Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.

University of Florida

Status: Completed

Conditions: Hemodynamic Instability; Premature Infant; Patent Ductus Arteriosus

Treatments: Device: Resonance Raman Spectroscopy (RRS)

Study type: Observational

Funder types: Other

Identifiers

NCT03277768

IRB201601508

Details and patient eligibility

About

The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at < 30 weeks of gestation. The primary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in premature infants with PDA in comparison to infants without PDA. The secondary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse events.

Enrollment: 55 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants < 30 weeks estimated gestational age

Exclusion criteria

• Infants with major congenital anomalies
• Infants >34 weeks post-menstrual age

Trial design

55 participants in 2 patient groups

Control Group -Patent Ductus Arteriosus Absent

Treatment:

Device: Resonance Raman Spectroscopy (RRS)

Study Group - Patent Ductus Arteriosus Present

Treatment:

Device: Resonance Raman Spectroscopy (RRS)