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| ID | Type | Description | Link |
|---|---|---|---|
| Surfactant trial | Other Identifier | SamiUlusCH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beractant | Active Comparator | 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 |
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| Poractant alfa | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beractant | Drug | 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 |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of mechanical ventilation | The effects of the two treatment regimens on duration of mechanical ventilation were compared | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | The effects of the two treatment regimens on mortality were compared | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dilek Dilli, Assoc Prof | Sami Ulus CH | Study Director |
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| ID | Term |
|---|---|
| C072197 | beractant |
| C068291 | poractant alfa |
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| Poractant alfa | Drug | 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 |
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