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?

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Congenital Heart Disease in Children; Coarctation of Aorta; Interrupted Aortic Arch; Hypoplasia of Aorta
• Intervention / Treatment: Diagnostic test: four-limb blood pressure measurements

• Study Type: Observational
• Enrollment (Actual): 1604

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 year (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accuracy of four-limb BPs measurement to predict CMoA	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.	at admission

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Yifei Wang, MD, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): June 25, 2021

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; screening; Blood Pressure; Coarctation of Aorta; Interrupted Aortic Arch; Hypoplasia of Aorta
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Heart Defects, Congenital; Aortic Coarctation
• Other Study ID Numbers: Four-limb BPs in CMoA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No