestation
Time frame: At 36 weeks postmenstrual age
Retinopathy of prematurity (ROP)
ROP requiring treatment
Time frame: From randomization to 40 weeks postmenstrual age
Severe Brain Injury
Intraventricular haemorrhage (IVH) grade 3 or 4 or cystic periventricular leukomalacia (PVL)
Time frame: At 40 weeks postmenstrual age
Plan to share: Yes — De-identified participant data, the data dictionary, statistical code and other study materials.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Made available following publication of the primary results manuscript (for 10 years).
Access criteria: Access will be considered by the trial team and sponsors, in accordance with participant confidentiality, consent permissions, ethics approvals and applicable data protection requirements.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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