RecruitingACTRN12619000711112

WithHolding or continuing Enteral feeds Around blood Transfusion (WHEAT) to prevent necrotising enterocolitis (NEC) in preterm infants

WithHolding or continuing Enteral feeds Around blood Transfusion (WHEAT) to prevent necrotising enterocolitis (NEC) in preterm infants: The Australian arm of the multinational WHEAT International collaboration

Sponsor

Australian and New Zealand Neonatal Network

Enrollment

4,437 participants

Start Date

Jan 10, 2020

Study Type

Interventional

Conditions

Necrotising Enterocolitis

Summary

Necrotising Enterocolitis (NEC) is a devastating neonatal disease associated with high risks of death and disability. The pathogenesis of NEC is incompletely understood but we know there is a temporal association between red cell transfusion and NEC. There is uncertainty about the impact of feeding during red cell transfusions and how this affects the chance of developing NEC. WHEAT aims to answer: In infants born <30 weeks (Patient), does withholding enteral feeds around the time of blood transfusion (Intervention), versus continued feeding around the time of blood transfusion (Comparator), reduce the rate of NEC after the first transfusion (Outcome)? Design/methods: Randomised, controlled, unblinded, multi-centre, comparative effectiveness superiority trial of two clinical care pathways. The two care pathways are: (1) Withholding feeds around transfusion; (2) Continuing feeds around transfusion. Expected outcomes: If withholding or continuing feeds during transfusion reduces the incidence of NEC, adopting this practice will help to improve preterm outcomes.

Eligibility

Sex: Both males and femalesMax Age: 3 Monthss

Plain Language Summary

Simplified for easier understanding

Necrotising enterocolitis (NEC) is a devastating and potentially fatal intestinal disease that primarily affects very premature babies. It causes the tissue in the bowel to become inflamed and, in serious cases, to die. Doctors have noticed that NEC sometimes develops shortly after a premature baby receives a blood transfusion, but it is not clear whether this is linked to feeding at the time of the transfusion. The WHEAT trial is investigating whether pausing feeds around the time of a blood transfusion reduces the risk of NEC compared to continuing feeds as normal. Babies born before 30 weeks gestation who need a blood transfusion will be enrolled in this multicentre trial across Australia and New Zealand. Their parents (or guardians) can choose to opt out if they prefer not to participate. This study is relevant to families of extremely premature babies admitted to a neonatal intensive care unit who are approaching their first blood transfusion. Babies with major bowel abnormalities or a previous episode of NEC are not eligible. Finding a safe answer to this question could have a meaningful impact on the health of thousands of premature babies born every year.

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Interventions

Comparative effectiveness superiority trial of two clinical care pathways. As both comparator pathways of care are in standard use in Australia, there is no experimental arm. PATHWAY 1 – WITHHOLDING FEEDS AROUND TRANSFUSION Within the withholding feeds around transfusion pathway of care, all enteral feeds will be discontinued (the infant will be placed nil by mouth) for a period of 4 hours prior to packed red cell transfusion, during the packed red cell transfusion and until 4 hours post packed red cell transfusion. The bedside nurse will be responsible for adhering to the pathway and assessment of fidelity to the intervention will be by audit of bedside nursing notes.

Locations(6)

Royal Hospital for Women - Randwick

NSW,VIC, Australia

John Hunter Children's Hospital - New Lambton

NSW,VIC, Australia

Royal Prince Alfred Hospital - Camperdown

NSW,VIC, Australia

Liverpool Hospital - Liverpool

NSW,VIC, Australia

Mercy Hospital for Women - Heidelberg

NSW,VIC, Australia

Monash Children’s Hospital - Clayton

NSW,VIC, Australia

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