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Completed

NCT Number: NCT05022836

Four-limb Blood Pressures 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.

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Key information

Conditions

Congenital Heart Disease in Children Aortic Coarctation Blood Pressure Cardiovascular Abnormalities Cardiovascular Diseases Coarctation of Aorta Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hypoplasia of Aorta Interrupted Aortic Arch

Age range

0 day–1 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

four-limb blood pressure measurements

Diagnostic Test

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

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

Primary outcomes

  1. The cutoff of four-limb BPs gradient to diagnose CMoA

    Time frame: at admission

    ROC curve and Youden Index were used in the discovery group and the validation group to spot the optimal cutoff of BP gradient.

Secondary outcomes

  1. The accuracy of four-limb BPs measurement to predict CMoA

    Time frame: at admission

    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.

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2021
First posted
Aug 26, 2021
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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