Ignite Creation Date:
2024-05-06 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03136172
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2017-04-27
Brief Title:
Monitoring of Systemic or Organ Perfusion for Preterm Infants
Sponsor:
Inha University Hospital
Organization:
Inha University Hospital
Study Overview
Official Title:
Observational Study on Monitoring of Systemic or Organ Blood Circulation and Perfusion for Preterm Infants
Status:
COMPLETED
Status Verified Date:
2019-02
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:
To investigate biomarker reflects systemic or specific organ perfusion well we are going to the observational comparison study using several hemodynamic monitoring methods in the premature infants It includes near-infrared spectroscopy NIRS pulse oximetry with perfusion index PI and pleth variability index PVI and functional echocardiography
Detailed Description:
Hemodynamic observational comparisons will be performed in 6 episodes below on each patient
1 first 24 hours after birth
2 during red blood cell RBC transfusion from 4 hours before to 4 hours after the transfusion
3 suspicion of necrotizing enterocolitis from the suspicion point for 48 hours
4 suspicion of sepsis from the suspicion point for 48 hours
5 oligouria 1 mLkghour of urine for 48 hours
6 hypotension mean blood pressure 30 mmHg for 48 hours
1 first 24 hours after birth
2 during red blood cell RBC transfusion from 4 hours before to 4 hours after the transfusion
3 suspicion of necrotizing enterocolitis from the suspicion point for 48 hours
4 suspicion of sepsis from the suspicion point for 48 hours
5 oligouria 1 mLkghour of urine for 48 hours
6 hypotension mean blood pressure 30 mmHg for 48 hours
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