Application of Lung Near-Infrared Spectroscopy (NIRS) in Preterm Infants
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedJuly 27, 2023
July 1, 2023
11 months
July 18, 2023
July 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
rpSO2 before and after surfactant therapy
brain and lung rpSO2 will be compared before and after surfactant administration
6 hours
Secondary Outcomes (2)
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
Interventions
Premature infants will be studied with brain and lung NIRS before and after surfactant administration
Eligibility Criteria
Inborn premature infants
You may qualify if:
- 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.
You may not qualify if:
- Neonates with no need for respiratory support/Surfactant. Neonates with congenital malformations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Keck School of Medicine of USClead
- Medtroniccollaborator
Study Sites (1)
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
July 18, 2023
First Posted
July 27, 2023
Study Start
August 1, 2023
Primary Completion
June 30, 2024
Study Completion
September 30, 2024
Last Updated
July 27, 2023
Record last verified: 2023-07