Trials / Completed
CompletedNCT03136172
Monitoring of Systemic or Organ Perfusion for Preterm Infants
Observational Study on Monitoring of Systemic or Organ Blood Circulation and Perfusion for Preterm Infants
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 85 (actual)
- Sponsor
- Inha University Hospital · Academic / Other
- Sex
- All
- Age
- 2 Months
- Healthy volunteers
- Not accepted
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 mL/kg/hour of urine): for 48 hours 6. hypotension (mean blood pressure \< 30 mmHg): for 48 hours
Conditions
- Infant, Premature
- Hypoperfusion in Newborn
- Necrotizing Enterocolitis of Newborn
- Sepsis Newborn
- Oliguria
- Hypotension
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NIRS (near Infra-red spectroscopy) | 1. NIRS, INVOS 5100 cerebral/somatic oximeter monitor (Somanetics Corp, Troy, Michigan, USA) 2. Radical-7 pulse oximeter (Masimo Corp, Irvine, CA, USA) 3. Echocardiography (Phillips HD 15 Ultrasound system, CA, USA) |
Timeline
- Start date
- 2017-05-08
- Primary completion
- 2018-10-01
- Completion
- 2018-12-31
- First posted
- 2017-05-02
- Last updated
- 2019-02-27
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03136172. Inclusion in this directory is not an endorsement.