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Remifentanil in Ventilated Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01713127
Recruitment Status : Terminated (declined enrollment)
First Posted : October 24, 2012
Last Update Posted : November 20, 2015
Ajou University School of Medicine
DongGuk University
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Preterm Infants Mechanical Ventilator Care Drug: remifentanil infusion Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support
Study Start Date : August 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. premature infant pain profile (PIPP) [ Time Frame: 24hours after remifentanil/placebo infusion ]
    PIPP measure during tracheal suction window period ; +/- 1hr

Secondary Outcome Measures :
  1. intraventricular hemorrhage [ Time Frame: up to 1 week of age ]
    intraventricular hemorrhage documented by sonography

  2. pneumothorax [ Time Frame: up to 1 week of age ]
    pneumothorax documented by X-ray or sonography

  3. bronchopulmonary dysplasia [ Time Frame: 28 days of age ]
    O2 dependency

  4. duration of ventilator care [ Time Frame: up to 4 months of age ]
    mechanical ventilator dependency

  5. hospital day [ Time Frame: upto 4 months of age ]
    days from admission to discharge from neonatal intensive care unit

  6. time to full feeding [ Time Frame: 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

  7. mortality [ Time Frame: up to 4 months of age ]
    in-hospital death

  8. development of adverse effects [ Time Frame: 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

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01713127

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Korea, Republic of
Seoul National University Children's Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Ajou University School of Medicine
DongGuk University

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Responsible Party: Seoul National University Hospital Identifier: NCT01713127     History of Changes
Other Study ID Numbers: RFTN-02
12077 ( Other Identifier: Korea FDA )
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: October 2012

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents