Remifentanil in Ventilated Preterm Infants

Preterm Infants Clinical Trial

Official title:

Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01713127
• Other study ID #: RFTN-02
• Secondary ID: 12077
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 31, 2012
• Last updated: November 18, 2015
• Start date: August 2012
• Est. completion date: February 2013

Study information

• Verified date: October 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mechanical Ventilator Care
• Premature Birth
• Preterm Infants

Intervention

Drug:
• remifentanil infusion

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ajou University School of Medicine, DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	premature infant pain profile (PIPP)	PIPP measure during tracheal suction window period ; +/- 1hr	24hours after remifentanil/placebo infusion	No
Secondary	intraventricular hemorrhage	intraventricular hemorrhage documented by sonography	up to 1 week of age	No
Secondary	pneumothorax	pneumothorax documented by X-ray or sonography	up to 1 week of age	No
Secondary	bronchopulmonary dysplasia	O2 dependency	28 days of age	No
Secondary	duration of ventilator care	mechanical ventilator dependency	up to 4 months of age	No
Secondary	hospital day	days from admission to discharge from neonatal intensive care unit	upto 4 months of age	No
Secondary	time to full feeding	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	No
Secondary	mortality	in-hospital death	up to 4 months of age	No
Secondary	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	from the start of remifentanil infusion to 1 hour after end of infusion	Yes