Congenital Heart DiseaseCCHDNCT01749059
The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Pediatrix at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of implementing a universal pulse oximeter screening as a way to detect critical congenital heart disease in otherwise well-appearing newborns. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 6,147 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Oct 2016
- 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 Up to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates known to have a congenital heart defect at the time of screening.
Who may be able to join
- Documentation of informed consent and authorization.
- Full term and late preterm newborns (EGA 35-44 weeks)
- On room air
- Neonates known to have a congenital heart defect at the time of screening, e.g., antenatal diagnosis or diagnosis within the first 24 hours after birth
- Parents agree to follow-up contact post discharge
Who cannot join
- On supplemental oxygen
- Admitted to the Neonatal Intensive Care Unit
- Parents do not agree to follow-up
- Greater than 30 days of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Capital Health Regional Medical Center - Pediatrix Medical Group
Trenton, New Jersey, 08638
About this study
The purpose of this study is to evaluate the impact of implementing a universal pulse oximeter screening as a way to detect critical congenital heart disease in otherwise well-appearing newborns.
- Conditions
- Congenital Heart Disease
- 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 |
|---|---|---|
| Congenital Heart Defect | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
True Positive Rate
The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have CCHD.
Measured: One year follow-up
False Positive Rate
The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.
Measured: One year follow-up
True Negative Rate
The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.
Measured: One year follow-up
False Negative Rate
The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have heart defects.
Measured: One year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reese H Clark, MD, Principal investigator, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749059
- Sponsor's protocol ID
- PDX-003-11
- Acronym
- CCHD
- Status last verified
- Dec 2016
- First submitted
- 11 Dec 2012
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01749059
- Acronym / sponsor ID
- CCHD / PDX-003-11
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,147 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 Dec 2012 (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 evaluate the impact of implementing a universal pulse oximeter screening as a way to detect critical congenital heart disease in otherwise well-appearing newborns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Congenital Heart Defect | – | – |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates known to have a congenital heart defect at the time of screening.
Key inclusion criteria (5 listed)
- Documentation of informed consent and authorization.
- Full term and late preterm newborns (EGA 35-44 weeks)
- On room air
- Neonates known to have a congenital heart defect at the time of screening, e.g., antenatal diagnosis or diagnosis within the first 24 hours after birth
- Parents agree to follow-up contact post discharge
Key exclusion criteria (4 listed)
- On supplemental oxygen
- Admitted to the Neonatal Intensive Care Unit
- Parents do not agree to follow-up
- Greater than 30 days of age
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
True Positive Rate
Time frame: One year follow-up
The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have CCHD.
False Positive Rate
Time frame: One year follow-up
The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.
True Negative Rate
Time frame: One year follow-up
The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.
False Negative Rate
Time frame: One year follow-up
The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have heart defects.
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 19 Dec 2016.
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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.
Reese H Clark, MD principal investigator
Pediatrix
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 Heart Disease, run by Pediatrix 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 5 inclusion and 4 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 19 Dec 2016. 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?
True Positive Rate (time frame: One year follow-up). The study lists 4 primary outcomes in all. 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 19 Dec 2016.