Congenital Cardiovascular MalformationNCT01765205
Newborn Screening for Critical Congenital Heart Disease
An observational study of Congenital Cardiovascular Malformation, run by University of Florida at 1 site in United States.
Trial summary
Previous studies have examined the usefulness of pulse oximetry or oxygen saturation to screen for left-sided cardiac lesions. These studies have shown that the occurrence of critical congenital cardiac malformations among asymptomatic newborns is high; the technique of pulse oximetry is reliable for detection of… Read more about this study
- Who is it for?
- Ages 12 hours to 2 weeksHealthy volunteers can take part
- Conditions the study is for
- Congenital Cardiovascular Malformation
- What is being tested?
- Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jan 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 12 hours to 2 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy newborns and newborns diagnosed with congenital cardiovascular malformations
Who may be able to join
- Male or female subjects aged 12 hours -2 weeks.
- Newborns with identified congenital heart disease or newborns without identified congenital heart disease.
- Congenital Heart Diagnosis: Total Anomolous Pulmonary Venous Return (TAPVR); Atrio-ventricular Septal Defect ( AVSD); Coarctation of the Aorta; Critical Aortic Stenosis; other cyanotic legions including Hypoplastic Left Heart Syndrome ( HLHS)
Who cannot join
- Have any concurrent condition which, in the opinion of the investigator, would make the subject unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands Hospital at the University of Florida
Gainesville, Florida, 32610
About this study
Official title: The Efficacy of Newborn Screening for Critical Congenital Heart Disease
Previous studies have examined the usefulness of pulse oximetry or oxygen saturation to screen for left-sided cardiac lesions. These studies have shown that the occurrence of critical congenital cardiac malformations among asymptomatic newborns is high; the technique of pulse oximetry is reliable for detection of ductal dependant left-sided lesions, simple to operate(requires little time and can be done in the newborn nursery) and is cost effective; there is effective follow-up test (heart ultrasound) and available interventions have an effect on outcome for diagnosed newborns. The importance of this research project is to examine the overall helpfulness of measuring oximetry in newborn infants using somatic oximetry, as well ast to prepare for a population based study in the state of Florida.
Read the detailed description
This study will evaluate up to 50 unaffected newborns and up to 10 known congenital heart disease (CHD) newborns using a new oximetry system. This system is interfaced to a laptop computer which computes the difference between central and lower extremity peripheral values, upper and lower body peripheral values, and records all data. This information may differentiate unaffected newborns and CHD newborns, and determine the effectiveness of pulse oximetry as a newborn screening for congenital cardiovascular malformations.
- Conditions
- Congenital Cardiovascular Malformation
- Being tested
- Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter
- Keywords
- congenital cardiovascular malformation, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic OximeterDevice
Also called Healthy Newborns with Pulse oximetry
Up to 50 healthy infants and up to 10 infants with CHD will receive the pulse oximetry using the INVOS Cerebral/Somatic Oximeter for 15 minutes to determine the effectiveness to measure somatic oxygen saturation. The pulse oximeter will be placed on the infants forehead with a hat and around the infants thigh to measure oxygen saturation.
| Study group | Role | What they receive |
|---|---|---|
| Newborns with Pulse oximetry | Up to 50 healthy newborn participants will receive 15 minutes of pulse oximetry to determine the effectiveness of measuring somatic oxygen saturation. Receives: Device: Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter | |
| CHD infant with pulse oximetry | Up to 10 infants diagnosed with congenital heart disease will receive 15 minutes of pulse oximetry using the INVOS Cerebral/Somatic Oximeter to determine the effectiveness of measuring somatic oxygen saturation. Receives: Device: Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the oxygen saturation using pulse oximetry.
The oxygen saturation will be measured by pulse oximetry on an infant's skin on the forehead and thigh. These two numbers will be recorded as whole numbers on the machine and will be compared to both groups of infants.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startMar 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Cardiovascular MalformationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barry J Byrne, MD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765205
- Sponsor's protocol ID
- IRB 118-2010
- Status last verified
- Mar 2014
- First submitted
- 6 Dec 2012
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Newborn Screening for Critical Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01765205
- Acronym / sponsor ID
- IRB 118-2010
- Conditions
- Congenital Cardiovascular Malformation
- Keywords
- congenital cardiovascular malformation, newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Jan 2013 (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.
Previous studies have examined the usefulness of pulse oximetry or oxygen saturation to screen for left-sided cardiac lesions. These studies have shown that the occurrence of critical congenital cardiac malformations among asymptomatic newborns is high; the technique of pulse oximetry is reliable for detection of ductal dependant left-sided lesions, simple to operate(requires little time and can be done in the newborn nursery) and is cost effective; there is effective follow-up test (heart ultrasound) and available interventions have an effect on outcome for diagnosed newborns. The importance of this research project is to examine the overall helpfulness of measuring oximetry in newborn infants using somatic oximetry, as well ast to prepare for a population based study in the state of Florida.
Detailed description
This study will evaluate up to 50 unaffected newborns and up to 10 known congenital heart disease (CHD) newborns using a new oximetry system. This system is interfaced to a laptop computer which computes the difference between central and lower extremity peripheral values, upper and lower body peripheral values, and records all data. This information may differentiate unaffected newborns and CHD newborns, and determine the effectiveness of pulse oximetry as a newborn screening for congenital cardiovascular malformations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newborns with Pulse oximetry | – | Device: Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic OximeterUp to 50 healthy newborn participants will receive 15 minutes of pulse oximetry to determine the effectiveness of measuring somatic oxygen saturation. |
| CHD infant with pulse oximetry | – | Device: Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic OximeterUp to 10 infants diagnosed with congenital heart disease will receive 15 minutes of pulse oximetry using the INVOS Cerebral/Somatic Oximeter to determine the effectiveness of measuring somatic oxygen saturation. |
Who may qualify
- Ages
- 12 hours to 2 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy newborns and newborns diagnosed with congenital cardiovascular malformations
Key inclusion criteria (3 listed)
- Male or female subjects aged 12 hours -2 weeks.
- Newborns with identified congenital heart disease or newborns without identified congenital heart disease.
- Congenital Heart Diagnosis: Total Anomolous Pulmonary Venous Return (TAPVR); Atrio-ventricular Septal Defect ( AVSD); Coarctation of the Aorta; Critical Aortic Stenosis; other cyanotic legions including Hypoplastic Left Heart Syndrome ( HLHS)
Key exclusion criteria (1 listed)
- Have any concurrent condition which, in the opinion of the investigator, would make the subject unsuitable for the study.
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 |
|---|---|---|
| Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic OximeterAlso: Healthy Newborns with Pulse oximetryUp to 50 healthy infants and up to 10 infants with CHD will receive the pulse oximetry using the INVOS Cerebral/Somatic Oximeter for 15 minutes to determine the effectiveness to measure somatic oxygen saturation. The pulse oximeter will be placed on the infants forehead with a hat and around the infants thigh to measure oxygen saturation. | Device | CHD infant with pulse oximetry, Newborns with Pulse oximetry |
Primary outcome
To measure the oxygen saturation using pulse oximetry.
Time frame: Baseline
The oxygen saturation will be measured by pulse oximetry on an infant's skin on the forehead and thigh. These two numbers will be recorded as whole numbers on the machine and will be compared to both groups of infants.
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 14 Mar 2014.
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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.
Barry J Byrne, MD, PhD principal investigator
University of Florida
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 Congenital Cardiovascular Malformation, run by University of Florida 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 3 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 14 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 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?
To measure the oxygen saturation using pulse oximetry. (time frame: Baseline). 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 14 Mar 2014.