None listed
Conditions
Brief 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.
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
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.
Sponsors
Australian and New Zealand Neonatal Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 3 Months
Healthy volunteers
No
Inclusion criteria
1. Preterm birth at less than 30 weeks gestation 2. Parents do not opt out of trial participation
Exclusion criteria
1. Infants with major congenital malformation of the gastrointestinal tract 2. Parents have chosen to opt out from participation 3. Given packed red cell transfusion with concurrent enteral feeds before enrolment (infants who have received a packed red cell transfusion while nil by mouth ARE still eligible) 4. Previous episode of NEC
Outcome results
None listed