Reducing Fasting Time for Breast Milk to 3 Hours

• Sponsor: King's College Hospital NHS Trust (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05355428
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 17
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The detrimental effects of prolonged fasting in young children prior to general anaesthesia are well known. Gastric emptying of breast milk and formula preparations has been extensively studied in neonatal intensive care for preterm and low birth weight infants, in order to establish optimum feeding regimens for growth.

Breast milk is known to empty from the stomach in a biphasic pattern (Cavell), reflecting rapid gastric emptying of foremilk, and the longer gastric residual time of the fatty, more calorie dense hind milk.

Studies of gastric emptying using Ultrasound (USS) in preterm babies suggest that gastric antral area returns to baseline within 3 hours of a having breast milk.

Methodologies utilised in such studies can make applying findings to 'everyday' 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 anaesthesia with a drug known to delay gastric emptying (atropine). There is a paucity of evidence in breast fed, un-premedicated term babies/infants subjected to a 3 hour fast prior to anaesthesia.

The aim of this study is to ascertain the gastric residual volume (GRV) in 35 infants who are given breast milk 3 hours prior to general anaesthesia. The secondary aim of this study is to ascertain how well ultrasound derived measurement of GRV correlates to direct measurement via nasogastric or orogastric aspiration.

Condition or Disease	Intervention/Treatment	Phase
Gastric Residual Volume	Other: Nasogastric tube	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Case seriesCase series
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Reducing Fasting Time for Breast Milk to 3 Hours
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 35 Term infants Series of 35 term infants	Other: Nasogastric tube; Aspirate gastric content and check gastric content PH

Outcome Measures

Primary Outcome Measures

1. Gastric residual volume [12 months]

   Ascertain the residual volume of gastric contents in 35 infants who are given breast milk 3 hours prior to general anaesthesia

Secondary Outcome Measures

1. Gastric ultrasound [12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Days to 12 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Term Infant, Elective surgery, first patient on the operation list, only breast milk fed including expressed breast milk.

Exclusion Criteria:

• Infants born prior to 36 weeks, or those with lung, heart and liver disease.

• Infants who are prescribed regular antacid medication.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King's College Hospital	London	Greater London	United Kingdom	SE5 9RS

Sponsors and Collaborators

• King's College Hospital NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

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.

• Responsible Party: King's College Hospital NHS Trust
• ClinicalTrials.gov Identifier: NCT05355428
• Other Study ID Numbers: 314367
• First Posted: May 2, 2022
• Last Update Posted: May 2, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by King's College Hospital NHS Trust: Term infant; Gastric residual volume; Breast milk; General anaesthetics

Study Results

No Results Posted as of May 2, 2022