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

NCT05022836 | Completed

• 1 other identifier: Four-limb BPs in CMoA
• Study Type: observational
• Target: 1,604
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Congenital Heart Disease; Coarctation of Aorta; Interrupted Aortic Arch; Hypoplasia of Aorta; Blood Pressure; screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The accuracy of four-limb BPs measurement to predict CMoA

  at admission

Interventions

four-limb blood pressure measurements DIAGNOSTIC_TEST

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

Also known as: Echocardiogram or cardiac computed tomography results were used as the gold standard.

Eligibility Criteria

• Age: 0 Days - 1 Year
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Infants without four-limb blood pressures measurement or without echocardiogram and cardiac computed tomography results were excluded.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

MeSH Terms

Conditions

Aortic Coarctation; Heart Defects, Congenital

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Yifei Wang, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of the Neonatology Department, Principal Investigator

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 26, 2021
• Study Start: January 1, 2013
• Primary Completion: December 31, 2019
• Study Completion: June 25, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08