Monitoring of Systemic or Organ Perfusion for Preterm Infants

Completed

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

• Registration Number: NCT03136172
• Lead Sponsor: Inha University Hospital

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.

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 Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-02
• Study Start: 2017-05-08
• Primary Completion: 2018-10-01
• Study Completion: 2018-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

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

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Exclusion Criteria

• infants without the consent of their guardians

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Premature infant	NIRS (near Infra-red spectroscopy)	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

Primary Outcome Measures

Name	Time	Method
Positive predictive value of each index on hypotension	first 24 hours after birth	Positive predictive value of each index which are recorded through the monitoring machines

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of