Remifentanil in Ventilated Preterm Infants

November 18, 2015 updated by: Seoul National University Hospital

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraventricular hemorrhage
Time Frame: up to 1 week of age
intraventricular hemorrhage documented by sonography
up to 1 week of age
pneumothorax
Time Frame: up to 1 week of age
pneumothorax documented by X-ray or sonography
up to 1 week of age
bronchopulmonary dysplasia
Time Frame: 28 days of age
O2 dependency
28 days of age
duration of ventilator care
Time Frame: up to 4 months of age
mechanical ventilator dependency
up to 4 months of age
hospital day
Time Frame: upto 4 months of age
days from admission to discharge from neonatal intensive care unit
upto 4 months of age
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
up to 2 months of age
mortality
Time Frame: up to 4 months of age
in-hospital death
up to 4 months of age
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
from the start of remifentanil infusion to 1 hour after end of infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ajou University School of Medicine
DongGuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

August 31, 2012

First Submitted That Met QC Criteria

October 21, 2012

First Posted (Estimate)

October 24, 2012

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 18, 2015

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFTN-02
  • 12077 (Korea FDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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