Clinical trial NCT05573165: A Pilot Study of the Effects of 4 vs 3 Hours of Preoperative Fasting in Breast-feeding Infants
Official title: A Pilot Study of the Effects of 4 vs 3 Hours of Preoperative Fasting in Breast-feeding Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Complication
Keywords: Preoperative fasting
Anaesthesia
Children
breast-feeding
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled pilot study
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: CSA
timeFrame: From arrival in the operating room until induction of anesthesia
Secondary outcomes:
measure: Aspirated volume
timeFrame: intraoperative
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Peter Frykholm, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: