Reducing Fasting Time for Breast Milk to 3 Hours

June 25, 2025 updated by: King's College Hospital NHS Trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • Emily Saffer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric ultrasound
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 29, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 314367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

On reasonable request data can be supplied

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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