NCT05022836

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
• Phase: —
• Study type: Observational
• Enrollment: 1,604 (actual)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 0 Days – 1 Year
• Healthy volunteers: —

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	four-limb blood pressure measurements	Four-limb blood pressures were measured by certificated nurses at admission.

Timeline

• Start date: 2013-01-01
• Primary completion: 2019-12-31
• Completion: 2021-06-25
• First posted: 2021-08-26
• Last updated: 2021-09-01