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

Not yet recruiting

• Conditions: Respiratory Distress Syndrome, Newborn

• Registration Number: NCT05961670
• Lead Sponsor: Keck School of Medicine of USC

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-18
• Last Update Submitted: 2023-07-18
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Study Start: 2023-08-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rpSO2 before and after surfactant therapy	6 hours	brain and lung rpSO2 will be compared before and after surfactant administration

Secondary Outcome Measures

Name	Time	Method
variations on rpSO2 and rcSO2 during changes in ventilation modes	6 hours	Will evaluate for variations with various ventilation modes
correlation between rpSO2L and SpO2/FiO2 ratio, a/APO2, and O.I	6 hours	Correlation will be assessed between rpSO2 and other ratios

Trial Locations

Locations (1)

Los Angeles General Medical Center; 🇺🇸 Los Angeles, California, United States