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Remifentanil in Ventilated Preterm Infants

NCT ID: NCT01713127

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Preterm Infants Mechanical Ventilator Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

remifentanil

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

Group Type ACTIVE_COMPARATOR

remifentanil infusion

Intervention Type DRUG

Interventions

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remifentanil infusion

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role collaborator

DongGuk University

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Children's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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12077

Identifier Type: OTHER

Identifier Source: secondary_id

RFTN-02

Identifier Type: -

Identifier Source: org_study_id