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NCT05961670 Clinical Trial

Application of Lung Near-Infrared Spectroscopy (NIRS) in Preterm Infants

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:
Application of Lung Near-Infrared Spectroscopy (NIRS) During Invasive and Non-Invasive Ventilation and Pre- and Post-Surfactant Administration in Preterm Infants

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05961670
Other study ID # 13184
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date September 30, 2024

Study information
Verified date July 2023
Source Keck School of Medicine of USC
Contact Manoj Biniwale, MD
Phone 3234093406
Email Biniwale@usc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Premature infants are more likely to develop hypoxemia after birth often requiring invasive and Non-Invasive Mechanical ventilation and surfactant therapy to improve alveolar gas exchange and oxygen transport. Near-infrared spectroscopy (NIRS) has been used to detect pulmonary regional oxygen saturation (rpSO 2 ) as well as cerebral regional oxygen saturation (rcSO2 ) and evaluate the oxygenation state of the lung and brain. This is a prospective observational study to evaluate utility of rpSO2 and compare it with rcSO2 in preterm infants born between 23-32 weeks of gestation receiving noninvasive ventilation and surfactant treatment. Enrolled patients will be continuously studied with placement of NIRS monitor using cerebral sensor (INVOS™) for 6 hrs and 15 min before and after surfactant administration. Pulmonary regional oxygen saturation (rpSO2) with a sampling interval of 6 s will be followed for 6hrs.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date September 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers
Gender All
Age group 1 Hour to 24 Hours
Eligibility Inclusion Criteria: Infants born between 23-32 weeks of gestation admitted to the Neonatal Intensive Care Unit with respiratory distress receiving non-invasive ventilation and requiring Surfactant Replacement Therapy. Exclusion Criteria: Neonates with no need for respiratory support/Surfactant. Neonates with congenital malformations.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Neer Infrared Spectroscopy
Premature infants will be studied with brain and lung NIRS before and after surfactant administration

Locations
Country Name City State
United States Los Angeles General Medical Center Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
Keck School of Medicine of USC Medtronic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary rpSO2 before and after surfactant therapy brain and lung rpSO2 will be compared before and after surfactant administration 6 hours
Secondary variations on rpSO2 and rcSO2 during changes in ventilation modes Will evaluate for variations with various ventilation modes 6 hours
Secondary correlation between rpSO2L and SpO2/FiO2 ratio, a/APO2, and O.I Correlation will be assessed between rpSO2 and other ratios 6 hours
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