NCT05022836|Completed
Four-limb Blood Pressures in Infants With High Risk of Congenital Malformation of Aorta
Should Four-limb Blood Pressures be Used in Infants With High Risk of Congenital Malformation of Aorta?
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Should Four-limb Blood Pressures be Used in Infants With High Risk of Congenital Malformation of Aorta?
Sponsor study identifier
observational
1,604
0 countries
N/A
Study Start
January 1, 2013
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
June 25, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 25, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2013
Actual (reported)December 31, 2019
Actual (reported)June 25, 2021
Actual (reported)August 20, 2021
Actual (reported)August 26, 2021
Actual (reported)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.
at admission
The accuracy of four-limb BPs measurement to predict CMoA
at admission
Four-limb blood pressures were measured by certificated nurses at admission.
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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.
Yifei Wang, MD
Guangdong Provincial People's Hospital
1,604 participants (actual enrollment reported by the registry).
First Submitted
August 20, 2021
First Posted
August 26, 2021
Study Start
January 1, 2013
Actual (reported)Effects of Water and Glucose Drinks on Cardiovascular Function in Subjects With and Without Postprandial Hypotension
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Primary Completion
December 31, 2019
Actual (reported)Study Completion
June 25, 2021
Actual (reported)Last Updated
September 1, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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