NCT05961670

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Keck School of Medicine of USC · Academic / Other
• Sex: All
• Age: 1 Hour – 24 Hours
• Healthy volunteers: —

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

Type	Name	Description
DEVICE	Neer Infrared Spectroscopy	Premature infants will be studied with brain and lung NIRS before and after surfactant administration

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-06-30
• Completion: 2024-09-30
• First posted: 2023-07-27
• Last updated: 2023-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study