Congenital Heart DiseasePOXNCT02731248
Pulse Oximeter Screening in Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Dr. Sami Ulus Children's Hospital at 6 sites in Turkey (Türkiye).
Trial summary
Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey Read more about this study
- Who is it for?
- Ages 1 day to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Prospective screening study
- How many people
- 50,000 participants
- Where
- 6 sitesTurkey (Türkiye)
- Study dates
- Apr 2016to May 2017
- 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 5 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Babies within the first 24-72 hours followed up in well baby nurseries
Who may be able to join
- Babies within the first 24-72 hours followed up in well baby nurseries
- Babies prior to discharge, if discharged before 24 hours of age,
- Babies ≤5 days and still followed up in well baby nurseries
- Babies born ≥35 gestational weeks
Who cannot join
- Babies within the first 12 hours of life
- Babies >5 days of life
- Babies with a gestational age of >35 weeks
- Babies with major congenital anomaly except congenial heart disease
- Babies who had a prenatal diagnosis of congenital heart disease
Trial locations and contacts
6 sites in 1 country.
Dilek Dilli, Assoc Prof contact
6 sites in 1 country
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Dr Sami Ulus Children Hospital
Ankara, Ankara, 06120
Dilek Dilli, Assoc prof, 00903123056000 ext. 6310, dilekdilli2@yahoo.com
Ayşen Gök, MD
- Recruiting
Bursa Sevket Yılmaz Training and Research Hospital
Bursa
Arzu Akdağ, MD
- Recruiting
Ataturk University Medical Faculty
Erzurum
İbrahim Caner, MD
MD
- Recruiting
Mersin Maternity Hospital
Mersin
Banu Mutlu, MD
- Recruiting
Mugla Sıtkı Koçman University Medical Faculty
Muğla
Nilay Hakan, MD
MD
- Recruiting
Urfa Maternity Hospital
Sanliurfa
Akan Yaman, MD
MD
About this study
Official title: Pulse Oximeter Screening for Critical Congenital Heart Disease in Newborns
Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey
Read the detailed description
The early detection of life-threatening, critical congenital heart defects in newborn babies still presents an important clinical challenge. Most defects are amenable to intervention but timely diagnosis (ie, before presentation with cardiovascular collapse or death) is crucial. In high-income countries, examination and, increasingly, antenatal ultrasound have formed the basis of screening, but test accuracy of these procedures is variable and many babies with critical congenital heart defects are discharged before diagnosis. Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey
- Conditions
- Congenital Heart Disease
- Being tested
- Prospective screening study
- 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.
Prospective screening studyOther
Prospective screening study in newborns
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse oximeter positivity
Congenital heart disease detection by pulse oximeter
Measured: 6 months
Secondary outcomes (1)
echocardiographic confirmation
echocardiographic confirmation of congenital heart disease
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
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
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sami Ulus Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Dilli, Dr. Sami Ulus Children's Hospital
- Investigators
- Dilek Dilli, Assoc Prof, Study chair, DR sami Ulus Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731248
- Sponsor's protocol ID
- SamiUlusCH-CHD
- Acronym
- POX
- Status last verified
- Apr 2016
- First submitted
- 2 Apr 2016
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Oximeter Screening for Critical Congenital Heart Disease in Newborns
- ClinicalTrials.gov ID
- NCT02731248
- Acronym / sponsor ID
- POX / SamiUlusCH-CHD
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Dr. Sami Ulus Children's HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 7 Apr 2016 (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.
Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey
Detailed description
The early detection of life-threatening, critical congenital heart defects in newborn babies still presents an important clinical challenge. Most defects are amenable to intervention but timely diagnosis (ie, before presentation with cardiovascular collapse or death) is crucial. In high-income countries, examination and, increasingly, antenatal ultrasound have formed the basis of screening, but test accuracy of these procedures is variable and many babies with critical congenital heart defects are discharged before diagnosis. Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Babies within the first 24-72 hours followed up in well baby nurseries
Key inclusion criteria (4 listed)
- Babies within the first 24-72 hours followed up in well baby nurseries
- Babies prior to discharge, if discharged before 24 hours of age,
- Babies ≤5 days and still followed up in well baby nurseries
- Babies born ≥35 gestational weeks
Key exclusion criteria (5 listed)
- Babies within the first 12 hours of life
- Babies >5 days of life
- Babies with a gestational age of >35 weeks
- Babies with major congenital anomaly except congenial heart disease
- Babies who had a prenatal diagnosis of congenital heart disease
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 |
|---|---|---|
| Prospective screening studyProspective screening study in newborns | Other | – |
Primary outcome
pulse oximeter positivity
Time frame: 6 months
Congenital heart disease detection by pulse oximeter
1 secondary outcome
echocardiographic confirmation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Dilek Dilli, Assoc Prof contact
Dilek Dilli, Assoc Prof study chair
DR sami Ulus Training and Research Hospital
6 sites 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 Dr. Sami Ulus Children's Hospital at 6 sites in Turkey (Türkiye).
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek Dilli, Assoc Prof (+905422368250), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulse oximeter positivity (time frame: 6 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 7 Apr 2016.