Reducing Fasting Time in Children for Sedation | NCT05757882

Studies
Reducing Fasting Time in Children for Sedation

NCT05757882

Sponsor

Eunah Cho, MD

Status

Completed

Last Update Posted

Sep 21, 2023Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Pediatric ALL

Interventions

4 hours of fasting time
2 hours of fasting time

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2023Actual

Primary Completion Date

Aug 7, 2023Actual

Completion Date

Aug 7, 2023Actual

First Submitted Date

Feb 24, 2023

First Submission Date that Met QC Criteria

Feb 24, 2023

First Posted Date

Mar 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2023

Last Update Posted Date

Sep 21, 2023Actual

Name	Class
Samsung Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
4H	Active Comparator	Participants who are following the standard fasting time (4 hours).	Other: 4 hours of fasting time
2H	Experimental	Participants who are following minimized fasting time (2 hours)	Other: 2 hours of fasting time

Interventions

Name	Type	Description	Arm Group Labels	Other Names
4 hours of fasting time	Other	Oral intake is not allowed for 4 hours before sedation including water.	4H

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Risk of aspiration	Gastric antral cross-sectional area assessed with gastric ultrasound	10 minutes before sedation

Secondary Outcomes

Measure	Description	Time Frame
The incidence of complications	he incidence of major (pulmonary aspiration, aspiration pneumonia) and minor complications (nausea and vomiting, dehydration) between two groups.	10 minutes after sedation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pediatric patients aged under 36 months
scheduled for elective cardiac echocardiography

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jinyoung Song		Seoul	Gangnam		South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided