Reducing Fasting Time for Breast Milk to 3 Hours

Gastric Residual Volume Clinical Trial

Official title:

Reducing Fasting Time for Breast Milk to 3 Hours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05355428
• Other study ID #: 314367
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: August 2023
• Source: King's College Hospital NHS Trust
• Contact: Emily Saffer, Dr
• Phone: 07890549924
• Email: emily.saffer[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to ascertain Gastric residual volume (GRV) of gastric contents in 35 infants who are breast fed 3 hours prior to general anaesthesia. The secondary aim of this study is to ascertain how well ultrasound (USS) derived measurement of GRV, using the gastric antrum cross sectional area (ACSA), correlates to direct measurement via aspiration.

Description:

Current UK guidance recommends a fasting time of 4 hours for breast milk prior to general anaesthesia. Gastric emptying (GE) of breast milk and formula preparations has been extensively studied in neonatal intensive care settings for preterm and low birth weight infants, in order to establish optimum feeding regimens for growth. Methodologies utilised in such studies can make applying findings to current routine anaesthetic practice difficult: Such as inclusion of very low birth weight infants, use of fortified breast milk, administering feeds via nasogastric tube and pre-medication of children prior to GA with atropine. There is a paucity of evidence in breast fed, un-premedicated term babies/infants subjected to a 3 hour fast prior to GA. Pulmonary aspiration is known to be a rare event associated with lower morbidity and mortality in children than adults . In animal studies, instillation of acidified milk solutions into the lungs of anaesthetised rabbits is associated with increasing severity of lung injury as volume of solution increases above 0.8 ml/kg regardless of pH. Anaesthetising a child or adult with a full stomach is more hazardous and requires alteration of the anaesthetic technique to minimise risk of aspiration. Gastric ultrasound (USS) is a useful tool for assessing stomach volume prior to induction of anaesthesia. Various formulae have been devised to convert measured gastric antral area to volume in children. USS is validated in older children and adults in measurement of gastric ACSA and derived volume of gastric contents. We will perform a prospective, interventional study of 35 term infants aged 37 weeks to 18 months, undergoing elective surgery

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: February 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Months

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gastric Residual Volume

Intervention

Other:
• offering of breast milk feed 3 hours prior to p lanned surgery start
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

Locations

Country	Name	City	State
United Kingdom	Emily Saffer	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (16)

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.00 — View Citation

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

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. — View Citation

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. — View Citation

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;4 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: 10.1097/00 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric residual volume	Ascertain the residual volume of gastric contents in 35 infants who are given breast milk 3 hours prior to general anaesthesia	12 months
Secondary	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.	12 months

External Links

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