Monitoring of Systemic or Organ Perfusion for Preterm Infants

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.

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Key information

Conditions

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

Age range

Up to 2 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Inha University Hospital

Incheon, 22332, South Korea

About this study

Hemodynamic observational comparisons will be performed in 6 episodes below on each patient.

first 24 hours after birth
during red blood cell (RBC) transfusion: from 4 hours before to 4 hours after the transfusion
suspicion of necrotizing enterocolitis: from the suspicion point for 48 hours
suspicion of sepsis: from the suspicion point for 48 hours
oligouria (< 1 mL/kg/hour of urine): for 48 hours
hypotension (mean blood pressure < 30 mmHg): for 48 hours

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIRS (near Infra-red spectroscopy)

Device

NIRS, INVOS 5100 cerebral/somatic oximeter monitor (Somanetics Corp, Troy, Michigan, USA)
Radical-7 pulse oximeter (Masimo Corp, Irvine, CA, USA)
Echocardiography (Phillips HD 15 Ultrasound system, CA, USA)

Other names: Pulse oximetry, Echocardiography

Primary outcomes

Positive predictive value of each index on hypotension

Time frame: first 24 hours after birth

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

Sponsors and collaborators

Lead sponsor

Inha University Hospital

Other

Registry information

Official study title

Observational Study on Monitoring of Systemic or Organ Blood Circulation and Perfusion for Preterm Infants

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: May 2, 2017
Registry last updated: Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed