Perioperative ComplicationBMRCTNCT05573165
A Pilot Study of the Effects of 4 vs 3 Hours of Preoperative Fasting in Breast-feeding Infants
A study testing 3 hours of preoperative fasting for breast milk and 4 hours of preoperative fasting for breast milk in people with Perioperative Complication, run by Uppsala University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 years to 24 months
- Conditions the study is for
- Perioperative Complication
- What is being tested?
- 3 hours of preoperative fasting for breast milk and 4 hours of preoperative fasting for breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 16 Jan 2023to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Breast-feeding infanta scheduled for elective procedure requiring general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Perioperative Complication
- Being tested
- 3 hours of preoperative fasting for breast milk, 4 hours of preoperative fasting for breast milk
- Keywords
- Preoperative fasting, Anaesthesia, Children, breast-feeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 hours of preoperative fasting for breast milkOther
3 hours of preoperative fasting for breast milk
4 hours of preoperative fasting for breast milkOther
4 hours of preoperative fasting for breast milk
| Study group | Role | What they receive |
|---|---|---|
| 3h Group | Experimental | the patient's parents are instructed to stop feeding 3 hours for scheduled anesthesia. (3 hours of preoperative fasting for breast milk) Receives: Other: 3 hours of preoperative fasting for breast milk |
| 4h Group | Active comparator | the patient's parents are instructed to stop feeding 4 hours for scheduled anesthesia (4 hours of preoperative fasting for breast milk) Receives: Other: 4 hours of preoperative fasting for breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSA
Gastric antrum CSA (The antral cross-sectional area)
Measured: From arrival in the operating room until induction of anesthesia
Secondary outcomes (1)
Aspirated volume
Aspirated volume
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start16 Jan 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled pilot study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Frykholm, Uppsala University Hospital
- Investigators
- Peter Frykholm, MD, PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573165
- Sponsor's protocol ID
- BMRCT PILOT
- Acronym
- BMRCT
- Status last verified
- Mar 2024
- First submitted
- 2 Sep 2022
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effects of 4 vs 3 Hours of Preoperative Fasting in Breast-feeding Infants
- ClinicalTrials.gov ID
- NCT05573165
- Acronym / sponsor ID
- BMRCT / BMRCT PILOT
- Conditions
- Perioperative Complication
- Keywords
- Preoperative fasting, Anaesthesia, Children, breast-feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| 3h Group | Experimental | Other: 3 hours of preoperative fasting for breast milkthe patient's parents are instructed to stop feeding 3 hours for scheduled anesthesia. (3 hours of preoperative fasting for breast milk) |
| 4h Group | Active comparator | Other: 4 hours of preoperative fasting for breast milkthe patient's parents are instructed to stop feeding 4 hours for scheduled anesthesia (4 hours of preoperative fasting for breast milk) |
Who may qualify
- Ages
- 0 years to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Breast-feeding infanta scheduled for elective procedure requiring general anesthesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 hours of preoperative fasting for breast milk3 hours of preoperative fasting for breast milk | Other | 3h Group |
| 4 hours of preoperative fasting for breast milk4 hours of preoperative fasting for breast milk | Other | 4h Group |
Primary outcome
CSA
Time frame: From arrival in the operating room until induction of anesthesia
Gastric antrum CSA (The antral cross-sectional area)
1 secondary outcome
Aspirated volume
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Pre-operative fasting in children: A guideline from the European Society of Anaesthesiology and Intensive CareLink provided by the sponsor.
- Gastric content assessed with gastric ultrasound in paediatric patients prescribed a light breakfast prior to general anaesthesia: A prospective observational studyLink provided by the sponsor.
- Ultrasound assessment of gastric emptying time after intake of clear fluids in children scheduled for general anesthesia-A prospective observational studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Frykholm, MD, PhD principal investigator
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 hours of preoperative fasting for breast milk and 4 hours of preoperative fasting for breast milk in people with Perioperative Complication, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSA (time frame: From arrival in the operating room until induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.