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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1604 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2021-06-25

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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four-limb blood pressure measurements

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Echocardiogram or cardiac computed tomography results were used as the gold standard.

Eligibility Criteria

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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.