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

NCT05022836 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1604

Last updated 2021-09-01

No results posted yet for this study

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

DIAGNOSTIC_TEST

four-limb blood pressure measurements

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

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Yifei Wang, MD · Guangdong Provincial People's Hospital

Eligibility

Min Age
0 Days
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2019-12-31
Completion
2021-06-25

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022836 on ClinicalTrials.gov