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

Study Overview
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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.

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.

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

Conditions
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Perioperative Complication

Intervention / Treatment
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* Other: 3 hours of preoperative fasting for breast milk
* Other: 4 hours of preoperative fasting for breast milk


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized controlled pilot study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3h Group<br>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<br>* 3 hours of preoperative fasting for breast milk<br>|
| Active Comparator: 4h Group<br>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<br>* 4 hours of preoperative fasting for breast milk<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative fasting, Anaesthesia, Children, breast-feeding