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NCT06067321
Gastric Residual Volumes in Infants Fed at 4 and 6 Hours Prior to General Anaesthesia
NA trial testing abdominal ultrasound, insertion of naso-gastric tube in Fasting in 70 participants. Status unknown.
1 May 2025
Quick facts
| Lead sponsor | King's College Hospital NHS Trust |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 70 |
| Start date | 1 May 2024 |
| Primary completion | 1 May 2025 |
| Estimated completion | 1 July 2025 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- abdominal ultrasound, insertion of naso-gastric tube
Conditions studied
- Fasting — all drugs for Fasting →
- Anesthesia — all drugs for Anesthesia →
- Pediatric ALL — all drugs for Pediatric ALL →
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.
Verify or expand the search:
- PubMed search for NCT06067321
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Other King's College Hospital NHS Trust trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06067321 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by King's College Hospital NHS Trust
- Last refreshed: 4 October 2023
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing