Preterm birth Neonatal Diseases
Conditions
Interventions
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 compare
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Superiority outcome: All outcomes will be measured up to discharge home or when the infant reaches 44+0 gestational weeks, whichever is sooner, unless otherwise stated. All data will be collected from infants' hospital notes/records. 1. neoGASTRIC main trial - superiority outcome Time from birth to reach full milk feeds for 3 consecutive days (at least 145 ml/kg/day where this is considered full enteral feeds, or where breastfeeding and any additional milk is considered equivalent to full enteral feeds). Also including, 2. neoGASTRIC Process Evaluation primary outcome: to evaluate pilot phase trial processes by analysing parent and staff responses from questionnaires and observing staff practices. 3. neoGASTRIC SWAT primary outcome: the parent did not opt out of infant's participation in the trial pre-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Updated 08/01/2025: Secondary outcome measures as of 13/06/2023: All outcomes will be measured up to discharge home or when the infant reaches 44+0 gestational weeks, whichever is sooner, unless otherwise stated. All data will be collected from infants' hospital notes/records. Key secondary outcomes (non-inferiority outcome): Necrotising enterocolitis (NEC), modified Bell's stage 2 or greater, evaluated by blinded endpoint review committee. Other secondary outcomes (superiority outcomes): 1. Severe NEC, confirmed at surgery or leading to death 2. All-cause mortality 3. Focal intestinal perforation 4. Gastrointestinal surgery 5. Late-onset infection: microbiologically-confirmed or clinically suspected infection >72 hours after birth, evaluated by blinded endpoint review committee. To note: this is the same that has been used in previous trials (e.g. SIFT, ELFIN) 6. Duration of neonatal unit stay 7. Duration of any parenteral nutrition 8. Duration with a central venous line in situ 9. Weight standard deviation score 10. Head circumference standard deviation score 11. Duration of invasive ventilation 12. Chronic lung disease 13. Retinopathy of prematurity treated medically or surgically 14. Brain injury on imaging: intraventricular haemorrhage grade 3 or 4 and/or cystic periventricular leukomalacia 15. Any vomiting resulting in feeds being withheld, up to 14 days from randomisation 16. Number of days feeds withheld at least once, up to 14 days from randomisation 17. Total number of hours feeds withheld, up to 14 days from randomisation 18. Breastfeeding at discharge home or 44+0 gestational weeks+days (whichever is sooner) 19. Receiving maternal breastmilk at discharge home or 44+0 gestational weeks+days (whichever is sooner) neoGASTRIC SWAT secondary outcome is to evaluate the quality of parental decision making by using descriptive statistics. _____ Previous secondary outcome measures as of 13/06/2023: All outcomes will be measured up to discharge home o | — |
Countries
Australia, England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactElizabeth Nuthall
Outcome results
None listed