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

K

Keck School of Medicine of USC

Status

Not yet enrolling

Conditions

Respiratory Distress Syndrome, Newborn

Treatments

Device: Neer Infrared Spectroscopy

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

1 to 24 hours old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Central trial contact

Manoj Biniwale, MD; Rangasamy Ramanathan, MD

Data sourced from clinicaltrials.gov

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