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

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.

Study Overview

• Status: Completed
• Conditions: Perioperative Complication
• Intervention / Treatment: Other: 3 hours of preoperative fasting for breast milk; Other: 4 hours of preoperative fasting for breast milk

Detailed Description

Since the publication of several studies indicating that many children are subjected to unnecessarily long fasting waiting for surgery, there is great interest within the pediatric anesthesia community to understand gastric emptying to be able to revise existing guidelines. The new recommendation from ESAIC is that 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 task force plans to perform a multicenter RCT comparing 4 vs 3 hours of preoperative fasting for breast milk.

Twenty infants scheduled for elective surgery or procedures requiring general anesthesia or sedation will be recruited for this randomized controlled pilot study.

Based on the randomization, they are then asked to breast-feed (or bottle-feed with breast-milk) the child at 4 or 3 hours before the scheduled anesthesia induction.

On arrival to the operating room, the gastric ultrasound examination will be performed for analysis of the gastric antrum CSA. After i.v. or inhalational anesthesia, an oro-gastric catheter will be inserted and any residual gastric contents are aspirated when rotating the infant from supine to semi-prone right and left positions. The volume and color of the aspirate will be recorded.

The aim of the present pilot-study is to provide data for sample size calculation and feasibility for the multicenter trial.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Breast-feeding infanta scheduled for elective procedure requiring general anesthesia

Exclusion Criteria:

• infant that does not breast-feed or is bottle-fed breast-milk
• Moderate to severe gastrointestinal motility disorder.
• Emergency surgery.
• Age > 24 months or age < 37 gestational weeks
• parents incapable of understanding the consent information due to language barrier

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3h Group; the patient's parents are instructed to stop feeding 3 hours for scheduled anesthesia. (3 hours of preoperative fasting for breast milk)	Other: 3 hours of preoperative fasting for breast milk; 3 hours of preoperative fasting for breast milk
Active Comparator: 4h Group; the patient's parents are instructed to stop feeding 4 hours for scheduled anesthesia (4 hours of preoperative fasting for breast milk)	Other: 4 hours of preoperative fasting for breast milk; 4 hours of preoperative fasting for breast milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSA	Gastric antrum CSA (The antral cross-sectional area)	From arrival in the operating room until induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aspirated volume	Aspirated volume	intraoperative

Collaborators and Investigators

• Sponsor: Uppsala University Hospital
• Investigators: Principal Investigator: Peter Frykholm, MD, PhD, Uppsala University Hospital

Publications and helpful links

Helpful Links

• Pre-operative fasting in children: A guideline from the European Society of Anaesthesiology and Intensive Care
• Gastric content assessed with gastric ultrasound in paediatric patients prescribed a light breakfast prior to general anaesthesia: A prospective observational study
• Ultrasound assessment of gastric emptying time after intake of clear fluids in children scheduled for general anesthesia-A prospective observational study

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Actual): February 5, 2024
• Study Completion (Actual): February 5, 2024

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Children; Anaesthesia; breast-feeding; Preoperative fasting
• Other Study ID Numbers: BMRCT PILOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No