Ignite Creation Date:
2024-05-06 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05022836
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2021-08-20
Brief Title:
Four-limb Blood Pressures in Infants With High Risk of Congenital Malformation of Aorta
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
Should Four-limb Blood Pressures be Used in Infants With High Risk of Congenital Malformation of Aorta
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None