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Monitoring of Systemic or Organ Perfusion for Preterm Infants

I

Inha University Hospital

Status

Completed

Conditions

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

Treatments

Device: NIRS (near Infra-red spectroscopy)

Study type

Observational

Funder types

Other

Identifiers

NCT03136172
Neoperfusion-2017

Details and patient eligibility

About

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.

Full 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

Enrollment

85 patients

Sex

All

Ages

Under 2 months old

Volunteers

No Healthy Volunteers

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

Trial design

85 participants in 1 patient group

Premature infant
Description:
premature infants with 32 weeks or less gestational age or 1,500 g or less birth weight, who born in the Inha university hospital and admit to the neonatal intensive care unit of the Inha university hospital
Treatment:
Device: NIRS (near Infra-red spectroscopy)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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