Reducing Fasting Time for Breast Milk to 3 Hours

Study Overview
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Brief Summary
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The aim of this study is to ascertain Gastric residual volume (GRV) of gastric contents in 35 infants who are breast fed 3 hours prior to general anaesthesia. The secondary aim of this study is to ascertain how well ultrasound (USS) derived measurement of GRV, using the gastric antrum cross sectional area (ACSA), correlates to direct measurement via aspiration.

Detailed Description
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Current UK guidance recommends a fasting time of 4 hours for breast milk prior to general anaesthesia. Gastric emptying (GE) of breast milk and formula preparations has been extensively studied in neonatal intensive care settings for preterm and low birth weight infants, in order to establish optimum feeding regimens for growth. Methodologies utilised in such studies can make applying findings to current routine anaesthetic practice difficult: Such as inclusion of very low birth weight infants, use of fortified breast milk, administering feeds via nasogastric tube and pre-medication of children prior to GA with atropine. There is a paucity of evidence in breast fed, un-premedicated term babies/infants subjected to a 3 hour fast prior to GA. Pulmonary aspiration is known to be a rare event associated with lower morbidity and mortality in children than adults . In animal studies, instillation of acidified milk solutions into the lungs of anaesthetised rabbits is associated with increasing severity of lung injury as volume of solution increases above 0.8 ml/kg regardless of pH. Anaesthetising a child or adult with a full stomach is more hazardous and requires alteration of the anaesthetic technique to minimise risk of aspiration. Gastric ultrasound (USS) is a useful tool for assessing stomach volume prior to induction of anaesthesia. Various formulae have been devised to convert measured gastric antral area to volume in children. USS is validated in older children and adults in measurement of gastric ACSA and derived volume of gastric contents. We will perform a prospective, interventional study of 35 term infants aged 37 weeks to 18 months, undergoing elective surgery

Official Title
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Reducing Fasting Time for Breast Milk to 3 Hours

Conditions
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Gastric Residual Volume

Intervention / Treatment
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* Other: offering of breast milk feed 3 hours prior to p lanned surgery start


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Babies born at or after 37 weeks post menstrual age Babies born prior to 37 weeks who are now more than 37 weeks corrected post menstrual age (PMA) Elective surgery Breast fed including expressed breast milk, in isolation or combination with solids or formula. Exclusion Criteria: Babies who are less than 37 weeks PMA, Ex premature babies who are now greater than 37 weeks PMA but who have significant lung, heart, kidney or liver disease. Known delayed gastric emptying

Ages Eligible for Study
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Maximum Age: 18 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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Case series
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: recruited patients<br>recruited patients will be required to feed 3 hours prior to planned procedure start with their normal method of taking breast milk (from the breast, or expressed into a bottle). | Other: offering of breast milk feed 3 hours prior to p lanned surgery start<br>* parents will be asked to offer a breast milk feed (from breast or expressed in bottle) at a given time 3 hours prior to planned induction time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric residual volume | Ascertain the residual volume of gastric contents in 35 infants who are given breast milk 3 hours prior to general anaesthesia | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric ultrasound | The secondary aim of this study is to ascertain how well ultrasound derived measurement of gastric residual volume correlates to direct measurement via nasogastric tube aspiration. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anaesthesia, ultrasound, Breast milk, fasting, gastric