An observational study in Congenital Heart Disease in Children, Coarctation of Aorta and Interrupted Aortic Arch, sponsored by Guangdong Provincial People's Hospital. Completed. Open to participants aged 0 Days to 1 Year. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by Guangdong Provincial People's Hospital · Observational
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.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 1,604 is above the median of 100 across 29 observational studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Guangdong Provincial People's Hospital is the lead sponsor of 237 studies on the registry; 102 are open to participants now.
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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.
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Exclusion Criteria:
Four-limb blood pressures were measured by certificated nurses at admission.
Also known as: Echocardiogram or cardiac computed tomography results were used as the gold standard.
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.
Time frame: at admission
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.
Time frame: at admission
No study locations are listed for this record.
Plan to share: Undecided
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Ran from Jan 2013 to primary completion in Dec 2019, 83 months.
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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