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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05355428
Other study ID # 314367
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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


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Study Design


Related Conditions & MeSH terms


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)

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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
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