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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05961670

Enrollment

Registered

2023-07-27

Start date

2023-08-01

Completion date

2024-09-30

Last updated

2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Newborn

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.

Interventions

DEVICENeer Infrared Spectroscopy

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Hours to 24 Hours

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.

Design outcomes

Primary

Measure	Time frame	Description
rpSO2 before and after surfactant therapy	6 hours	brain and lung rpSO2 will be compared before and after surfactant administration

Secondary

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactManoj Biniwale, MD

Biniwale@usc.edu3234093406

Backup ContactRangasamy Ramanathan, MD

Ramanath@usc.edu3234093406

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026