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NCT05573165 Clinical Trial

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

Perioperative Complication Clinical Trial

— BMRCT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05573165
Other study ID # BMRCT PILOT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 16, 2023
Est. completion date February 5, 2024

Study information
Verified date March 2024
Source Uppsala University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 5, 2024
Est. primary completion date February 5, 2024
Accepts healthy volunteers No
Gender All
Age group 0 Years to 24 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• 3 hours of preoperative fasting for breast milk
3 hours of preoperative fasting for breast milk
• 4 hours of preoperative fasting for breast milk
4 hours of preoperative fasting for breast milk

Locations
Country Name City State
Sweden Uppsala University Hospital Uppsala

Sponsors (1)
Lead Sponsor Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary CSA Gastric antrum CSA (The antral cross-sectional area) From arrival in the operating room until induction of anesthesia
Secondary Aspirated volume Aspirated volume intraoperative
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