Reducing Fasting Time for Breast Milk to 3 Hours

NCT05355428 | Completed

• 1 other identifier: 314367
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. The role of gastric ultrasound in quantifying particulate gastric content is not fully understood.

Conditions

Gastric Residual Volume

Keywords

anaesthesia; ultrasound; Breast milk; fasting; gastric

Outcome Measures

Primary Outcomes (1)

• Gastric residual volume

  Ascertain the residual volume of gastric contents in 50 infants who are given breast milk 3 hours prior to general anaesthesia

  12 months

Secondary Outcomes (1)

• Gastric ultrasound

  12 months

Study Arms (1)

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).

Other: offering of breast milk feed 3 hours prior to planned surgery start

Interventions

offering of breast milk feed 3 hours prior to planned surgery start OTHER

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

recruited patients

Eligibility Criteria

• Age: 0 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Breast fed children under 18 months of age, presenting for elective procedures under general anaesthesia

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

Emily Saffer

London, Greater London, SE5 9RS, United Kingdom

Location

Related Publications (16)

• 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.

  PMID: 25729886 BACKGROUND

• Litman 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.

  PMID: 8067551 RESULT

• van 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.

  PMID: 2268020 RESULT

• Walker 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.

  PMID: 23763657 RESULT

• Warner 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.

  PMID: 9915314 RESULT

• Tan 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.

  PMID: 26990683 RESULT

• Ewer 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.

  PMID: 8888928 RESULT

• MASON 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.

  PMID: 14470855 RESULT

• Van 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.

  PMID: 10400103 RESULT

• Cavell B. Gastric emptying in infants fed human milk or infant formula. Acta Paediatr Scand. 1981 Sep;70(5):639-41.

  PMID: 7324911 RESULT

• Beck 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.

  PMID: 31021881 RESULT

• Italianer 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.

  PMID: 32759654 RESULT

• Kent 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.

  PMID: 16510619 RESULT

• Janahi 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.

  PMID: 11102546 RESULT

• O'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.

  PMID: 10201684 RESULT

• Yigit S, Akgoz A, Memisoglu A, Akata D, Ziegler EE. Breast milk fortification: effect on gastric emptying. J Matern Fetal Neonatal Med. 2008 Nov;21(11):843-6. doi: 10.1080/14767050802287176.

  PMID: 18985557 RESULT

Related Links

• Gastric Emptying and Intragastric Behavior of Breast Milk and Infant Formula in Lactating Mothers

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: May 2, 2022
• Study Start: September 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 29, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)