Monitoring of Systemic or Organ Perfusion for Preterm Infants

Observational Study on Monitoring of Systemic or Organ Blood Circulation and 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.

Study Overview

• Status: Completed
• Conditions: Hypotension; Oliguria; Infant, Premature; Necrotizing Enterocolitis of Newborn; Sepsis Newborn; Hypoperfusion in Newborn
• Intervention / Treatment: Device: NIRS (near Infra-red spectroscopy)

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

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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: Echocardiography; Pulse oximetry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Inha University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 2, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Urological Manifestations; Gastrointestinal Diseases; Infant, Newborn, Diseases; Gastroenteritis; Urination Disorders; Intestinal Diseases; Sepsis; Enterocolitis; Enterocolitis, Necrotizing; Hypotension; Oliguria; Neonatal Sepsis
• Other Study ID Numbers: Neoperfusion-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No