Clinical trial · Interventional
Gastric Residual Volumes in Infants Fed at 4 and 6 Hours Prior to General Anaesthesia
Comparison of Gastric Residual Volumes in Infants Fed at 4 and 6 Hours Prior to General Anaesthesia: A Randomised Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia | — | UNRESOLVED | — |
| Fasting | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| abdominal ultrasound, insertion of naso-gastric tube | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 4 hours formula feed
- description
- Parents asked to offer formula feed 4 hours prior to anticipated procedure start
- interventionNames
- Other: abdominal ultrasound, insertion of naso-gastric tube
- type
- ACTIVE_COMPARATOR
- label
- 6 hour formula feed
- description
- Parents asked to offer formula 6 hours prior to anticipated procedure start
- interventionNames
- Other: abdominal ultrasound, insertion of naso-gastric tube
Primary outcomes (1)
- measure
- gastric residual volume
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 1 Year
Show eligibility criteria text
Inclusion Criteria: Term or term corrected (\> 37 weeks) upto 12 months Formula fed ASA 1-3 Exclusion Criteria: Significant reflux Co-administration of drugs known to impact gastric motility or PH of gastric contents Significant respiratory comorbidity including chronic lung disease on home oxygen Significant cardiac comorbidity
References
Publications (0)
Data not yet available