Remifentanil in Ventilated Preterm Infants

Phase 1

Terminated

• Conditions: Preterm Infants; Mechanical Ventilator Care
• Interventions: Drug: remifentanil infusion; Drug: Placebo

• Registration Number: NCT01713127
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-31
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-21
• Study First Posted: 2012-10-24
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2015-11-18
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• preterm infants (<37weeks of gestational age)
• requiring ventilator care
• informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remifentanil	remifentanil infusion	0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth
Placebo	Placebo	5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth

Primary Outcome Measures

Name	Time	Method
premature infant pain profile (PIPP)	24hours after remifentanil/placebo infusion	PIPP measure during tracheal suction window period ; +/- 1hr

Secondary Outcome Measures

Name	Time	Method
pneumothorax	up to 1 week of age	pneumothorax documented by X-ray or sonography
bronchopulmonary dysplasia	28 days of age	O2 dependency
duration of ventilator care	up to 4 months of age	mechanical ventilator dependency
intraventricular hemorrhage	up to 1 week of age	intraventricular hemorrhage documented by sonography
hospital day	upto 4 months of age	days from admission to discharge from neonatal intensive care unit
development of adverse effects	from the start of remifentanil infusion to 1 hour after end of infusion	category of adverse effects; 1. General appearance Fever or Hypothermia, Rash; 2. 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); 3. Gastrointestinal Abdominal distension Bilious gastric remain Vomiting Bloody Stool Necrotizing Enterocolitis; 4. Renal Oliguria (U/O \< 1.0cc/kg/day); 5. Neurologic Seizure Cerebral infarction
time to full feeding	up to 2 months of age	day of life when the baby reaches full enteral feeding, defined as a volume above 120 mL/kg/day
mortality	up to 4 months of age	in-hospital death

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of