Gastric Residual VolumeNCT05355428
Reducing Fasting Time for Breast Milk to 3 Hours
An observational study of Gastric Residual Volume, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Shortening fasting times in young children undergoing general anesthesia aims to avoid the detrimental effects of prolonged fasting. However, the quantities of acidified milk that might be expected in the stomach following a shortened fast have not yet been fully investigated. Read more about this study
- Who is it for?
- Ages 0 to 18 months
- Conditions the study is for
- Gastric Residual Volume
- What is being tested?
- offering of breast milk feed 3 hours prior to planned surgery start
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: Breast fed children under 18 months of age, presenting for elective procedures under general anaesthesia
Who may be able to join
- Babies born at or after 37 weeks post menstrual age
- Babies born prior to 37 weeks who are now more than 37 weeks corrected post menstrual age (PMA)
- Elective surgery
- Breast fed including expressed breast milk, in isolation or combination with solids or formula.
Who cannot join
- Babies who are less than 37 weeks PMA,
- Ex-premature babies who are now greater than 37 weeks PMA but who have significant lung, heart, kidney or liver disease.
- Known delayed gastric emptying
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysing Gastric Residual Volumes in Infants Fed With Breast Milk 3 Hours Prior to General Anaesthesia
Shortening fasting times in young children undergoing general anesthesia aims to avoid the detrimental effects of prolonged fasting. However, the quantities of acidified milk that might be expected in the stomach following a shortened fast have not yet been fully investigated. The role of gastric ultrasound in quantifying particulate gastric content is not fully understood.
Read the detailed description
Prolonged fasting prior to general anaesthesia (GA) is common in children. It is associated with dehydration, hypoglycemia, and ketoacidosis in up to 28 % of children under 3 years, as well as distress in children and their families.
The purpose of pre-operative fasting is to reduce the volume, acidity, and particulate nature of any gastric contents; therefore, if an aspiration event occurs, lung damage will be minimal. Although pulmonary aspiration events are rare in children, data from animal models suggest that the volume, and presence of particulate matter, such as that seen in acidified breast or formula milk, can affect the patterns of lung damage. Aspiration of volumes greater than 0.8 ml.kg-1 appear to be the most harmful in animal models, regardless of pH.
In humans, gastric emptying of breast and formula milk preparations has been extensively studied in the neonatal setting in preterm and low-birth-weight infants. The majority used serial measurements of antral cross-sectional area (ACSA) with gastric ultrasound (US) and reported the return of ACSA values to baseline within 3 h for breast milk and 4 h for formula milk.
The European Society of Anesthesia and Intensive Care published guidance in 2022, advocating a 3-hour breast milk fast, and a 4-hour formula milk fast in children under 1 year undergoing elective GA. This guidance has been adopted in some tertiary centers in the UK despite the paucity of prospective studies investigating the impact of a shortened fast on gastric residual volume (GRV) measured directly (for example, by gastric aspiration).
In 2011, using data from adult elective surgical patients, Perlas et al. devised a qualitative assessment grading system to assess the gastric antrum prior to induction [15], with a view to guiding decision making regarding the induction method. various formulae that incorporate antrum grade and antrum cross sectional area have subsequently been devised and validated in adults and children over 1 year of age.
A formula devised by Kim et al. demonstrated good correlation with suctioned gastric volumes in anesthetized children under 1 year of age. It is not known whether a formula derived from data in a cohort of children with clear fluid gastric content resulting from a prolonged overnight fast will perform as well in a cohort of young children who have recently been fed, where, if present, gastric content may be semi-solid or particulate.
The primary aims of this study were to measure GRV of gastric contents measured by naso-gastric aspiration in infants who were breast fed 3 hours prior to general anesthesia. The secondary aim is to correlate predicted GRV using a mathematical formula proposed by Kim et al, to measure GRV by NG aspiration.
- Conditions
- Gastric Residual Volume
- Being tested
- offering of breast milk feed 3 hours prior to planned surgery start
- Keywords
- anaesthesia, ultrasound, Breast milk, fasting, gastric
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
offering of breast milk feed 3 hours prior to planned surgery startOther
parents will be asked to offer a breast milk feed (from breast or expressed in bottle) at a given time 3 hours prior to planned induction time
| Study group | Role | What they receive |
|---|---|---|
| recruited patients | recruited patients will be required to feed 3 hours prior to planned procedure start with their normal method of taking breast milk (from the breast, or expressed into a bottle). Receives: Other: offering of breast milk feed 3 hours prior to planned surgery start |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric residual volume
Ascertain the residual volume of gastric contents in 50 infants who are given breast milk 3 hours prior to general anaesthesia
Measured: 12 months
Secondary outcomes (1)
Gastric ultrasound
The secondary aim of this study is to ascertain how well ultrasound derived measurement of gastric residual volume correlates to direct measurement via nasogastric tube aspiration.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Sep 2022
- Primary completion1 Aug 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Gastric Residual VolumeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355428
- Sponsor's protocol ID
- 314367
- Status last verified
- Aug 2024
- First submitted
- 22 Mar 2022
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On reasonable request data can be supplied
Publications
Perrella SL, Hepworth AR, Gridneva Z, Simmer KN, Hartmann PE, Geddes DT. Gastric Emptying and Curding of Pasteurized Donor Human Milk and Mother's Own Milk in Preterm Infants. J Pediatr Gastroenterol Nutr. 2015 Jul;61(1):125-9. doi: 10.1097/MPG.0000000000000776.
PubMed 25729886Litman RS, Wu CL, Quinlivan JK. Gastric volume and pH in infants fed clear liquids and breast milk prior to surgery. Anesth Analg. 1994 Sep;79(3):482-5. doi: 10.1213/00000539-199409000-00013.
PubMed 8067551van der Walt JH, Foate JA, Murrell D, Jacob R, Bentley M. A study of preoperative fasting in infants aged less than three months. Anaesth Intensive Care. 1990 Nov;18(4):527-31. doi: 10.1177/0310057X9001800420.
PubMed 2268020Walker RW. Pulmonary aspiration in pediatric anesthetic practice in the UK: a prospective survey of specialist pediatric centers over a one-year period. Paediatr Anaesth. 2013 Aug;23(8):702-11. doi: 10.1111/pan.12207. Epub 2013 Jun 13.
PubMed 23763657Warner MA, Warner ME, Warner DO, Warner LO, Warner EJ. Perioperative pulmonary aspiration in infants and children. Anesthesiology. 1999 Jan;90(1):66-71. doi: 10.1097/00000542-199901000-00011.
PubMed 9915314Tan Z, Lee SY. Pulmonary aspiration under GA: a 13-year audit in a tertiary pediatric unit. Paediatr Anaesth. 2016 May;26(5):547-52. doi: 10.1111/pan.12877. Epub 2016 Mar 17.
PubMed 26990683Ewer AK, Yu VY. Gastric emptying in pre-term infants: the effect of breast milk fortifier. Acta Paediatr. 1996 Sep;85(9):1112-5. doi: 10.1111/j.1651-2227.1996.tb14227.x.
PubMed 8888928MASON S. Some aspects of gastric function in the newborn. Arch Dis Child. 1962 Aug;37(194):387-91. doi: 10.1136/adc.37.194.387. No abstract available.
PubMed 14470855Van Den Driessche M, Peeters K, Marien P, Ghoos Y, Devlieger H, Veereman-Wauters G. Gastric emptying in formula-fed and breast-fed infants measured with the 13C-octanoic acid breath test. J Pediatr Gastroenterol Nutr. 1999 Jul;29(1):46-51. doi: 10.1097/00005176-199907000-00013.
PubMed 10400103Cavell B. Gastric emptying in infants fed human milk or infant formula. Acta Paediatr Scand. 1981 Sep;70(5):639-41.
PubMed 7324911Beck CE, Witt L, Albrecht L, Winstroth AM, Lange M, Dennhardt N, Boethig D, Sumpelmann R. Ultrasound assessment of gastric emptying time in preterm infants: A prospective observational study. Eur J Anaesthesiol. 2019 Jun;36(6):406-410. doi: 10.1097/EJA.0000000000001007.
PubMed 31021881Italianer MF, Naninck EFG, Roelants JA, van der Horst GTJ, Reiss IKM, Goudoever JBV, Joosten KFM, Chaves I, Vermeulen MJ. Circadian Variation in Human Milk Composition, a Systematic Review. Nutrients. 2020 Aug 4;12(8):2328. doi: 10.3390/nu12082328.
PubMed 32759654Kent JC, Mitoulas LR, Cregan MD, Ramsay DT, Doherty DA, Hartmann PE. Volume and frequency of breastfeedings and fat content of breast milk throughout the day. Pediatrics. 2006 Mar;117(3):e387-95. doi: 10.1542/peds.2005-1417.
PubMed 16510619Janahi IA, Elidemir O, Shardonofsky FR, Abu-Hassan MN, Fan LL, Larsen GL, Blackburn MR, Colasurdo GN. Recurrent milk aspiration produces changes in airway mechanics, lung eosinophilia, and goblet cell hyperplasia in a murine model. Pediatr Res. 2000 Dec;48(6):776-81. doi: 10.1203/00006450-200012000-00013.
PubMed 11102546O'Hare B, Chin C, Lerman J, Endo J. Acute lung injury after instillation of human breast milk into rabbits' lungs: effects of pH and gastric juice. Anesthesiology. 1999 Apr;90(4):1112-8. doi: 10.1097/00000542-199904000-00026.
PubMed 10201684
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysing Gastric Residual Volumes in Infants Fed With Breast Milk 3 Hours Prior to General Anaesthesia
- ClinicalTrials.gov ID
- NCT05355428
- Acronym / sponsor ID
- 314367
- Conditions
- Gastric Residual Volume
- Keywords
- anaesthesia, ultrasound, Breast milk, fasting, gastric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shortening fasting times in young children undergoing general anesthesia aims to avoid the detrimental effects of prolonged fasting. However, the quantities of acidified milk that might be expected in the stomach following a shortened fast have not yet been fully investigated. The role of gastric ultrasound in quantifying particulate gastric content is not fully understood.
Detailed description
Prolonged fasting prior to general anaesthesia (GA) is common in children. It is associated with dehydration, hypoglycemia, and ketoacidosis in up to 28 % of children under 3 years, as well as distress in children and their families.
The purpose of pre-operative fasting is to reduce the volume, acidity, and particulate nature of any gastric contents; therefore, if an aspiration event occurs, lung damage will be minimal. Although pulmonary aspiration events are rare in children, data from animal models suggest that the volume, and presence of particulate matter, such as that seen in acidified breast or formula milk, can affect the patterns of lung damage. Aspiration of volumes greater than 0.8 ml.kg-1 appear to be the most harmful in animal models, regardless of pH.
In humans, gastric emptying of breast and formula milk preparations has been extensively studied in the neonatal setting in preterm and low-birth-weight infants. The majority used serial measurements of antral cross-sectional area (ACSA) with gastric ultrasound (US) and reported the return of ACSA values to baseline within 3 h for breast milk and 4 h for formula milk.
The European Society of Anesthesia and Intensive Care published guidance in 2022, advocating a 3-hour breast milk fast, and a 4-hour formula milk fast in children under 1 year undergoing elective GA. This guidance has been adopted in some tertiary centers in the UK despite the paucity of prospective studies investigating the impact of a shortened fast on gastric residual volume (GRV) measured directly (for example, by gastric aspiration).
In 2011, using data from adult elective surgical patients, Perlas et al. devised a qualitative assessment grading system to assess the gastric antrum prior to induction [15], with a view to guiding decision making regarding the induction method. various formulae that incorporate antrum grade and antrum cross sectional area have subsequently been devised and validated in adults and children over 1 year of age.
A formula devised by Kim et al. demonstrated good correlation with suctioned gastric volumes in anesthetized children under 1 year of age. It is not known whether a formula derived from data in a cohort of children with clear fluid gastric content resulting from a prolonged overnight fast will perform as well in a cohort of young children who have recently been fed, where, if present, gastric content may be semi-solid or particulate.
The primary aims of this study were to measure GRV of gastric contents measured by naso-gastric aspiration in infants who were breast fed 3 hours prior to general anesthesia. The secondary aim is to correlate predicted GRV using a mathematical formula proposed by Kim et al, to measure GRV by NG aspiration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| recruited patients | – | Other: offering of breast milk feed 3 hours prior to planned surgery startrecruited patients will be required to feed 3 hours prior to planned procedure start with their normal method of taking breast milk (from the breast, or expressed into a bottle). |
Who may qualify
- Ages
- 0 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Breast fed children under 18 months of age, presenting for elective procedures under general anaesthesia
Key inclusion criteria (4 listed)
- Babies born at or after 37 weeks post menstrual age
- Babies born prior to 37 weeks who are now more than 37 weeks corrected post menstrual age (PMA)
- Elective surgery
- Breast fed including expressed breast milk, in isolation or combination with solids or formula.
Key exclusion criteria (3 listed)
- Babies who are less than 37 weeks PMA,
- Ex-premature babies who are now greater than 37 weeks PMA but who have significant lung, heart, kidney or liver disease.
- Known delayed gastric emptying
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| offering of breast milk feed 3 hours prior to planned surgery startparents will be asked to offer a breast milk feed (from breast or expressed in bottle) at a given time 3 hours prior to planned induction time | Other | recruited patients |
Primary outcome
Gastric residual volume
Time frame: 12 months
Ascertain the residual volume of gastric contents in 50 infants who are given breast milk 3 hours prior to general anaesthesia
1 secondary outcome
Gastric ultrasound
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Background: PubMed 25729886Perrella SL, Hepworth AR, Gridneva Z, Simmer KN, Hartmann PE, Geddes DT. Gastric Emptying and Curding of Pasteurized Donor Human Milk and Mother's Own Milk in Preterm Infants. J Pediatr Gastroenterol Nutr. 2015 Jul;61(1):125-9. doi: 10.1097/MPG.0000000000000776.
- Results publication: PubMed 8067551Litman RS, Wu CL, Quinlivan JK. Gastric volume and pH in infants fed clear liquids and breast milk prior to surgery. Anesth Analg. 1994 Sep;79(3):482-5. doi: 10.1213/00000539-199409000-00013.
- Results publication: PubMed 2268020van der Walt JH, Foate JA, Murrell D, Jacob R, Bentley M. A study of preoperative fasting in infants aged less than three months. Anaesth Intensive Care. 1990 Nov;18(4):527-31. doi: 10.1177/0310057X9001800420.
- Results publication: PubMed 23763657Walker RW. Pulmonary aspiration in pediatric anesthetic practice in the UK: a prospective survey of specialist pediatric centers over a one-year period. Paediatr Anaesth. 2013 Aug;23(8):702-11. doi: 10.1111/pan.12207. Epub 2013 Jun 13.
- Results publication: PubMed 9915314Warner MA, Warner ME, Warner DO, Warner LO, Warner EJ. Perioperative pulmonary aspiration in infants and children. Anesthesiology. 1999 Jan;90(1):66-71. doi: 10.1097/00000542-199901000-00011.
- Results publication: PubMed 26990683Tan Z, Lee SY. Pulmonary aspiration under GA: a 13-year audit in a tertiary pediatric unit. Paediatr Anaesth. 2016 May;26(5):547-52. doi: 10.1111/pan.12877. Epub 2016 Mar 17.
- Results publication: PubMed 8888928Ewer AK, Yu VY. Gastric emptying in pre-term infants: the effect of breast milk fortifier. Acta Paediatr. 1996 Sep;85(9):1112-5. doi: 10.1111/j.1651-2227.1996.tb14227.x.
- Results publication: PubMed 14470855MASON S. Some aspects of gastric function in the newborn. Arch Dis Child. 1962 Aug;37(194):387-91. doi: 10.1136/adc.37.194.387. No abstract available.
- Results publication: PubMed 10400103Van Den Driessche M, Peeters K, Marien P, Ghoos Y, Devlieger H, Veereman-Wauters G. Gastric emptying in formula-fed and breast-fed infants measured with the 13C-octanoic acid breath test. J Pediatr Gastroenterol Nutr. 1999 Jul;29(1):46-51. doi: 10.1097/00005176-199907000-00013.
- Results publication: PubMed 7324911Cavell B. Gastric emptying in infants fed human milk or infant formula. Acta Paediatr Scand. 1981 Sep;70(5):639-41.
- Results publication: PubMed 31021881Beck CE, Witt L, Albrecht L, Winstroth AM, Lange M, Dennhardt N, Boethig D, Sumpelmann R. Ultrasound assessment of gastric emptying time in preterm infants: A prospective observational study. Eur J Anaesthesiol. 2019 Jun;36(6):406-410. doi: 10.1097/EJA.0000000000001007.
- Results publication: PubMed 32759654Italianer MF, Naninck EFG, Roelants JA, van der Horst GTJ, Reiss IKM, Goudoever JBV, Joosten KFM, Chaves I, Vermeulen MJ. Circadian Variation in Human Milk Composition, a Systematic Review. Nutrients. 2020 Aug 4;12(8):2328. doi: 10.3390/nu12082328.
- Gastric Emptying and Intragastric Behavior of Breast Milk and Infant Formula in Lactating MothersLink provided by the sponsor.
- Individual participant dataSharing planned: No. On reasonable request data can be supplied
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Residual Volume, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric residual volume (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05355428, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.