The neoGASTRIC trial: Avoiding routine gastric residual volume measurement in neonatal critical care
| ISRCTN | ISRCTN16710849 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16710849 |
| IRAS number | 321050 |
| Secondary identifying numbers | IRAS 321050, CPMS 54912 |
- Submission date
- 25/01/2023
- Registration date
- 08/02/2023
- Last edited
- 08/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Neonatal Diseases
Plain English Summary
Background and study aims
About one in seven babies born in the UK each year need specialist neonatal care in a hospital because they are born too early, are born very small or have a medical condition. Ensuring these babies have enough nutrition is a key part of their care.
Premature babies are fed milk every few hours through a soft plastic tube via their nose or mouth into their stomach, called a gastric tube. As premature babies stomachs and digestive systems are not yet ready for lots of milk, the amount of milk given each feed is increased slowly. Some doctors and nurses regularly check how much milk is left in a baby's stomach, called 'routinely measuring gastric residual volumes'. They check because they believe it will help them know how the baby is coping with the milk feeds and they also think it may help to identify a severe disease called necrotising enterocolitis (NEC). However, others think that measuring gastric volumes may be bad for babies and that it is inaccurate, uncomfortable for the baby and may actually be harmful.
The aim of the neoGASTRIC trial is to see if premature babies can safely get to full milk feeds quicker.
Who can participate?
All babies that are born 6 or more weeks early (before 34 weeks of pregnancy) who require tube feeding. The neoGASTRIC study is an opt-out study. Therefore all eligible babies will take part unless a parent does not wish their baby to participate or there is a medical reason why.
What does the study involve?
The neoGASTRIC trial will involve babies born more than 6 weeks early and will recruit about 7000 premature babies across the UK and Australia. Babies will be recruited from about 36 hospitals in the UK and 3-4 large hospitals in Australia, and will be recruited into one of two groups: to have no routine gastric residual volumes measured, or have gastric residual volumes measured regularly. This will be decided by chance, and babies will have an equal chance of being in either group. The two approaches being compared are already used in clinical practice across the UK and Australia, so there is nothing new about either type of care. Babies will stay in the study until they reach full feeds, get discharged home, or when they reach 4 weeks past their due date (whichever one comes first)
The NeoGASTRIC trial will use an opt-out consent process, designed to be as simple as possible for families. This means that babies meeting the eligibility criteria will be automatically included in the trial unless parents opt-out. Parents will be informed about neoGASTRIC through posters and leaflets on the neonatal units and will have the option to opt-out at any point. This will make it easier for parents to be involved in the research and involve families who might not normally take part in research.
What are the possible benefits and risks of participating?
Both clinical approaches being studied are currently routinely practiced in the UK and Australia and so we do not believe there are any additional risks or benefits of taking part in neoGASTRIC. Not routinely measuring gastric residual volumes might lead to babies reaching full feeds quicker which might reduce the risk of infections – but we will only know this after we finish the neoGASTRIC study. We do not think there will be a greater risk of necrotising enterocolitis (NEC) from not routinely measuring gastric residual volumes because countries which do not routinely do this, such as France, have similar amounts of necrotising enterocolitis in the UK. Doctors and nurses will continue to look for necrotising enterocolitis through standard care and regular checks.
Where is the study run from?
The National Perinatal Epidemiology Unit, Clinical Trials Unit (NPEU CTU) at the University of Oxford, England, UK, in partnership with Monash University, Australia are coordinating and managing the study on behalf of the sponsor, Imperial College London.
When is the study starting and how long is it expected to run for?
September 2022 to October 2026
Who is funding the study?
The study is funded by the National Institute for Health and Care Research in the UK and the National Health and Medical Research Council in Australia.
Who is the main contact?
Chris Gale, Chief Investigator, Christopher.gale@imperial.ac.uk
Elizabeth Nuthall, Trial Manager, neogastric@npeu.ox.ac.uk
Contact information
Public
National Perinatal Epidemiology Unit (NPEU)
Nuffield Department of Population Health
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom
 ORCID ID |
0000-0002-5092-7643 |
|---|---|
| Phone | +44 1865 617927 |
| neogastric@npeu.ox.ac.uk |
Principal Investigator
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
| ORCID ID |
0000-0003-0707-876X |
|---|---|
| Phone | +44 (0)20 3315 3519 |
| christopher.gale@imperial.ac.uk |
Scientific
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
| Phone | +44 (0)20 3315 3519 |
|---|---|
| christopher.gale@imperial.ac.uk |
Study information
| Study design | Multi-centre randomized controlled trial |
|---|---|
| Primary study design | Other |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | https://www.npeu.ox.ac.uk/neogastric/parents/parent-information-sheet |
| Scientific title | 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)? |
| Study acronym | neoGASTRIC |
| Study hypothesis | The neoGASTRIC trial is taking place to determine whether avoiding the routine measurement of gastric residual volumes in preterm infants less than 34 weeks' gestation reduces the time taken for an infant to reach full enteral feeds without increasing harm, up until discharge home or 44+0 gestational weeks +days. |
| Ethics approval(s) |
Approved 08/02/2023, London Riverside Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8150; riverside.rec@hra.nhs.uk), ref: 23/LO/0060 |
| Condition | Preterm birth |
| Intervention | 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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 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. Non-inferiority outcome: 1. Necrotising enterocolitis (NEC), modified Bell's stage 2 or greater, evaluated by blinded endpoint review committee. Other secondary outcomes - Superiority outcomes 2. Severe NEC, confirmed at surgery or leading to death 3. All-cause mortality 4. Focal intestinal perforation 5. Gastrointestinal surgery 6. 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) 7. Duration of neonatal unit stay 8. Duration of any parenteral nutrition 9. Duration with a central venous line in situ 10. Weight standard deviation score 11. Head circumference standard deviation score 12. 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. _____ Original secondary outcome measures: 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. Non-inferiority outcome: 1. Necrotising enterocolitis (NEC), modified Bell's stage 2 or greater, evaluated by blinded endpoint review committee. Other secondary outcomes - Superiority outcomes 2. Severe NEC, confirmed at surgery or leading to death 3. All-cause mortality 4. Focal intestinal perforation 5. Gastrointestinal surgery 6. 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) 7. Duration of neonatal unit stay 8. Duration of any parenteral nutrition 9. Duration with a central venous line in situ 10. Weight standard deviation score 11. Head circumference standard deviation score 12. Duration of invasive ventilation 12. Chronic lung disease 13. Retinopathy of prematurity treated medically or surgically 14. Any vomiting resulting in feeds being withheld, measured up to 14 days from randomisation 15. Number of days feeds withheld at least once, measured up to 14 days from randomisation 16. Total number of hours feeds withheld, measured up to 14 days from randomisation 17. Breastfeeding at discharge home or 44+0 gestational weeks+days (whichever is sooner) 18. 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. |
| Overall study start date | 01/09/2022 |
| Overall study end date | 31/10/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 7040 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/04/2023 |
| Recruitment end date | 31/03/2026 |
Locations
Countries of recruitment
- Australia
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
369 Fulham Road
London
SW10 9NH
United Kingdom
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
A Floor - Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Treliske
Truro
TR1 3LJ
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Windmill Road
Gillingham
ME7 5NY
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Crown Street
Liverpool
L8 7SS
United Kingdom
London
SE11 4TX
United Kingdom
Uxbridge
UB8 3NN
United Kingdom
Praed Street
London
W2 1NY
United Kingdom
Luton
LU4 0DZ
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Holdforth Road
Hartlepool
TS24 9AH
United Kingdom
Seaway Parade Industrial Estate
Baglan
Port Talbot
SA12 7BR
United Kingdom
Marlborough Road
Swindon
SN3 6BB
United Kingdom
Shrewsbury
SY3 8XQ
United Kingdom
Watford General Hospital
Vicarage Road
Watford
WD18 0HB
United Kingdom
Clayton
Victoria
Clayton
3168
Australia
Parkville
Victoria
Melbourne
3052
Australia
50 Missenden Road
Camperdown
NSW
Sydney
2050
Australia
72 King William Road
North Adelaide
South Australia
North Adelaide
5006
Australia
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
St Davids Parc
Job's Well Road
Carmarthen
SA31 3BB
United Kingdom
Lodge Road
Caerleon
Newport
NP18 3XQ
United Kingdom
Ynysmeurig House
Navigation Park, Abercynon
Mountain Ash
CF45 4SN
United Kingdom
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
Derriford Road
Derriford
Plymouth
PL6 8DH
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Newton Road
Torquay
TQ2 7AA
United Kingdom
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
London
E9 6SR
United Kingdom
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
Scartho Road
Grimsby
DN33 2BA
United Kingdom
Watford Road
Harrow
HA1 3UJ
United Kingdom
Sharoe Green Lane
Fulwood
Preston
PR2 9HT
United Kingdom
Magdala Avenue
London
N19 5NF
United Kingdom
Sponsor information
University/education
South Kensington Campus
London
SW7 2AZ
England
United Kingdom
| Phone | +44 (0)20 7589 5111 |
|---|---|
| rgit@imperial.ac.uk | |
| Website | http://www.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 30/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publications in high-impact peer-reviewed journals, including publishing an account of the research project in the NIHR Journals Library. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 02/12/2022 | 05/04/2023 | No | No |
| HRA research summary | 20/09/2023 | No | No | ||
| Protocol file | version 3.0 | 19/04/2024 | 08/01/2025 | No | No |
Additional files
Editorial Notes
08/01/2025: The following changes were made to the study record:
1. Protocol uploaded.
2. Ethics approval details, interventions, primary and secondary outcome measures, inclusion and exclusion criteria were updated.
3. Scotland was added to the countries of recruitment.
4. The study participating centres were updated to remove London North West University Healthcare NHS Trust - Northwick Park Hospital - Oxford Covid19 Trials and add Northern Lincolnshire and Goole NHS Foundation Trust, London North West University Healthcare NHS Trust, Lancashire Teaching Hospitals NHS Foundation Trust and Whittington Health NHS Trust.
20/09/2023: A link to the HRA research summary was added.
13/06/2023: The following changes were made to the trial record:
1. The secondary outcome measures were changed.
2. The exclusion criteria were changed.
3. The participant information sheet was added.
4. The study participating centres Betsi Cadwaladr University Lhb, Hywel Dda Health Board, Aneurin Bevan University Lhb, Cwm Taf University Health Board, Cardiff & Vale University Lhb, University Hospitals Plymouth NHS Trust, Royal Devon University Healthcare NHS Foundation Trust, North Bristol NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Torbay and South Devon NHS Foundation Trust, Wirral University Teaching Hospital NHS Foundation Trust, Homerton Healthcare NHS Foundation Trust, North West Anglia NHS Foundation Trust, Maidstone and Tunbridge Wells NHS Trust, Bolton NHS Foundation Trust, Royal Prince Alfred Hospital, The Women's and Children's Hospital.
05/04/2023: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The trial participating centre St George's University Hospitals NHS Foundation Trust was added.
04/04/2023: The ethics approval was added.
30/01/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
