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NCT03136172 Clinical Trial

Monitoring of Systemic or Organ Perfusion for Preterm Infants

Hypotension Clinical Trial

Official title:
Observational Study on Monitoring of Systemic or Organ Blood Circulation and Perfusion for Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03136172
Other study ID # Neoperfusion-2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 8, 2017
Est. completion date December 31, 2018

Study information
Verified date February 2019
Source Inha University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 mL/kg/hour of urine): for 48 hours

6. hypotension (mean blood pressure < 30 mmHg): for 48 hours

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date December 31, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Months
Eligibility Inclusion Criteria:

- premature infants with 32 weeks or less of gestational age or 1,500 g or less of birth weight

Exclusion Criteria:

- infants without the consent of their guardians

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• NIRS (near Infra-red spectroscopy)
NIRS, INVOS 5100 cerebral/somatic oximeter monitor (Somanetics Corp, Troy, Michigan, USA) Radical-7 pulse oximeter (Masimo Corp, Irvine, CA, USA) Echocardiography (Phillips HD 15 Ultrasound system, CA, USA)

Locations
Country Name City State
Korea, Republic of Inha University Hospital Incheon

Sponsors (1)
Lead Sponsor Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Positive predictive value of each index on hypotension Positive predictive value of each index which are recorded through the monitoring machines first 24 hours after birth
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