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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2024-02-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Perioperative Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Computerized randomization,

Study Groups

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3h Group

the patient's parents are instructed to stop feeding 3 hours for scheduled anesthesia. (3 hours of preoperative fasting for breast milk)

Group Type EXPERIMENTAL

3 hours of preoperative fasting for breast milk

Intervention Type OTHER

3 hours of preoperative fasting for breast milk

4h Group

the patient's parents are instructed to stop feeding 4 hours for scheduled anesthesia (4 hours of preoperative fasting for breast milk)

Group Type ACTIVE_COMPARATOR

4 hours of preoperative fasting for breast milk

Intervention Type OTHER

4 hours of preoperative fasting for breast milk

Interventions

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3 hours of preoperative fasting for breast milk

Intervention Type OTHER

4 hours of preoperative fasting for breast milk

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No