Colloid Osmotic PressureNCT01044940
Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma in Healthy and Sick Children
An observational study of Colloid Osmotic Pressure, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to measure colloid osmotic pressure in interstitial fluid and plasma in healthy children under two years, in asphyxiated babies and in children undergoing heart surgery. Read more about this study
- Who is it for?
- Ages 1 hour to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Colloid Osmotic Pressure
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2010to Jan 2015
- 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 hour to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Asphyxiated babyes Children with heart defects who need surgery Newborn who need blood transfusion
Who may be able to join
- Newborn
Who cannot join
- Syndromes
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to measure colloid osmotic pressure in interstitial fluid and plasma in healthy children under two years, in asphyxiated babies and in children undergoing heart surgery.
- Conditions
- Colloid Osmotic Pressure
- Keywords
- Colloid Osmotic pressure in interstitial fluid, Colloid Osmotic pressure in plasma, Protein fractions in interstitial fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Birth asphyxia | Babies suffering from birth asphyxia | |
| Blood transfusion | Babies who receives blood transfusion | |
| Heart Surgery | Babies who need heart surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colloid osmotic pressure
Measured: 6, 12, 24, 48, 72 hours post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colloid Osmotic PressureStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Joergen T Guthe, MD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044940
- Sponsor's protocol ID
- 093137
- Status last verified
- Sep 2015
- First submitted
- 7 Jan 2010
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Guthe HJT, Nedrebo T, Damas JK, Wiig H, Berg A. Transcapillary fluid flux and inflammatory response during neonatal therapeutic hypothermia: an open, longitudinal, observational study. BMC Pediatr. 2018 Feb 23;18(1):82. doi: 10.1186/s12887-018-1020-3.
PubMed 29471782
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma in Healthy and Sick Children
- ClinicalTrials.gov ID
- NCT01044940
- Acronym / sponsor ID
- 093137
- Conditions
- Colloid Osmotic Pressure
- Keywords
- Colloid Osmotic pressure in interstitial fluid, Colloid Osmotic pressure in plasma, Protein fractions in interstitial fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Jan 2010 (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.
The purpose of this study is to measure colloid osmotic pressure in interstitial fluid and plasma in healthy children under two years, in asphyxiated babies and in children undergoing heart surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Birth asphyxia | – | –Babies suffering from birth asphyxia |
| Blood transfusion | – | –Babies who receives blood transfusion |
| Heart Surgery | – | –Babies who need heart surgery |
Who may qualify
- Ages
- 1 hour to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Asphyxiated babyes Children with heart defects who need surgery Newborn who need blood transfusion
Key inclusion criteria (1 listed)
- Newborn
Key exclusion criteria (1 listed)
- Syndromes
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
Colloid osmotic pressure
Time frame: 6, 12, 24, 48, 72 hours post partum
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 10 Sep 2015.
- Derived from this study: PubMed 29471782Guthe HJT, Nedrebo T, Damas JK, Wiig H, Berg A. Transcapillary fluid flux and inflammatory response during neonatal therapeutic hypothermia: an open, longitudinal, observational study. BMC Pediatr. 2018 Feb 23;18(1):82. doi: 10.1186/s12887-018-1020-3.
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.
Hans Joergen T Guthe, MD principal investigator
Haukeland University Hospital
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 Colloid Osmotic Pressure, run by Haukeland University Hospital at 1 site in Norway.
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 10 Sep 2015. 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 Norway. 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?
Colloid osmotic pressure (time frame: 6, 12, 24, 48, 72 hours post partum). 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 NCT01044940, 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 10 Sep 2015.