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OpenTrials
Completed

NCT Number: NCT05355428

Reducing Fasting Time for Breast Milk to 3 Hours

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.

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Key information

Age range

0 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Emily Saffer

London, Greater London, SE5 9RS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

Analysing Gastric Residual Volumes in Infants Fed With Breast Milk 3 Hours Prior to General Anaesthesia

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 2, 2022
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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