Pediatric ALLNCT05810532
NPO Before Sedation
A study testing 4 hours of fasting time and 1 hour of fasting time in people with Pediatric ALL, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
Pre-procedural fasting is routinely conducted to prevent pulmonary aspiration regarding sedation or anesthesia. However, prolonged fasting cause hypoglycemia, dehydration, nausea, and patient discomfort. Moreover, because children have small reserved energy, prolonged fasting need to be prohibited. Read more about this study
- Who is it for?
- Ages 1 month to 3 years
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- 4 hours of fasting time and 1 hour of fasting time
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 May 2023to 11 Dec 2023
- 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 1 month to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children scheduled for elective echocardiography
- Aged under 3 years old
Who cannot join
- Comorbidity other than hear disease or chromosomal disease
- Patients with delayed gastric emptying
- Patients with structural abnormalities of the stomach or esophagus
- Difficult airway management
- Parents refuse to participate in the study
- Unable to achieve sedation
- Neonatal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on the Safety of 4-1 Hour Fasting Policy Before Sedation in Children.
Pre-procedural fasting is routinely conducted to prevent pulmonary aspiration regarding sedation or anesthesia. However, prolonged fasting cause hypoglycemia, dehydration, nausea, and patient discomfort. Moreover, because children have small reserved energy, prolonged fasting need to be prohibited.
Therefore, this study is designed to investigate the safety and efficacy of new fasting policy allowing water until 1 hour before sedation compared to the standard fasting time (4 hours of fasting including water).
- Conditions
- Pediatric ALL
- Being tested
- 4 hours of fasting time, 1 hour of fasting time
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 hours of fasting timeOther
Oral intake is not allowed for 4 hours before sedation including water
1 hour of fasting timeOther
Oral intake is not allowed for 4 hours before sedation, while water is allowed to intake before 1 hour of sedation
| Study group | Role | What they receive |
|---|---|---|
| 4H group | Active comparator | fasting more than 4 hours before sedation Receives: Other: 4 hours of fasting time |
| 1H group | Experimental | oral hydration (water) is allowed 1 hour before sedation, while other food must be fasted more than 4 hours before sedation Receives: Other: 1 hour of fasting time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric astral cross-sectional area
Gastric astral cross-sectional area measured with gastric ultrasound
Measured: 10 minutes before sedation
Secondary outcomes (3)
Estimated gastric volume
Calculated gastric volume using the formula
Measured: 10 minutes before sedation
Perlas grade
Perlas grade 0 : no risk of aspiration, Perlas grade 1 : minimal risk of aspiration, Perlas grade 2: high risk of aspiration
Measured: 10 minutes before sedation
Quality of sdeation
0, no response to pain; 1, slight response to pain; 2, response to pain; 3, response to calling
Measured: 10 minutes after sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start4 May 2023
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ALLStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810532
- Sponsor's protocol ID
- NPO1
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cho E, Song J, Huh J, Kang IS, Kim HJ, Youn IY, Lee H, Kwak JH. Evaluation of Modified Fasting Protocols to Shorten Fasting Time Before Sedation in Children: A Prospective Randomized Noninferiority Trial. Paediatr Anaesth. 2025 Sep;35(9):753-760. doi: 10.1111/pan.15142. Epub 2025 Jun 18.
PubMed 40530767
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Safety of 4-1 Hour Fasting Policy Before Sedation in Children.
- ClinicalTrials.gov ID
- NCT05810532
- Acronym / sponsor ID
- NPO1
- Conditions
- Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 12 Apr 2023 (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.
Pre-procedural fasting is routinely conducted to prevent pulmonary aspiration regarding sedation or anesthesia. However, prolonged fasting cause hypoglycemia, dehydration, nausea, and patient discomfort. Moreover, because children have small reserved energy, prolonged fasting need to be prohibited.
Therefore, this study is designed to investigate the safety and efficacy of new fasting policy allowing water until 1 hour before sedation compared to the standard fasting time (4 hours of fasting including water).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4H group | Active comparator | Other: 4 hours of fasting timefasting more than 4 hours before sedation |
| 1H group | Experimental | Other: 1 hour of fasting timeoral hydration (water) is allowed 1 hour before sedation, while other food must be fasted more than 4 hours before sedation |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children scheduled for elective echocardiography
- Aged under 3 years old
Key exclusion criteria (7 listed)
- Comorbidity other than hear disease or chromosomal disease
- Patients with delayed gastric emptying
- Patients with structural abnormalities of the stomach or esophagus
- Difficult airway management
- Parents refuse to participate in the study
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 |
|---|---|---|
| 4 hours of fasting timeOral intake is not allowed for 4 hours before sedation including water | Other | 4H group |
| 1 hour of fasting timeOral intake is not allowed for 4 hours before sedation, while water is allowed to intake before 1 hour of sedation | Other | 1H group |
Primary outcome
Gastric astral cross-sectional area
Time frame: 10 minutes before sedation
Gastric astral cross-sectional area measured with gastric ultrasound
3 secondary outcomes
Estimated gastric volume
Time frame: 10 minutes before sedation
Perlas grade
Time frame: 10 minutes before sedation
Quality of sdeation
Time frame: 10 minutes after sedation
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 3 Apr 2024.
- Derived from this study: PubMed 40530767Cho E, Song J, Huh J, Kang IS, Kim HJ, Youn IY, Lee H, Kwak JH. Evaluation of Modified Fasting Protocols to Shorten Fasting Time Before Sedation in Children: A Prospective Randomized Noninferiority Trial. Paediatr Anaesth. 2025 Sep;35(9):753-760. doi: 10.1111/pan.15142. Epub 2025 Jun 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 hours of fasting time and 1 hour of fasting time in people with Pediatric ALL, run by Kangbuk Samsung Hospital at 1 site in South Korea.
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 2 inclusion and 7 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 3 Apr 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 South Korea. 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?
Gastric astral cross-sectional area (time frame: 10 minutes before sedation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05810532, which also lists 1 linked publication.
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 3 Apr 2024.