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NCT06067321

Gastric Residual Volumes in Infants Fed at 4 and 6 Hours Prior to General Anaesthesia

Status unknown NA Last updated 4 October 2023
What this trial tests

NA trial testing abdominal ultrasound, insertion of naso-gastric tube in Fasting in 70 participants. Status unknown.

Timeline
1 May 2024
Primary endpoint
1 May 2025
1 July 2025

Quick facts

Lead sponsorKing's College Hospital NHS Trust
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment70
Start date1 May 2024
Primary completion1 May 2025
Estimated completion1 July 2025
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

King's College Hospital NHS Trust

Who can join

Under 1, any sex, with Fasting or Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The safety implications of prolonged fasting in young children prior to general anaesthesia are well described. Current UK guidance recommends a fasting time of 6 hours for formula milk prior to general anaesthesia. European guidance published in 2022 recommended a reduced fast of 4 hours for infants taking formula milk, albeit with a downgraded level 2B of evidence given the paucity of high quality research in this area. Although pulmonary aspiration of gastric contents under anaesthesia in children is a rare event, animal studies suggest that aspiration of particulate matter at volumes greater than 0.8 ml/kg gastric volume are associated with demonstrable lung injury and mortality. Although rate of gastric emptying of formula preparations has been extensively studied in neonatal intensive care settings for preterm babies using ultrasound, few studies have measured gastric volume directly in healthy term infants undergoing anaesthesia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Fasting

Currently open trials in the same condition.

Other King's College Hospital NHS Trust trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06067321.

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