Pediatric ALLNCT05757882
Reducing Fasting Time in Children for Sedation
A study testing 4 hours of fasting time and 2 hours of fasting time in people with Pediatric ALL, run by Eunah Cho, MD at 1 site in South Korea.
Trial summary
Patients are asked to be fasted for certain period of time before sedation to reduce the risk of pulmonary aspiration. However, fasting can be harmful, especially in children who has smaller reserves of energy and fluids compared to the adults. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- 4 hours of fasting time and 2 hours of fasting time
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 May 2023to 7 Aug 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 Up to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- pediatric patients aged under 36 months
- scheduled for elective cardiac echocardiography
Who cannot join
- patients with disease that delay gastric emptying
- patients taking medication that delay gastric emptying
- structural deformities, or abnormalities that interrupt gastric ultrasound
- refuse to participate in the study
- sedation is failed or impossible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Gastric Ultrasound for Reduction of Fasting Time in Children for Sedation
Patients are asked to be fasted for certain period of time before sedation to reduce the risk of pulmonary aspiration. However, fasting can be harmful, especially in children who has smaller reserves of energy and fluids compared to the adults. Prolonged fasting may increase nausea, vomiting, dehydration, and hypoglycemia. Therefore, it is important to minimize prolonged fasting time in pediatric patients.
This study is aimed to investigate the safety of minimal fasting time (2 hours) compared to the standard fasting time (4 hours) with gastric ultrasound.
- Conditions
- Pediatric ALL
- Being tested
- 4 hours of fasting time, 2 hours 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.
2 hours of fasting timeOther
Oral intake is not allowed for 2 hours before sedation including water.
| Study group | Role | What they receive |
|---|---|---|
| 4H | Active comparator | Participants who are following the standard fasting time (4 hours). Receives: Other: 4 hours of fasting time |
| 2H | Experimental | Participants who are following minimized fasting time (2 hours) Receives: Other: 2 hours of fasting time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of aspiration
Gastric antral cross-sectional area assessed with gastric ultrasound
Measured: 10 minutes before sedation
Secondary outcomes (1)
The incidence of complications
he incidence of major (pulmonary aspiration, aspiration pneumonia) and minor complications (nausea and vomiting, dehydration) between two groups.
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 posted7 Mar 2023
- Study start25 May 2023
- Primary completion7 Aug 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunah Cho, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center
- Responsible party
- Sponsor-investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757882
- Sponsor's protocol ID
- NPO2
- Status last verified
- Sep 2023
- First submitted
- 24 Feb 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gastric Ultrasound for Reduction of Fasting Time in Children for Sedation
- ClinicalTrials.gov ID
- NCT05757882
- Acronym / sponsor ID
- NPO2
- Conditions
- Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Eunah Cho, MDUniversity, hospital or other
- Collaborators
- Samsung Medical Center
- Study start
- 25 May 2023 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 7 Mar 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.
Patients are asked to be fasted for certain period of time before sedation to reduce the risk of pulmonary aspiration. However, fasting can be harmful, especially in children who has smaller reserves of energy and fluids compared to the adults. Prolonged fasting may increase nausea, vomiting, dehydration, and hypoglycemia. Therefore, it is important to minimize prolonged fasting time in pediatric patients.
This study is aimed to investigate the safety of minimal fasting time (2 hours) compared to the standard fasting time (4 hours) with gastric ultrasound.
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 | Active comparator | Other: 4 hours of fasting timeParticipants who are following the standard fasting time (4 hours). |
| 2H | Experimental | Other: 2 hours of fasting timeParticipants who are following minimized fasting time (2 hours) |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- pediatric patients aged under 36 months
- scheduled for elective cardiac echocardiography
Key exclusion criteria (5 listed)
- patients with disease that delay gastric emptying
- patients taking medication that delay gastric emptying
- structural deformities, or abnormalities that interrupt gastric ultrasound
- refuse to participate in the study
- sedation is failed or impossible
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 |
| 2 hours of fasting timeOral intake is not allowed for 2 hours before sedation including water. | Other | 2H |
Primary outcome
Risk of aspiration
Time frame: 10 minutes before sedation
Gastric antral cross-sectional area assessed with gastric ultrasound
1 secondary outcome
The incidence of complications
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 21 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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 2 hours of fasting time in people with Pediatric ALL, run by Eunah Cho, MD 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 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 21 Sep 2023. 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?
Risk of aspiration (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?
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 21 Sep 2023.