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Remifentanil in Ventilated Preterm Infants

Primary Purpose

Preterm Infants, Mechanical Ventilator Care

Status
Terminated
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
remifentanil infusion
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Infants

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

remifentanil

Arm Description

5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth

0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth

Outcomes

Primary Outcome Measures

premature infant pain profile (PIPP)
PIPP measure during tracheal suction window period ; +/- 1hr

Secondary Outcome Measures

intraventricular hemorrhage
intraventricular hemorrhage documented by sonography
pneumothorax
pneumothorax documented by X-ray or sonography
bronchopulmonary dysplasia
O2 dependency
duration of ventilator care
mechanical ventilator dependency
hospital day
days from admission to discharge from neonatal intensive care unit
time to full feeding
day of life when the baby reaches full enteral feeding, defined as a volume above 120 mL/kg/day
mortality
in-hospital death
development of adverse effects
category of adverse effects General appearance Fever or Hypothermia, Rash 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) Gastrointestinal Abdominal distension Bilious gastric remain Vomiting Bloody Stool Necrotizing Enterocolitis Renal Oliguria (U/O < 1.0cc/kg/day) Neurologic Seizure Cerebral infarction

Full Information

First Posted
August 31, 2012
Last Updated
November 18, 2015
Sponsor
Seoul National University Hospital
Collaborators
Ajou University School of Medicine, DongGuk University
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1. Study Identification

Unique Protocol Identification Number
NCT01713127
Brief Title
Remifentanil in Ventilated Preterm Infants
Official Title
Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Why Stopped
declined enrollment
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ajou University School of Medicine, DongGuk University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants, Mechanical Ventilator Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth
Arm Title
remifentanil
Arm Type
Active Comparator
Arm Description
0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth
Intervention Type
Drug
Intervention Name(s)
remifentanil infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
premature infant pain profile (PIPP)
Description
PIPP measure during tracheal suction window period ; +/- 1hr
Time Frame
24hours after remifentanil/placebo infusion
Secondary Outcome Measure Information:
Title
intraventricular hemorrhage
Description
intraventricular hemorrhage documented by sonography
Time Frame
up to 1 week of age
Title
pneumothorax
Description
pneumothorax documented by X-ray or sonography
Time Frame
up to 1 week of age
Title
bronchopulmonary dysplasia
Description
O2 dependency
Time Frame
28 days of age
Title
duration of ventilator care
Description
mechanical ventilator dependency
Time Frame
up to 4 months of age
Title
hospital day
Description
days from admission to discharge from neonatal intensive care unit
Time Frame
upto 4 months of age
Title
time to full feeding
Description
day of life when the baby reaches full enteral feeding, defined as a volume above 120 mL/kg/day
Time Frame
up to 2 months of age
Title
mortality
Description
in-hospital death
Time Frame
up to 4 months of age
Title
development of adverse effects
Description
category of adverse effects General appearance Fever or Hypothermia, Rash 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) Gastrointestinal Abdominal distension Bilious gastric remain Vomiting Bloody Stool Necrotizing Enterocolitis Renal Oliguria (U/O < 1.0cc/kg/day) Neurologic Seizure Cerebral infarction
Time Frame
from the start of remifentanil infusion to 1 hour after end of infusion

10. Eligibility

Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Children's Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Remifentanil in Ventilated Preterm Infants

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