Among babies born <34+0 gestational weeks does no routine measurement of gastric residual volume compared to routine (up to 6 hourly) measurement of gastric residual volumes lead to faster establishment of full enteral feeds without an increase in necrotising enterocolitis (NEC)?
Preterm birth
The neoGASTRIC study is an individually randomised, controlled, unmasked, trial comparing two parallel care pathways, with an internal pilot and process evaluation. The two care pathways to be compared are: 1. No routine measurement of gastric residual volumes 2. Routine, up to 6-hourly, measurements of gastric residual volumes. Both pathways represent standard clinical practice in different neonatal units in the UK and Australia. Eligible infants will be identified by the neonatal teams in both the UK and Australia after admission. As both care pathways are standard neonatal practice, neoGASTRIC will use an opt-out consent approach. The allocated pathway will be followed for as long as routine gastric residual measurement is standard local practice, until gastric feeding tubes are no longer required, the infant is discharged home or reaches 44+0 gestational weeks +days (whichever is sooner). Updated 08/01/2025: The allocated pathway will be followed for as long as routine gastric residual measurement is standard local practice, or until gastric feeding tubes are no longer required, or the infant is discharged home, or the infant reaches 44+0 gestational weeks +days Randomisation of infants to either no routine measurement of gastric residual volumes or up to 6 hourly measurement of gastric residual volumes will be managed via a secure web-based randomisation facility hosted by the National Perinatal Epidemiology Unit Clinical Trials Unit (University of Oxford) with telephone backup available at all times (365 days per year). Infants will be randomised using an online secure central randomisation service to ensure allocation concealment. The randomisation program will use a probabilistic minimisation algorithm and randomisation will use a 1:1 allocation ratio. To ensure balance between the randomised groups, minimisation criteria will include: hospital, multiple births and week of gestational age at birth.
Updated 08/01/2025: Corrected as of 03/04/2023: 1. Gestational age at birth less than 34+0 gestational weeks+days 2. Nasogastric or orogastric tube in place _____ Previous inclusion criteria: 1. Gestational age at birth less than 34+0 gestational weeks+days 2. Nasogastric or orogastric tube in place 3. Baby receiving less than or equal to 15 ml/kg/day of milk
Updated 08/01/2025: Current exclusion criteria as of 03/04/2023: 1. Infant has received more than 15ml/kg/day of milk for more than 24 hours 2. Gastrointestinal surgical condition (including suspected necrotising enterocolitis and focal intestinal perforation) prior to randomisation 3. Major congenital abnormalities 4. No realistic prospect of survival 5. A parent has opted out of infant's participation in neoGASTRIC _____ Previous exclusion criteria: 1. Infant has received more than 15ml/kg/day of milk for more than 24 hours 2. Gastrointestinal surgical condition prior to randomisation 3. Major congenital abnormalities 4. No realistic prospect of survival 5. A parent has opted out of infant’s participation in neoGASTRIC _____ Original exclusion criteria: 1. Gastrointestinal surgical condition prior to randomisation 2. Major congenital abnormalities 3. No realistic prospect of survival 4. A parent has opted out of infant’s participation in neoGASTRIC