Heart Defects, CongenitalNCT03411512
Congenital Heart Defects and NIRS
An observational study of Heart Defects, Congenital, run by Petja Fister, MD, PhD at 1 site in Slovenia.
Trial summary
Congenital Heart Defects and NIRS Read more about this study
- Who is it for?
- Ages 1 day to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Heart Defects, Congenital
- How many people
- 65 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Dec 2012to 31 May 2014
- 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 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: term newborns
Who may be able to join
- Investigators included term newborns with critical structural CHD (of different types) who required surgical or transcatheter procedure in the first year of life. CHD were diagnosed by pediatric cardiologist by clinical examination and echocardiography.
Who cannot join
- The exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than CHD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tissue Oxygenation in Newborns With Congenital Heart Defects
Congenital Heart Defects and NIRS
Read the detailed description
Brain, kidney and intestinal tissue oxygenation in newborns with congenital heart defects assessed by near-infrared spectroscopy.
- Conditions
- Heart Defects, Congenital
- Keywords
- congenital heart defects, near-infrared spectroscopy, newborn, tissue oxygenation
- Medical subject headings
- Heart Defects, Congenital
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 |
|---|---|---|
| CHD | Newborns with structural congenital heart defects. The exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than CHD. | |
| Healthy controls | The control group comprised of healthy matched newborns without a diagnosed CHD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rSO2
regional tissue oxygenation assessed by NIRS
Measured: RSO2 values were obtained after 30 minute calm down period to enable stable recordings on each channel by averaging five minutes recorded values.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Dec 2012
- Primary completion30 Apr 2014
- Study completion31 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petja Fister, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Petja Fister, MD, PhD, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411512
- Sponsor's protocol ID
- NIRS CHD1
- Status last verified
- Jan 2018
- First submitted
- 19 Jan 2018
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Oxygenation in Newborns With Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT03411512
- Acronym / sponsor ID
- NIRS CHD1
- Conditions
- Heart Defects, Congenital
- Keywords
- congenital heart defects, near-infrared spectroscopy, newborn, tissue oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Petja Fister, MD, PhDUniversity, hospital or other
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 30 Apr 2014 (actual)
- Study completion
- 31 May 2014 (actual)
- First posted
- 26 Jan 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.
Congenital Heart Defects and NIRS
Detailed description
Brain, kidney and intestinal tissue oxygenation in newborns with congenital heart defects assessed by near-infrared spectroscopy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHD | – | –Newborns with structural congenital heart defects. The exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than CHD. |
| Healthy controls | – | –The control group comprised of healthy matched newborns without a diagnosed CHD. |
Who may qualify
- Ages
- 1 day to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- term newborns
Key inclusion criteria (1 listed)
- Investigators included term newborns with critical structural CHD (of different types) who required surgical or transcatheter procedure in the first year of life. CHD were diagnosed by pediatric cardiologist by clinical examination and echocardiography.
Key exclusion criteria (1 listed)
- The exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than CHD.
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
rSO2
Time frame: RSO2 values were obtained after 30 minute calm down period to enable stable recordings on each channel by averaging five minutes recorded values.
regional tissue oxygenation assessed by NIRS
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 30 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Defects, Congenital, run by Petja Fister, MD, PhD at 1 site in Slovenia.
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 30 Jan 2018. 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 Slovenia. 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?
rSO2 (time frame: RSO2 values were obtained after 30 minute calm down period to enable stable recordings on each channel by averaging five minutes recorded values.). 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 30 Jan 2018.