Dehydration in ChildrenNCT03670394
Capillary Refill for Assessment of Dehydration
An observational study of Dehydration in Children, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Capillary refill is used clinically to assess multiple things in children. This is a prospective observational study of the correlation between capillary refill time and degree of dehydration in children seen in a pediatric ED. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Dehydration in Children
- What is being tested?
- Capillary Refill
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 1 Apr 2020
- Phase
- Observational
- 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 6 months to 10 years
- All sexes
- Child
Study population: All patients presenting to the pediatric ER at OHSu.
Who may be able to join
- All children with chief complaint of diarrhea, emesis, nausea, abdominal pain
Who cannot join
- Any child with chronic cardiac or pulm disease, raynauds syndrome, bilateral upper extremity trauma, previously enrolled in the study, already received IVF in the previous 48hrs, surgery within 1week, osteogenesis imperfecta.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capillary Refill to Detect Dehydration in Children
Capillary refill is used clinically to assess multiple things in children. This is a prospective observational study of the correlation between capillary refill time and degree of dehydration in children seen in a pediatric ED.
Read the detailed description
All patient presenting to the pediatric ER at OHSU less than 10 years are eligible to be enrolled if being seen for a condition putting them at risk for dehydration including emesis, diarrhea, etc. Children will have their capillary refill time measured and then sent home with a digital scale to track their weight. This will serve as the standard for calculating percent dehydration. When a patient has reached a stable weight at 1 week we will assume this is their healthy weight. There is no intervention in the study.
- Conditions
- Dehydration in Children
- Being tested
- Capillary Refill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary RefillDiagnostic test
We are measuring capillary refill to assess it's correlation with dehydration in children
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary Refill time
Assessing correlation of the refill time and percent dehydration
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start10 Sep 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dehydration in ChildrenStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. David Sheridan, Oregon Health and Science University
- Investigators
- David Sheridan, MD MR, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670394
- Sponsor's protocol ID
- Dehydration Assessment
- Status last verified
- Apr 2020
- First submitted
- 12 Sep 2018
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capillary Refill to Detect Dehydration in Children
- ClinicalTrials.gov ID
- NCT03670394
- Acronym / sponsor ID
- Dehydration Assessment
- Conditions
- Dehydration in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 13 Sep 2018 (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.
Capillary refill is used clinically to assess multiple things in children. This is a prospective observational study of the correlation between capillary refill time and degree of dehydration in children seen in a pediatric ED.
Detailed description
All patient presenting to the pediatric ER at OHSU less than 10 years are eligible to be enrolled if being seen for a condition putting them at risk for dehydration including emesis, diarrhea, etc. Children will have their capillary refill time measured and then sent home with a digital scale to track their weight. This will serve as the standard for calculating percent dehydration. When a patient has reached a stable weight at 1 week we will assume this is their healthy weight. There is no intervention in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- All patients presenting to the pediatric ER at OHSu.
Key inclusion criteria (1 listed)
- All children with chief complaint of diarrhea, emesis, nausea, abdominal pain
Key exclusion criteria (1 listed)
- Any child with chronic cardiac or pulm disease, raynauds syndrome, bilateral upper extremity trauma, previously enrolled in the study, already received IVF in the previous 48hrs, surgery within 1week, osteogenesis imperfecta.
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 |
|---|---|---|
| Capillary RefillWe are measuring capillary refill to assess it's correlation with dehydration in children | Diagnostic test | – |
Primary outcome
Capillary Refill time
Time frame: 1 week
Assessing correlation of the refill time and percent dehydration
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 17 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Dehydration in Children
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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.
David Sheridan, MD MR principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration in Children, run by Oregon Health and Science University 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 1 inclusion and 1 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 17 Apr 2020. 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?
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?
Capillary Refill time (time frame: 1 week). 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 17 Apr 2020.