Clinical Trial: Monitoring of Systemic or Organ Perfusion for Preterm Infants

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

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 Summary:

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

Sponsor: Inha University Hospital

Current Primary Outcome: Positive predictive value of each index on hypotension [ Time Frame: first 24 hours after birth ]

Positive predictive value of each index which are recorded through the monitoring machines


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Inha University Hospital

Dates:
Date Received: April 27, 2017
Date Started: May 2017
Date Completion: February 2018
Last Updated: April 27, 2017
Last Verified: April 2017