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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03136172
Enrollment
85
Registered
2017-05-02
Start date
2017-05-08
Completion date
2018-12-31
Last updated
2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoperfusion in Newborn, Hypotension, Infant, Premature, Necrotizing Enterocolitis of Newborn, Oliguria, Sepsis Newborn

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 mL/kg/hour of urine): for 48 hours 6. hypotension (mean blood pressure \< 30 mmHg): for 48 hours

Interventions

DEVICENIRS (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)

Sponsors

Inha University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Positive predictive value of each index on hypotensionfirst 24 hours after birthPositive predictive value of each index which are recorded through the monitoring machines

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026