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

Sponsor

Guangdong Provincial People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05022836

Collaborator

(none)

1,604

Enrollment

101.7

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease in Children Coarctation of Aorta Interrupted Aortic Arch Hypoplasia of Aorta Blood Pressure	Diagnostic Test: four-limb blood pressure measurements

Study Design

Study Type:

Observational

Actual Enrollment :

1604 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Should Four-limb Blood Pressures be Used in Infants With High Risk of Congenital Malformation of Aorta?

Actual Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Jun 25, 2021

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days to 1 Year

Sexes Eligible for Study:

All

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.