Congenital Heart DiseaseNSCHDNCT01665261
Newborn Screening for Congenital Heart Disease
An observational study of Congenital Heart Disease, run by Children's Hospital of Fudan University at 2 sites in China.
Trial summary
The purpose of this study is to test the accuracy of 7 indicators in screening congenital heart defects (CHD) in all newborns (symptomatic or asymptomatic) to determine whether these indicators could be applied in the nationwide newborn CHD screening. Read more about this study
- Who is it for?
- Ages 6 to 72 hours
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 6,730 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2012to Feb 2013
- 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 6 to 72 hours
- All sexes
- No healthy volunteers
- Child
Study population: All consecutive neonates including pre-mature neonates and symptomatic neonates) will be recruited prospectively from two collaboration hospitals of the ongoing projects- "Key Clinical Research Project Sponsored by Ministry of Health Screening, evaluation and intervention of congenital heart disease in newborn infants(2010-239)"
Who may be able to join
- all consecutive live newborn infants
- between 6-72hours of age
Who cannot join
- declining the screening;
- early discharge before the screening;
- missing
Trial locations and contacts
2 sites in 1 country.
China2 sites
Songjiang District Central Hospital
Shanghai, Shanghai Municipality, 201620
Songjiang Maternal and Child Health Hospital
Shanghai, Shanghai Municipality, 201620
About this study
Official title: Accuracy Assessment of 7 Clinical Indicators in Newborn Screening for Congenital Heart Disease
The purpose of this study is to test the accuracy of 7 indicators in screening congenital heart defects (CHD) in all newborns (symptomatic or asymptomatic) to determine whether these indicators could be applied in the nationwide newborn CHD screening. The investigator's hypothesis is that 7 indicators are effective in neonate CHD screening with the acceptable accuracy.
Read the detailed description
Congenital heart defects (CHD) are among the most common major congenital anomalies, and they occur worldwide with an incidence of about 8-12/1,000 live births , Most of these defects are mild or moderate. They either do not need treatment or treatment is needed only after infancy. Other defects are severe and require early treatment in infancy, which are the primary objectives of screening, because they are at risk of adverse or irreversible outcomes as a consequence of congenital heart defects. However, about half the neonates in the nursery have no distinctive clinical signs (symptoms, abnormal murmurs or cyanosis).So it's necessary to develop a screening strategy for neonatologist and pediatrician, especially physicians in community. Screening strategy in our study consists of 7 indicators: Family history of CHD, tachypnea, heart murmurs(≥ 2 grade), cyanosis, other non-cardiac malformations,special face feature（relating to chromosomal or non-chromosomal syndromes）, subnormal Pulse Oximetry reading (Oxygen saturation of less than 95% in either limb or more than 3% difference）。The newborn babies with any of these 7 indicators positive will be considered positive-screened and echocardiography will performed.
The whole study (screening for CHDs with 7 indicators and performing the echocardiography for diagnosis) will be conducted by one single investigator (Quming Zhao from Children's Hospital of Fudan University). The new generation Pulse Oximetry has been proved to have low intraobserver and interobserver variability, but the interobserver variability in clinical evaluation (especially murmurs and cyanosis) remain unknown, the investigator will also assess the interobserver variability by comparing Quming Zhao and other two pediatricians (from the participating Hospital)(blind to each other).
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, Newborn, Pulse oximetry, Screening
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the 7 indicators for detection of all CHDs and major CHDs
Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of 7 indicators for the detection of all CHDs and major CHDs as gold standard the echocardiography.
Measured: The goldstandard for CHD diagnosis is the echocardiography performed within 1 hour from the screening completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- 6,730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoying huang, Fudan University
- Investigators
- Huang G Ying, MD PHD, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665261
- Sponsor's protocol ID
- KY2011-366-1
- Acronym
- NSCHD
- Status last verified
- Mar 2015
- First submitted
- 9 Aug 2012
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de-Wahl Granelli A, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganas L, Eriksson M, Segerdahl N, Agren A, Ekman-Joelsson BM, Sunnegardh J, Verdicchio M, Ostman-Smith I. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009 Jan 8;338:a3037. doi: 10.1136/bmj.a3037.
PubMed 19131383Ewer AK, Furmston AT, Middleton LJ, Deeks JJ, Daniels JP, Pattison HM, Powell R, Roberts TE, Barton P, Auguste P, Bhoyar A, Thangaratinam S, Tonks AM, Satodia P, Deshpande S, Kumararatne B, Sivakumar S, Mupanemunda R, Khan KS. Pulse oximetry as a screening test for congenital heart defects in newborn infants: a test accuracy study with evaluation of acceptability and cost-effectiveness. Health Technol Assess. 2012;16(2):v-xiii, 1-184. doi: 10.3310/hta16020.
PubMed 22284744Mahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, Gidding SS, Beekman RH 3rd, Grosse SD; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, and Interdisciplinary Council on Quality of Care and Outcomes Research; American Academy of Pediatrics Section on Cardiology and Cardiac Surgery, and Committee on Fetus and Newborn. Role of pulse oximetry in examining newborns for congenital heart disease: a scientific statement from the American Heart Association and American Academy of Pediatrics. Circulation. 2009 Aug 4;120(5):447-58. doi: 10.1161/CIRCULATIONAHA.109.192576. Epub 2009 Jul 6.
PubMed 19581492
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Assessment of 7 Clinical Indicators in Newborn Screening for Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01665261
- Acronym / sponsor ID
- NSCHD / KY2011-366-1
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, Newborn, Pulse oximetry, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,730 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Aug 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 test the accuracy of 7 indicators in screening congenital heart defects (CHD) in all newborns (symptomatic or asymptomatic) to determine whether these indicators could be applied in the nationwide newborn CHD screening. The investigator's hypothesis is that 7 indicators are effective in neonate CHD screening with the acceptable accuracy.
Detailed description
Congenital heart defects (CHD) are among the most common major congenital anomalies, and they occur worldwide with an incidence of about 8-12/1,000 live births , Most of these defects are mild or moderate. They either do not need treatment or treatment is needed only after infancy. Other defects are severe and require early treatment in infancy, which are the primary objectives of screening, because they are at risk of adverse or irreversible outcomes as a consequence of congenital heart defects. However, about half the neonates in the nursery have no distinctive clinical signs (symptoms, abnormal murmurs or cyanosis).So it's necessary to develop a screening strategy for neonatologist and pediatrician, especially physicians in community. Screening strategy in our study consists of 7 indicators: Family history of CHD, tachypnea, heart murmurs(≥ 2 grade), cyanosis, other non-cardiac malformations,special face feature（relating to chromosomal or non-chromosomal syndromes）, subnormal Pulse Oximetry reading (Oxygen saturation of less than 95% in either limb or more than 3% difference）。The newborn babies with any of these 7 indicators positive will be considered positive-screened and echocardiography will performed.
The whole study (screening for CHDs with 7 indicators and performing the echocardiography for diagnosis) will be conducted by one single investigator (Quming Zhao from Children's Hospital of Fudan University). The new generation Pulse Oximetry has been proved to have low intraobserver and interobserver variability, but the interobserver variability in clinical evaluation (especially murmurs and cyanosis) remain unknown, the investigator will also assess the interobserver variability by comparing Quming Zhao and other two pediatricians (from the participating Hospital)(blind to each other).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All consecutive neonates including pre-mature neonates and symptomatic neonates) will be recruited prospectively from two collaboration hospitals of the ongoing projects- "Key Clinical Research Project Sponsored by Ministry of Health Screening, evaluation and intervention of congenital heart disease in newborn infants(2010-239)"
Key inclusion criteria (2 listed)
- all consecutive live newborn infants
- between 6-72hours of age
Key exclusion criteria (3 listed)
- declining the screening;
- early discharge before the screening;
- missing
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
Diagnostic accuracy of the 7 indicators for detection of all CHDs and major CHDs
Time frame: The goldstandard for CHD diagnosis is the echocardiography performed within 1 hour from the screening completed.
Sensitivity, specificity, negative and positive predictive value, negative and positive likelihood ratio of 7 indicators for the detection of all CHDs and major CHDs as gold standard the echocardiography.
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 11 Mar 2015.
- Background: PubMed 19131383de-Wahl Granelli A, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganas L, Eriksson M, Segerdahl N, Agren A, Ekman-Joelsson BM, Sunnegardh J, Verdicchio M, Ostman-Smith I. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009 Jan 8;338:a3037. doi: 10.1136/bmj.a3037.
- Background: PubMed 22284744Ewer AK, Furmston AT, Middleton LJ, Deeks JJ, Daniels JP, Pattison HM, Powell R, Roberts TE, Barton P, Auguste P, Bhoyar A, Thangaratinam S, Tonks AM, Satodia P, Deshpande S, Kumararatne B, Sivakumar S, Mupanemunda R, Khan KS. Pulse oximetry as a screening test for congenital heart defects in newborn infants: a test accuracy study with evaluation of acceptability and cost-effectiveness. Health Technol Assess. 2012;16(2):v-xiii, 1-184. doi: 10.3310/hta16020.
- Background: PubMed 19581492Mahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, Gidding SS, Beekman RH 3rd, Grosse SD; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, and Interdisciplinary Council on Quality of Care and Outcomes Research; American Academy of Pediatrics Section on Cardiology and Cardiac Surgery, and Committee on Fetus and Newborn. Role of pulse oximetry in examining newborns for congenital heart disease: a scientific statement from the American Heart Association and American Academy of Pediatrics. Circulation. 2009 Aug 4;120(5):447-58. doi: 10.1161/CIRCULATIONAHA.109.192576. Epub 2009 Jul 6.
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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.
Huang G Ying, MD PHD study chair
Children's Hospital of Fudan University
2 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 Children's Hospital of Fudan University at 2 sites in China.
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 2 inclusion and 3 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Diagnostic accuracy of the 7 indicators for detection of all CHDs and major CHDs (time frame: The goldstandard for CHD diagnosis is the echocardiography performed within 1 hour from the screening completed.). 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 NCT01665261, which also lists 3 linked publications.
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 11 Mar 2015.