CompletedNot Applicable

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

1,604 participantsStarted 2013-01-01

Plain-language 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.

Who can participate

Age range

0 Days – 1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The cutoff of four-limb BPs gradient to diagnose CMoA

Timeframe: at admission

Trial details

NCT IDNCT05022836

SponsorGuangdong Provincial People's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Congenital Heart Disease in Children trials