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Remifentanil in Ventilated Preterm Infants

This study has been terminated.
(declined enrollment)
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: November 18, 2015
Last verified: October 2012
  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
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support

Resource links provided by NLM:


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 ]
    PIPP measure during tracheal suction window period ; +/- 1hr


Secondary Outcome Measures:
  • 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


Enrollment: 12
Study Start Date: August 2012
Study Completion Date: February 2013
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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
  More Information

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01713127     History of Changes
Other Study ID Numbers: RFTN-02
12077 ( Other Identifier: Korea FDA )
Study First Received: August 31, 2012
Last Updated: November 18, 2015

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 26, 2017