Remifentanil in Ventilated Preterm Infants

Study Overview
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Brief Summary
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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

Official Title
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Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support

Conditions
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Preterm Infants, Mechanical Ventilator Care

Intervention / Treatment
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* Drug: remifentanil infusion
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preterm infants (<37weeks of gestational age) requiring ventilator care informed consent Exclusion Criteria: major anomaly 48hrs after birth requiring operation during drug infusion cord blood pH < 7.0 intraventricular hemorrhage grade III or more investigators decision

Ages Eligible for Study
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Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth | Drug: Placebo<br> <br> |
| Active Comparator: remifentanil<br>0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth | Drug: remifentanil infusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| premature infant pain profile (PIPP) | PIPP measure during tracheal suction window period ; +/- 1hr | 24hours after remifentanil/placebo infusion | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 General appearance Fever or Hypothermia, Rash Respiratory & Cardiovascular Arrhythmia Tachypnea (RR >100/min) Desaturation (SpO2 <80%) Hypotension (inotropics use or need volume challenge) Bradycardia (HR <80/min) Tachycardia (HR >200/min) Gastrointestinal Abdominal distension Bilious gastric remain Vomiting Bloody Stool Necrotizing Enterocolitis Renal Oliguria (U/O < 1.0cc/kg/day) Neurologic Seizure Cerebral infarction | from the start of remifentanil infusion to 1 hour after end of infusion |