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

• Sponsor: Keck School of Medicine of USC (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05961670
• Collaborator: Medtronic (Industry)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Newborn	Device: Neer Infrared Spectroscopy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Application of Lung Near-Infrared Spectroscopy (NIRS) During Invasive and Non-Invasive Ventilation and Pre- and Post-Surfactant Administration in Preterm Infants
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Sep 30, 2024

Outcome Measures

Primary Outcome Measures

1. rpSO2 before and after surfactant therapy [6 hours]

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

Secondary Outcome Measures

1. variations on rpSO2 and rcSO2 during changes in ventilation modes [6 hours]

   Will evaluate for variations with various ventilation modes

2. correlation between rpSO2L and SpO2/FiO2 ratio, a/APO2, and O.I [6 hours]

   Correlation will be assessed between rpSO2 and other ratios

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Hour to 24 Hours
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles General Medical Center	Los Angeles	California	United States	90033

Sponsors and Collaborators

• Keck School of Medicine of USC
• Medtronic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manoj Biniwale, Associate Professor of Pediatrics, Keck School of Medicine of USC
• ClinicalTrials.gov Identifier: NCT05961670
• Other Study ID Numbers: 13184
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn

Study Results

No Results Posted as of Jul 27, 2023