Monitoring of Systemic or Organ Perfusion for Preterm Infants

NCT03136172 | Completed

• 1 other identifier: Neoperfusion-2017
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Positive predictive value of each index on hypotension

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

  first 24 hours after birth

Study Arms (1)

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

Device: NIRS (near Infra-red spectroscopy)

Interventions

NIRS (near Infra-red spectroscopy) 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)

Also known as: Pulse oximetry, Echocardiography

Premature infant

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

premature infants with 32 weeks or less of gestational age or 1,500 g or less of birth weight

You may qualify if:

• premature infants with 32 weeks or less of gestational age or 1,500 g or less of birth weight

You may not qualify if:

• infants without the consent of their guardians

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (1)

Inha University Hospital

Incheon, 22332, South Korea

Location

MeSH Terms

Conditions

Premature Birth; Neonatal Sepsis; Oliguria; Hypotension

Interventions

Spectroscopy, Near-Infrared; Oximetry; Echocardiography

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Cardiac Imaging Techniques; Ultrasonography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Neonatology, Department of Pediatrics

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 2, 2017
• Study Start: May 8, 2017
• Primary Completion: October 1, 2018
• Study Completion: December 31, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)