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?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05022836

Enrollment

1604

Registered

2021-08-26

Start date

2013-01-01

Completion date

2021-06-25

Last updated

2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Coarctation of Aorta, Congenital Heart Disease in Children, Hypoplasia of Aorta, Interrupted Aortic Arch

Keywords

Congenital Heart Disease, Coarctation of Aorta, Interrupted Aortic Arch, Hypoplasia of Aorta, Blood Pressure, screening

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.

Interventions

DIAGNOSTIC_TESTfour-limb blood pressure measurements

Four-limb blood pressures were measured by certificated nurses at admission.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Days to 1 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026