Remifentanil in Ventilated Preterm Infants

Seoul National University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Mechanical Ventilator Care; Preterm Infants

Treatments: Drug: Placebo; Drug: remifentanil infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01713127

RFTN-02

12077 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

remifentanil

Active Comparator group

Description:

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

Treatment:

Drug: remifentanil infusion