Monitoring of Systemic or Organ Perfusion for Preterm Infants

NCT ID: NCT03136172

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-08

Study Completion Date

2018-12-31

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Premature infant

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

NIRS (near Infra-red spectroscopy)

Intervention Type DEVICE

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)

Interventions

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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)

Intervention Type DEVICE

Other Intervention Names

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Pulse oximetry Echocardiography

Eligibility Criteria

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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
Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inha University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Juyoung Lee

Division of Neonatology, Department of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Inha University Hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Neoperfusion-2017

Identifier Type: -

Identifier Source: org_study_id

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