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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05022836
• Other study ID #: Four-limb BPs in CMoA
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: June 25, 2021

Study information

• Verified date: August 2021
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1604
• Est. completion date: June 25, 2021
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Coarctation
• Blood Pressure
• Coarctation of Aorta
• Congenital Abnormalities
• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases
• Interrupted Aortic Arch

Intervention

Diagnostic Test:
• four-limb blood pressure measurements
Four-limb blood pressures were measured by certificated nurses at admission.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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