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WithHolding Enteral Feeds Around Blood Transfusion (International)

ConditionNecrotizing Enterocolitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorIWK Health Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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 are eligible; or minimal enteral nutrition (<15 ml/kg/day feeds) at the time of transfusion; defined as before, during and for at least 4 hours after transfusion, are eligible.

Infants who are not being fed at the time of randomization (<15ml/kg) or where enteral feeding is contraindicated [e.g. Major congenital abnormality of the gastrointestinal tract (GIT)].

Previous episode of NEC Bell stage 2 or higher or SIP prior to first study packed cell transfusion.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Withholding feeds around transfusion

    Other intervention

    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 feeds around transfusion

    Other intervention

    Continued enteral feeds

Treatment groups

4,333 Participants
are divided into 2 treatment groups
Group A: Withholding feeds around transfusionActive comparator 1 intervention
Group B: Continuing feeds around transfusionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Death

All-cause mortality

Time frame
From randomization to 40 weeks postmenstrual age
3

Late onset sepsis

Culture positive sepsis, onset after 72 hours of life

Time frame
From randomization to 40 weeks postmenstrual age
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IWK Health Centre

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Imperial College London

Collaborator

Source ClinicalTrials.gov
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