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NCT05573165: BMRCT

A Pilot Study of the Effects of 4 vs 3 Hours of Preoperative Fasting in Breast-feeding Infants

Completed NA Last updated 22 March 2024
What this trial tests

NA trial testing 3 hours of preoperative fasting for breast milk in Perioperative Complication in 20 participants. Completed in 5 February 2024.

Timeline
16 January 2023
Primary endpoint
5 February 2024
5 February 2024

Quick facts

Lead sponsorUppsala University Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment20
Start date16 January 2023
Primary completion5 February 2024
Estimated completion5 February 2024
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other recruiting trials for Perioperative Complication

Currently open trials in the same condition.

Other Uppsala University Hospital 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/NCT05573165.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing