DiarrheaIHM-01NCT01482208
Clinical Evaluation of Ultrasonic Hydration Monitor for Infants
An observational study of Diarrhea and Dehydration, run by Artann Laboratories at 1 site in Latvia.
Trial summary
Study will verify ability of infant Hydration Monitor (IHM) to assess changes of hydration status in newborns and infants by means of ultrasound velocity measurements through muscle tissues. Read more about this study
- Who is it for?
- Ages 1 day to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Dehydration
- How many people
- 42 participants
- Where
- 1 siteLatvia
- Study dates
- Nov 2011to Oct 2012
- 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 1 day to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborns from 1 to 7 days Small children from 1 month to 3 years old
Who may be able to join
- Newborns from 1 to 7 days old,
- Health infants from 1 month to 3 years old,
- Any ethnicity,
- Male or female,
- Infants with diarrhea,
- Acute gastroenteritis,
- Diarrhea and/or vomiting,
- Suspected dehydration
Who cannot join
- Congenital heart disease,
- Renal failure,
- Chronic liver disease,
- Chronic lung disease,
- Inflammatory bowel disease,
- Immune deficiency,
Show all 9Show fewer
- Severe malnutrition,
- Any external damage to skin of leg,
- Infants and Children whose parents refuse permission to be included
Trial locations and contacts
1 site in 1 country.
Latvia1 site
Children Clinical University Hospital (CCUH) of the Riga Stradinsh University (RSU)
Riga, LV-1004
About this study
Official title: Study of Ultrasonic Hydration Monitor for Neonatology and Pediatric Children and Infants and/or Children up to Age 3 Years Old With Diarrhea
Study will verify ability of infant Hydration Monitor (IHM) to assess changes of hydration status in newborns and infants by means of ultrasound velocity measurements through muscle tissues. Changes of tissue hydration will be followed during first days of life in newborns and in acute diarrhea in small children during re-hydration therapy. Weighting and clinical dehydration symptoms will be used as controls.
- Conditions
- Diarrhea, Dehydration
- Keywords
- Dehydration, Hydration, Muscle composition, Diarrhea, Pediatrics, Neonatology, Ultrasound
- Medical subject headings
- Diarrhea, Dehydration
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the ability of IHM to measure changes of hydration status ni newborn and infants
Infants and small children diagnosed with diarrhea or presenting to the hopsital with diseases known to cause dehydration are eligible
Measured: 1 week to several months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artann Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Dace Gardovska, Dr. Med., Principal investigator, Head of Pediatrics, CCUH RSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482208
- Sponsor's protocol ID
- IHM-01
- Other IDs
- Gates Foundation
- Acronym
- IHM-01
- Status last verified
- Mar 2014
- First submitted
- 28 Nov 2011
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Ultrasonic Hydration Monitor for Neonatology and Pediatric Children and Infants and/or Children up to Age 3 Years Old With Diarrhea
- ClinicalTrials.gov ID
- NCT01482208
- Acronym / sponsor ID
- IHM-01 / IHM-01
- Conditions
- Diarrhea, Dehydration
- Keywords
- Dehydration, Hydration, Muscle composition, Diarrhea, Pediatrics, Neonatology, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Artann LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 Nov 2011 (estimated)
- 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.
Study will verify ability of infant Hydration Monitor (IHM) to assess changes of hydration status in newborns and infants by means of ultrasound velocity measurements through muscle tissues. Changes of tissue hydration will be followed during first days of life in newborns and in acute diarrhea in small children during re-hydration therapy. Weighting and clinical dehydration symptoms will be used as controls.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborns from 1 to 7 days Small children from 1 month to 3 years old
Key inclusion criteria (8 listed)
- Newborns from 1 to 7 days old,
- Health infants from 1 month to 3 years old,
- Any ethnicity,
- Male or female,
- Infants with diarrhea,
Key exclusion criteria (9 listed)
- Congenital heart disease,
- Renal failure,
- Chronic liver disease,
- Chronic lung disease,
- Inflammatory bowel disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the ability of IHM to measure changes of hydration status ni newborn and infants
Time frame: 1 week to several months
Infants and small children diagnosed with diarrhea or presenting to the hopsital with diseases known to cause dehydration are eligible
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 31 Mar 2014.
- Sponsor Link to Reference #9Link provided by the sponsor.
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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.
Dace Gardovska, Dr. Med. principal investigator
Head of Pediatrics, CCUH RSU
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 Diarrhea and Dehydration, run by Artann Laboratories at 1 site in Latvia.
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 8 inclusion and 9 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 31 Mar 2014. 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 Latvia. 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?
Assess the ability of IHM to measure changes of hydration status ni newborn and infants (time frame: 1 week to several months). 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 31 Mar 2014.