Reducing fasting time for breast milk before surgery
Reducing Fasting Time for Breast Milk to 3 Hours
This study is testing if breastfeeding infants just 3 hours before surgery is safe and helps improve how we check their stomach contents compared to the usual 4-hour wait.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | N/A to 18 Months |
| Sex | All |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London, Greater London) |
| Trial ID | NCT05355428 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the gastric residual volume (GRV) in 35 infants who are breastfed 3 hours prior to general anaesthesia, as opposed to the current guideline of 4 hours. It will also assess the correlation between ultrasound-derived measurements of GRV and direct aspiration methods. The research addresses a gap in evidence regarding fasting times for breastfed, un-premedicated term infants undergoing elective surgery. By utilizing gastric ultrasound, the study seeks to improve safety protocols for anaesthesia in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at or after 37 weeks post menstrual age who are breastfed and scheduled for elective surgery.
Not a fit: Patients who are less than 37 weeks post menstrual age or have significant underlying health conditions affecting gastric function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer anaesthesia practices for infants by allowing shorter fasting times without increasing the risk of aspiration.
How similar studies have performed: While there is limited evidence specifically for breastfed term infants, similar studies in neonatal intensive care settings have shown the utility of gastric ultrasound in assessing gastric volume.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London, Greater London
- Emily Saffer — London, Greater London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Emily Saffer, Dr
- Email: emily.saffer@nhs.net
- Phone: 07890549924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.