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Perfusion Index Variability in Respiratory Distress Syndrome

Not Applicable
Completed
Conditions
Poor Peripheral Perfusion
Interventions
Registration Number
NCT01852461
Lead Sponsor
Dr. Sami Ulus Children's Hospital
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
92
Inclusion Criteria
  • premature infants < 32 weeks of gestational age
Exclusion Criteria
  • congenital malformation
  • Apgar scores <3 at 5 min

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BeractantBeractantBeractant;bovine lung extract; 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 alfaPoractant alfaPoractant alfa; 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
Primary Outcome Measures
NameTimeMethod
perfusion index1 week

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.

Secondary Outcome Measures
NameTimeMethod
Duration of mechanical ventilation4 weeks

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

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