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Remifentanil in Ventilated Preterm Infants

This study is currently recruiting participants.
Verified October 2012 by Seoul National University Hospital
Sponsor:
Collaborators:
Ajou University School of Medicine
DongGuk University
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01713127
First received: August 31, 2012
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Preterm Infants
Mechanical Ventilator Care
 Drug: remifentanil infusion
Drug: Placebo
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • premature infant pain profile (PIPP) [ Time Frame: 24hours after remifentanil/placebo infusion ] [ Designated as safety issue: No ]
    PIPP measure during tracheal suction window period ; +/- 1hr


Secondary Outcome Measures:
  • intraventricular hemorrhage [ Time Frame: up to 1 week of age ] [ Designated as safety issue: No ]
    intraventricular hemorrhage documented by sonography

  • pneumothorax [ Time Frame: up to 1 week of age ] [ Designated as safety issue: No ]
    pneumothorax documented by X-ray or sonography

  • bronchopulmonary dysplasia [ Time Frame: 28 days of age ] [ Designated as safety issue: No ]
    O2 dependency

  • duration of ventilator care [ Time Frame: up to 4 months of age ] [ Designated as safety issue: No ]
    mechanical ventilator dependency

  • hospital day [ Time Frame: upto 4 months of age ] [ Designated as safety issue: No ]
    days from admission to discharge from neonatal intensive care unit

  • time to full feeding [ Time Frame: up to 2 months of age ] [ Designated as safety issue: No ]
    day of life when the baby reaches full enteral feeding, defined as a volume above 120 mL/kg/day

  • mortality [ Time Frame: up to 4 months of age ] [ Designated as safety issue: No ]
    in-hospital death

  • development of adverse effects [ Time Frame: from the start of remifentanil infusion to 1 hour after end of infusion ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 41
Study Start Date: August 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth
 Drug: Placebo
Active Comparator: remifentanil
0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth
 Drug: remifentanil infusion

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713127

Contacts
Contact: Han-Suk Kim, MD,PhD 82-2-2072-1696 kimhans@snu.ac.kr
Contact: Seung Han Shin, MD 82-2-2072-0647 revival421@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Children's Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Han-Suk Kim, MD, PhD     82-2-2072-1696     kimhans@snu.ac.kr    
Contact: Seung Han Shin, MD     82-2-2072-0647     revival421@snu.ac.kr    
Principal Investigator: Han-Suk Kim Kim, MD, PhD            
Sponsors and Collaborators
Seoul National University Hospital
Ajou University School of Medicine
DongGuk University
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01713127     History of Changes
Other Study ID Numbers: RFTN-02, 12077
Study First Received: August 31, 2012
Last Updated: October 26, 2012
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 19, 2013