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

NCT05573165 | Completed

• 1 other identifier: BMRCT PILOT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preoperative fasting; Anaesthesia; Children; breast-feeding

Outcome Measures

Primary Outcomes (1)

• CSA

  Gastric antrum CSA (The antral cross-sectional area)

  From arrival in the operating room until induction of anesthesia

Secondary Outcomes (1)

• Aspirated volume

  intraoperative

Study Arms (2)

3h Group

EXPERIMENTAL

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

4h Group

ACTIVE COMPARATOR

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

Interventions

3 hours of preoperative fasting for breast milk OTHER

3 hours of preoperative fasting for breast milk

3h Group

4 hours of preoperative fasting for breast milk OTHER

4 hours of preoperative fasting for breast milk

4h Group

Eligibility Criteria

• Age: 0 Years - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related 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

MeSH Terms

Conditions

Breast Feeding

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Peter Frykholm, MD, PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Computerized randomization,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Prospective randomized controlled pilot study

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: October 10, 2022
• Study Start: January 16, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)