Four-limb Blood Pressures in Infants With High Risk of Congenital Malformation of Aorta

Completed

• Conditions: Hypoplasia of Aorta; Blood Pressure; Interrupted Aortic Arch; Congenital Heart Disease in Children; Coarctation of Aorta

• Registration Number: NCT05022836
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2021-06-25
• Status Verified: 2021-08
• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-26
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1604

Inclusion Criteria

• 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.

Exclusion Criteria

• Infants without four-limb blood pressures measurement or without echocardiogram and cardiac computed tomography results were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The cutoff of four-limb BPs gradient to diagnose CMoA	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.

Secondary Outcome Measures

Name	Time	Method
The accuracy of four-limb BPs measurement to predict CMoA	at admission	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.