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

NCT05573165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-03-22

No results posted yet for this study

Summary

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.

Conditions

  • Perioperative Complication

Interventions

OTHER

3 hours of preoperative fasting for breast milk

3 hours of preoperative fasting for breast milk

OTHER

4 hours of preoperative fasting for breast milk

4 hours of preoperative fasting for breast milk

Sponsors & Collaborators

  • Uppsala University Hospital

    lead OTHER

Principal Investigators

  • Peter Frykholm, MD, PhD · Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2024-02-05
Completion
2024-02-05

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05573165 on ClinicalTrials.gov