Congenital Heart Disease in ChildrenNCT05022836
Four-limb Blood Pressures in Infants With High Risk of Congenital Malformation of Aorta
An observational study of Congenital Heart Disease in Children and Coarctation of Aorta, run by Guangdong Provincial People's Hospital.
Trial summary
Pulse oximetry screening (POS) for critical congenital heart diseases (CCHD) could identify 90% of these infants. However, this approach is not designed to detect cardiac defects without hypoxemia, especially congenital malformations of aorta (CMoA). More than 60% of CMoA was late diagnosed. Read more about this study
- Who is it for?
- Ages 0 days to 1 year
- Conditions the study is for
- Congenital Heart Disease in Children, Coarctation of Aorta, Interrupted Aortic Arch
- What is being tested?
- four-limb blood pressure measurements
- How many people
- 1,604 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 25 Jun 2021
- 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 0 days to 1 year
- All sexes
- Child
Study population: Infants admitted to the Guangdong Provincial People's Hospital between January 1st, 2013 and December 31st, 2019, who were suspected as having congenital heart disease, were enrolled in the study. Four-limb BPs in infants of confirmed or suspected CCHD admitted at our hospital were prospectively collected at admission following the Pediatric Department protocol for CCHD infants in which all infants with high risk of CCHD, defined as confirmed or suspected CCHD by clinical teams, were screened by measuring four-limb BPs by certificated nurses. Suspected CCHD was defined as unreasonable low SpO2, cyanosis, murmur, suspected CHD by prenatal ultrasound or postnatal echocardiography at other hospitals, and unexplained poor cardiac output.
Who may be able to join
- Infants admitted to the Guangdong Provincial People's Hospital between January 1st, 2013 and December 31st, 2019, who were suspected as having congenital heart disease, were enrolled in the study.
Who cannot join
- Infants without four-limb blood pressures measurement or without echocardiogram and cardiac computed tomography results were excluded.
About this study
Official title: Should Four-limb Blood Pressures be Used in Infants With High Risk of Congenital Malformation of Aorta?
Pulse oximetry screening (POS) for critical congenital heart diseases (CCHD) could identify 90% of these infants. However, this approach is not designed to detect cardiac defects without hypoxemia, especially congenital malformations of aorta (CMoA). More than 60% of CMoA was late diagnosed.
Infants with CMoA were supposed to present with blood pressure (BP) gradient between four limbs. But a large sample size retrospective study of four-limb BP screening showed a negative result. The possible reason is that this study ran in population with a very low risk of CMoA. Whether four-limb BPs measurement could be used in infants with high risk of congenital malformation of aorta is still to be determined.
The investigators retrospectively collected four-limb BPs, which was prospectively measured, in infants with high risk of CMoA. These data were divided into two groups, the discovery group and the validation group. The best cutoff of four-limb BP gradient was generated by Youden Index. The BP gradients by age were analyzed. Pre-operative hypotension and post-operative hypertension were also analyzed.
- Conditions
- Congenital Heart Disease in Children, Coarctation of Aorta, Interrupted Aortic Arch, Hypoplasia of Aorta, Blood Pressure
- Being tested
- four-limb blood pressure measurements
- Keywords
- Congenital Heart Disease, Coarctation of Aorta, Interrupted Aortic Arch, Hypoplasia of Aorta, Blood Pressure, screening
- Medical subject headings
- Aortic Coarctation, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
four-limb blood pressure measurementsDiagnostic test
Also called Echocardiogram or cardiac computed tomography results were used as the gold standard.
Four-limb blood pressures were measured by certificated nurses at admission.
What is being measured
The primary outcome is the main question the study is designed to answer.
The cutoff of four-limb BPs gradient to diagnose CMoA
ROC curve and Youden Index were used in the discovery group and the validation group to spot the optimal cutoff of BP gradient.
Measured: at admission
Secondary outcomes (1)
The accuracy of four-limb BPs measurement to predict CMoA
The sensitivity, specificity, Youden index, the area under the ROC curve, likelihood ratio for positive test results, likelihood ratio for negative test results, positive predictive value, and negative predictive value were calculated.
Measured: at admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Jan 2013
- Primary completion31 Dec 2019
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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
- 1,604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yifei WANG, Guangdong Provincial People's Hospital
- Investigators
- Yifei Wang, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022836
- Sponsor's protocol ID
- Four-limb BPs in CMoA
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2021
- Last updated
- 1 Sep 2021
- Results posted
- 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 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should Four-limb Blood Pressures be Used in Infants With High Risk of Congenital Malformation of Aorta?
- ClinicalTrials.gov ID
- NCT05022836
- Acronym / sponsor ID
- Four-limb BPs in CMoA
- Conditions
- Congenital Heart Disease in Children, Coarctation of Aorta, Interrupted Aortic Arch, Hypoplasia of Aorta, Blood Pressure
- Keywords
- Congenital Heart Disease, Coarctation of Aorta, Interrupted Aortic Arch, Hypoplasia of Aorta, Blood Pressure, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,604 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 26 Aug 2021 (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.
Pulse oximetry screening (POS) for critical congenital heart diseases (CCHD) could identify 90% of these infants. However, this approach is not designed to detect cardiac defects without hypoxemia, especially congenital malformations of aorta (CMoA). More than 60% of CMoA was late diagnosed.
Infants with CMoA were supposed to present with blood pressure (BP) gradient between four limbs. But a large sample size retrospective study of four-limb BP screening showed a negative result. The possible reason is that this study ran in population with a very low risk of CMoA. Whether four-limb BPs measurement could be used in infants with high risk of congenital malformation of aorta is still to be determined.
The investigators retrospectively collected four-limb BPs, which was prospectively measured, in infants with high risk of CMoA. These data were divided into two groups, the discovery group and the validation group. The best cutoff of four-limb BP gradient was generated by Youden Index. The BP gradients by age were analyzed. Pre-operative hypotension and post-operative hypertension were also analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 days to 1 year
- Sex
- All
- Age groups
- Child
- Study population
- Infants admitted to the Guangdong Provincial People's Hospital between January 1st, 2013 and December 31st, 2019, who were suspected as having congenital heart disease, were enrolled in the study. Four-limb BPs in infants of confirmed or suspected CCHD admitted at our hospital were prospectively collected at admission following the Pediatric Department protocol for CCHD infants in which all infants with high risk of CCHD, defined as confirmed or suspected CCHD by clinical teams, were screened by measuring four-limb BPs by certificated nurses. Suspected CCHD was defined as unreasonable low SpO2, cyanosis, murmur, suspected CHD by prenatal ultrasound or postnatal echocardiography at other hospitals, and unexplained poor cardiac output.
Key inclusion criteria (1 listed)
- Infants admitted to the Guangdong Provincial People's Hospital between January 1st, 2013 and December 31st, 2019, who were suspected as having congenital heart disease, were enrolled in the study.
Key exclusion criteria (1 listed)
- Infants without four-limb blood pressures measurement or without echocardiogram and cardiac computed tomography results were excluded.
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 |
|---|---|---|
| four-limb blood pressure measurementsAlso: Echocardiogram or cardiac computed tomography results were used as the gold standard.Four-limb blood pressures were measured by certificated nurses at admission. | Diagnostic test | – |
Primary outcome
The cutoff of four-limb BPs gradient to diagnose CMoA
Time frame: at admission
ROC curve and Youden Index were used in the discovery group and the validation group to spot the optimal cutoff of BP gradient.
1 secondary outcome
The accuracy of four-limb BPs measurement to predict CMoA
Time frame: at admission
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 1 Sep 2021.
- 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.
Yifei Wang, MD principal investigator
Guangdong Provincial People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease in Children and Coarctation of Aorta, run by Guangdong Provincial People's Hospital.
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 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The cutoff of four-limb BPs gradient to diagnose CMoA (time frame: at admission). 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 1 Sep 2021.