Effects of Bolus Surfactant Therapy on Peripheral Perfusion Index and Tissue Carbon Monoxide

Ege University

Status and phase: Completed; Phase 4

Conditions: Respiratory Distress Syndrome

Treatments: Drug: exogenous surfactant

Study type: Interventional

Funder types: Other

Identifiers

NCT01923844

surf_pi_co_1

Details and patient eligibility

About

Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature infants, which is also associated with inflammation. There are different types and doses of surfactant preparations available. With the help of new generation monitors, changes in peripheral perfusion and transcutaneous CO, a marker of inflammation, may be demonstrated.

Full description

Preterm infants with severe Respiratory Distress Syndrome (study group) were compared to preterm infants without Respiratory Distress Syndrome(control group). Infants in the study group were randomized to receive either poractantalfa or beractant.

Perfusion index (PI) and transcutaneous CO (TCO) values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.

Enrollment: 48 patients

Sex: All

Ages: Under 1 day old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age between 26 and 36 weeks
• intubated for respiratory distress syndrome

Exclusion criteria

• cardiac defects,
• hemodynamically significant patent ductusarteriosus,
• congenital pneumonia,
• early sepsis
• unstable infants in need of inotropic support.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

poractantalfa

Experimental group

Description:

preterm infants who received poractantalfa for respiratory distress syndrome

Treatment:

Drug: exogenous surfactant

beractant

Experimental group

Description:

preterm infants who received beractant for respiratory distress syndrome

Treatment:

Drug: exogenous surfactant

Control

No Intervention group

Description:

Preterm infants without respiratory distress syndrome