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NCT05573165: BMRCT
A Pilot Study of the Effects of 4 vs 3 Hours of Preoperative Fasting in Breast-feeding Infants
NA trial testing 3 hours of preoperative fasting for breast milk in Perioperative Complication in 20 participants. Completed in 5 February 2024.
5 February 2024
Quick facts
| Lead sponsor | Uppsala University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 16 January 2023 |
| Primary completion | 5 February 2024 |
| Estimated completion | 5 February 2024 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- 3 hours of preoperative fasting for breast milk
- 4 hours of preoperative fasting for breast milk
Conditions studied
- Perioperative Complication — all drugs for Perioperative Complication →
Sponsor
Uppsala University Hospital
Who can join
Adults 0 to 24 Months, any sex, with Perioperative Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In the new guideline from ESAIC breast-feeding should be encouraged until 3 hours before anesthesia. This recommendation was based mainly on gastric emptying studies in neonates with small sample sizes and single center experience.To address the lack of high quality evidence for this recommendation, the ESAIC task force for preoperative fasting plans perform a multicenter RCT omparing 4 vs 3 hours of preoperative fasting for breast milk. The aim of the present pilot-study is to provide data for sample size calculation and feasibility for the multicenter trial.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Estimation of Residual Gastric Content After 3 or 4 h Fasting for Breast Milk in Infants: A Pilot Study With Randomization.
Morell S, Uslu A, Modiri AR, Andersson H, et al · · 2025 · PMID 40960264 · DOI 10.1111/pan.70053
Verify or expand the search:
- PubMed search for NCT05573165
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Uppsala University Hospital 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 NCT05573165 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Uppsala University Hospital
- Last refreshed: 22 March 2024
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/NCT05573165.
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