Skip to main content
Clinical Trials/NCT05961670
NCT05961670
Not yet recruiting
Not Applicable

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

Keck School of Medicine of USC1 site in 1 country50 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome, Newborn
Sponsor
Keck School of Medicine of USC
Enrollment
50
Locations
1
Primary Endpoint
rpSO2 before and after surfactant therapy
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
September 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Manoj Biniwale

Associate Professor of Pediatrics

Keck School of Medicine of USC

Eligibility Criteria

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.

Outcomes

Primary Outcomes

rpSO2 before and after surfactant therapy

Time Frame: 6 hours

brain and lung rpSO2 will be compared before and after surfactant administration

Secondary Outcomes

  • variations on rpSO2 and rcSO2 during changes in ventilation modes(6 hours)
  • correlation between rpSO2L and SpO2/FiO2 ratio, a/APO2, and O.I(6 hours)

Study Sites (1)

Loading locations...

Similar Trials