NCT01713127

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 20, 2015

Status Verified

October 1, 2012

Enrollment Period

6 months

First QC Date

August 31, 2012

Last Update Submit

November 18, 2015

Conditions

Preterm InfantsMechanical Ventilator Care

Outcome Measures

Primary Outcomes (1)

  • premature infant pain profile (PIPP)

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

    24hours after remifentanil/placebo infusion

Secondary Outcomes (8)

  • intraventricular hemorrhage

    up to 1 week of age

  • pneumothorax

    up to 1 week of age

  • bronchopulmonary dysplasia

    28 days of age

  • duration of ventilator care

    up to 4 months of age

  • hospital day

    upto 4 months of age

  • +3 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

remifentanil

ACTIVE COMPARATOR

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

Drug: remifentanil infusion

Interventions

remifentanil infusionDRUG
remifentanil
PlaceboDRUG
Placebo

Eligibility Criteria

AgeUp to 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • preterm infants (\<37weeks of gestational age)
  • requiring ventilator care
  • informed consent

You may not qualify if:

  • major anomaly
  • hrs after birth
  • requiring operation during drug infusion
  • cord blood pH \< 7.0
  • intraventricular hemorrhage grade III or more
  • investigators decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Children's Hospital

Seoul, 110-744, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2012

First Posted

October 24, 2012

Study Start

August 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 20, 2015

Record last verified: 2012-10

Locations

KR(1)