Perfusion Index Variability in Respiratory Distress Syndrome

Dr. Sami Ulus Children's Hospital92 enrolled

Overview

Perfusion index may vary according to type of surfactant during the treatment of respiratory distress syndrome.

Peripheral tissues of preterm infants are very sensitive for hypoperfusion, but there are rare data in the literature for peripheral perfusion after surfactant treatment. In this study the investigators aimed to compare the perfusion index (PI) variability in premature infants with respiratory distress (RDS) following instillation of one of two different natural surfactant preparations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Poor Peripheral Perfusion

Interventions

BeractantDRUG

Beractant;both initial and subsequent dosing is 100 mg/kg (4 mL/kg), which may be given every 6 hours up to four total doses

Poractant alfaDRUG

porcine lung extract, initial dosing is 200 mg/kg (2.5 mL/kg) and repeated dosing is given at 100 mg/kg (1.25 mL/kg) every 12 hours, up to maximum of two additional doses when indicated

Eligibility

Sex: ALLMin age: 1 DayMax age: 3 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * premature infants \< 32 weeks of gestational age Exclusion Criteria: * congenital malformation * Apgar scores \<3 at 5 min

Outcomes

Primary Outcomes

perfusion index

PI and oxygen saturation (SpO2) were measured by "Masimo Rainbow SET Radical-7 pulse oximeter" before and after surfactant. The effects of the two treatment regimens on PI, oxygenation and clinical outcome were compared.

Time frame: 1 week

Secondary Outcomes

Duration of mechanical ventilation

The effects of the two treatment regimens on duration of mechanical ventilation were compared

Time frame: 4 weeks

Data from ClinicalTrials.gov

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