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| ID | Type | Description | Link |
|---|---|---|---|
| 12077 | Other Identifier | Korea FDA |
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declined enrollment
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| Name | Class |
|---|---|
| Ajou University School of Medicine | OTHER |
| DongGuk University | OTHER |
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The purpose of this study is to evaluate efficacy of remifentanil in preterm infants during ventilator care with remifentanil and to analyze pharmacokinetics in preterm infants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth |
|
| remifentanil | Active Comparator | 0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remifentanil infusion | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| premature infant pain profile (PIPP) | PIPP measure during tracheal suction window period ; +/- 1hr | 24hours after remifentanil/placebo infusion |
| Measure | Description | Time Frame |
|---|---|---|
| intraventricular hemorrhage | intraventricular hemorrhage documented by sonography | up to 1 week of age |
| pneumothorax | pneumothorax documented by X-ray or sonography |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Children's Hospital | Seoul | 110-744 | South Korea |
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|
| up to 1 week of age |
| bronchopulmonary dysplasia | O2 dependency | 28 days of age |
| duration of ventilator care | mechanical ventilator dependency | up to 4 months of age |
| hospital day | days from admission to discharge from neonatal intensive care unit | upto 4 months of age |
| time to full feeding | day of life when the baby reaches full enteral feeding, defined as a volume above 120 mL/kg/day | up to 2 months of age |
| mortality | in-hospital death | up to 4 months of age |
| development of adverse effects | category of adverse effects
| from the start of remifentanil infusion to 1 hour after end of infusion |