Necrotizing enterocolitis Neonatal Diseases Necrotizing enterocolitis of fetus and newborn
Conditions
Interventions
DESIGN: A multicentre, randomised, controlled, unblinded, pragmatic, pilot trial embedded within an electronic patient record system (point of care trial), comparing two parallel care pathways. Centra
stratification by site, minimisation by sex, gestational age
comparator arms:
1. WITHHOLD FEEDS AROUND TRANSFUSION: All enteral feeds will be discontinued (the infant will be placed nil by mouth) for a period of 4 hours prior to the transfusion, during the tra
Sponsors
Imperial College London & Imperial College Healthcare NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gestational age at birth <30 weeks (up to and including 29+6 weeks) 2. Babies will be recruited shortly after birth (and therefore before they are scheduled to have a blood transfusion in most cases). Blood transfusion is almost universal in babies of this gestational age (90-95% will need at least one blood transfusion prior to discharge) 3. Parents did not opt out of trial participation
Exclusion criteria
Exclusion criteria: 1. 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 still eligible) 2. Infants where enteral feeding is contraindicated in the first 7 days after birth (e.g. congenital abnormalities)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: To determine whether a point-of-care trial methodology (embedding trial processes and data collection within an existing electronic patient record system) is feasible for an individually randomised trial that includes preterm infants delivered at less than 30+0 gestational weeks+days, carried out in National Health Service neonatal units. These include: 1. Recruitment rate: Percentage of eligible cases where parents agree to trial involvement and the infant is randomised 2. Opt-out rate: Percentage of eligible cases where parents opted out of their infant being involved in the trial 3. Retention rate: Percentage of recruited infants who complete follow-up 4. Compliance: Percentage of cases where the allocated care pathway was adhered to 5. Data completeness: Percentage of recruited infants where trial data items are complete 6. Data accuracy: Percentage of recruited infants where data items are correctly recorded when compared to source data Outcomes will be measured up to and including 40+0 gestational weeks+days or neonatal unit discharge (if sooner) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary (clinical) outcomes: To determine if withholding enteral feeds around blood transfusion is superior to continued enteral feeding, in reducing incidence of NEC and other clinical outcomes before discharge from neonatal care. These include: 1. Necrotising enterocolitis: Histologically or surgically confirmed, or recorded in part 1 of the death certificate 2. Spontaneous intestinal perforation: Histologically or surgically confirmed, or recorded in part 1 of the death certificate 3. All-cause mortality 4. Length of neonatal unit stay: in days and including all levels of care 5. Duration of any parenteral nutrition: in days 6. Number of days with a central venous line in situ 7. Number of central line associated bloodstream infections: defined according to National Neonatal Audit Programme criteria (https://www.rcpch.ac.uk/work-we-do/quality-improvement-patient-safety/national-neonatal-audit-programme-nnap) 8. Growth: change in weight and head circumference for gestational age standard deviation score between birth and final neonatal discharge Outcomes will be measured up to and including 40+0 gestational weeks+days or neonatal unit discharge (if sooner) | — |
Countries
England, United Kingdom
Outcome results
None listed