Perfusion Index Variability in Respiratory Distress Syndrome

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

Detailed Description
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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.

Official Title
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Perfusion Index Variability in Preterm Infants Treated With Two Different Natural Surfactants for Respiratory Distress Syndrome

Conditions
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Poor Peripheral Perfusion

Intervention / Treatment
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* Drug: Beractant
* Drug: Poractant alfa


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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Beractant<br>Beractant;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 | Drug: Beractant<br>* 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<br>* Other names: Beractant (Survanta);|
| Active Comparator: Poractant alfa<br>Poractant 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 | Drug: Poractant alfa<br>* 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<br>* Other names: Poractant alfa (curosurf);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation | The effects of the two treatment regimens on duration of mechanical ventilation were compared | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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natural surfactants; perfusion index