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Remifentanil in Ventilated Preterm Infants

This study has been terminated.
(declined enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01713127
First Posted: October 24, 2012
Last Update Posted: November 20, 2015
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.
Collaborators:
Ajou University School of Medicine
DongGuk University
Information provided by (Responsible Party):
Seoul National University Hospital
August 31, 2012
October 24, 2012
November 20, 2015
August 2012
February 2013   (Final data collection date for primary outcome measure)
premature infant pain profile (PIPP) [ Time Frame: 24hours after remifentanil/placebo infusion ]
PIPP measure during tracheal suction window period ; +/- 1hr
premature infant pain profile (PIPP) [ Time Frame: 24, 48, 72 hours after remifentanil/placebo infusion ]
PIPP measure during tracheal suction window period ; +/- 1hr
Complete list of historical versions of study NCT01713127 on ClinicalTrials.gov Archive Site
  • intraventricular hemorrhage [ Time Frame: up to 1 week of age ]
    intraventricular hemorrhage documented by sonography
  • pneumothorax [ Time Frame: up to 1 week of age ]
    pneumothorax documented by X-ray or sonography
  • bronchopulmonary dysplasia [ Time Frame: 28 days of age ]
    O2 dependency
  • duration of ventilator care [ Time Frame: up to 4 months of age ]
    mechanical ventilator dependency
  • hospital day [ Time Frame: upto 4 months of age ]
    days from admission to discharge from neonatal intensive care unit
  • 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
  • mortality [ Time Frame: up to 4 months of age ]
    in-hospital death
  • 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
Same as current
Not Provided
Not Provided
 
Remifentanil in Ventilated Preterm Infants
Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support
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
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
  • Preterm Infants
  • Mechanical Ventilator Care
  • Drug: remifentanil infusion
  • Drug: Placebo
  • Placebo Comparator: Placebo
    5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth
    Intervention: Drug: Placebo
  • Active Comparator: remifentanil
    0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth
    Intervention: Drug: remifentanil infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 48 Hours   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01713127
RFTN-02
12077 ( Other Identifier: Korea FDA )
Yes
Not Provided
Not Provided
Seoul National University Hospital
Seoul National University Hospital
  • Ajou University School of Medicine
  • DongGuk University
Not Provided
Seoul National University Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP