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

NCT05961670 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-07-27

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome, Newborn

Interventions

DEVICE

Neer Infrared Spectroscopy

Premature infants will be studied with brain and lung NIRS before and after surfactant administration

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Keck School of Medicine of USC

    lead OTHER

Eligibility

Min Age
1 Hour
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-06-30
Completion
2024-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05961670 on ClinicalTrials.gov