Dehydration in ChildrenNCT03712189
LifeFlow Fluid Study- Non- Critical Pediatric Patients Having a Trans Abdominal Ultrasound
A study testing LifeFlow in people with Dehydration in Children and Dehydration, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
This is an unblinded, randomized control study examining two fluid delivery modalities for non-critical female patients with a planned transabdominal pelvic ultrasound requiring intravenous fluid boluses. Read more about this study
- Who is it for?
- Ages 1 month to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dehydration in Children, Dehydration
- What is being tested?
- LifeFlow
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female patients older than 1 month and less than 18 years
- Patients require IV crystalloid bolus fluids before a pelvic ultrasound
Who cannot join
- Known cardiac insufficiency or significant cardiac surgery
- Hepatic insufficiency
- Renal insufficiency
- Any known fluid overload states (ascites, pulmonary edema)
- On any diuretic or antihypertensive therapy
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90026
About this study
Official title: The Utility of LifeFlow Rapid Fluid Infuser in Critical and Non-critical Pediatric Patients: a Mixed-method Pilot Study Protocol
This is an unblinded, randomized control study examining two fluid delivery modalities for non-critical female patients with a planned transabdominal pelvic ultrasound requiring intravenous fluid boluses.
Read the detailed description
Subjects be identified during their clinical course in the ED and will be randomized to either the LifeFlow® fluid delivery or an IV fluid bolus through the Alaris® pump (standard of care). IV fluids will be provided until the subject notes the sensation of a full bladder, at which point, the standard of care clinical practice is to perform the ultrasound. The transabdominal pelvic ultrasound requires a full bladder for optimal visualization of the ovaries, adnexa, and uterus, and is the only alternative to a transvaginal pelvic ultrasound for virginal young women. All other clinical care is per standard of care. The only research component is the randomization and data collection.
- Conditions
- Dehydration in Children, Dehydration
- Being tested
- LifeFlow
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeFlowDevice
The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release.
| Study group | Role | What they receive |
|---|---|---|
| Alaris Pump | No intervention | Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full. |
| LifeFlow | Experimental | Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full. Receives: Device: LifeFlow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration- Ultrasound Ordered to Completed
The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound.
Measured: From ED (Emergency Department) arrival to discharge/admission, less than 12 hours
Secondary outcomes (2)
Total IV Fluid (mL)
Total IV fluid administered before ultrasound
Measured: From ED arrival to discharge/admission, less than 12 hours
Duration- Full Bladder
Fluid initiation and subjective sensation of full bladder
Measured: From ED arrival to discharge/admission, less than 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start2 Oct 2018
- Primary completion31 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dehydration in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- 410 Medical, Atlanta Pediatric Device Consortium
- Responsible party
- Principal investigator, Todd P Chang, MD MAcM, Children's Hospital Los Angeles
- Investigators
- Todd P Chang, MD, Principal investigator, Children's Hospital Los AngelesAra Festekjian, MD, Study director, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712189
- Sponsor's protocol ID
- CHLA-18-00188
- Status last verified
- Jan 2024
- First submitted
- 11 Oct 2018
- Last updated
- 8 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kline M, Crispino L, Bhatnagar A, Panchal RA, Auerbach M. A Randomized Single-Blinded Simulation-Based Trial of a Novel Method for Fluid Administration to a Septic Infant. Pediatr Emerg Care. 2021 Jun 1;37(6):e313-e318. doi: 10.1097/PEC.0000000000001583.
PubMed 30106868
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of LifeFlow Rapid Fluid Infuser in Critical and Non-critical Pediatric Patients: a Mixed-method Pilot Study Protocol
- ClinicalTrials.gov ID
- NCT03712189
- Acronym / sponsor ID
- CHLA-18-00188
- Conditions
- Dehydration in Children, Dehydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- 410 Medical, Atlanta Pediatric Device Consortium
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an unblinded, randomized control study examining two fluid delivery modalities for non-critical female patients with a planned transabdominal pelvic ultrasound requiring intravenous fluid boluses.
Detailed description
Subjects be identified during their clinical course in the ED and will be randomized to either the LifeFlow® fluid delivery or an IV fluid bolus through the Alaris® pump (standard of care). IV fluids will be provided until the subject notes the sensation of a full bladder, at which point, the standard of care clinical practice is to perform the ultrasound. The transabdominal pelvic ultrasound requires a full bladder for optimal visualization of the ovaries, adnexa, and uterus, and is the only alternative to a transvaginal pelvic ultrasound for virginal young women. All other clinical care is per standard of care. The only research component is the randomization and data collection.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alaris Pump | No intervention | –Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full. |
| LifeFlow | Experimental | Device: LifeFlowParticipants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Female patients older than 1 month and less than 18 years
- Patients require IV crystalloid bolus fluids before a pelvic ultrasound
Key exclusion criteria (6 listed)
- Known cardiac insufficiency or significant cardiac surgery
- Hepatic insufficiency
- Renal insufficiency
- Any known fluid overload states (ascites, pulmonary edema)
- On any diuretic or antihypertensive therapy
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 |
|---|---|---|
| LifeFlowThe LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release. | Device | LifeFlow |
Primary outcome
Duration- Ultrasound Ordered to Completed
Time frame: From ED (Emergency Department) arrival to discharge/admission, less than 12 hours
The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound.
2 secondary outcomes
Total IV Fluid (mL)
Time frame: From ED arrival to discharge/admission, less than 12 hours
Duration- Full Bladder
Time frame: From ED arrival to discharge/admission, less than 12 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30106868Kline M, Crispino L, Bhatnagar A, Panchal RA, Auerbach M. A Randomized Single-Blinded Simulation-Based Trial of a Novel Method for Fluid Administration to a Septic Infant. Pediatr Emerg Care. 2021 Jun 1;37(6):e313-e318. doi: 10.1097/PEC.0000000000001583.
- 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.
Todd P Chang, MD principal investigator
Children's Hospital Los Angeles
Ara Festekjian, MD study director
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeFlow in people with Dehydration in Children and Dehydration, run by Children's Hospital Los Angeles at 1 site in United States.
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 6 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 8 Jan 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration- Ultrasound Ordered to Completed (time frame: From ED (Emergency Department) arrival to discharge/admission, less than 12 hours). 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 NCT03712189, 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 8 Jan 2024.