Remifentanil in Ventilated Preterm Infants

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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01713127

Enrollment

Registered

2012-10-24

Start date

2012-08-31

Completion date

2013-02-28

Last updated

2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants, Mechanical Ventilator Care

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

Interventions

DRUGremifentanil infusion

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

No minimum to 48 Hours

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

Design outcomes

Primary

Measure	Time frame	Description
premature infant pain profile (PIPP)	24hours after remifentanil/placebo infusion	PIPP measure during tracheal suction window period ; +/- 1hr

Secondary

Measure	Time frame	Description
pneumothorax	up to 1 week of age	pneumothorax documented by X-ray or sonography
bronchopulmonary dysplasia	28 days of age	O2 dependency
duration of ventilator care	up to 4 months of age	mechanical ventilator dependency
intraventricular hemorrhage	up to 1 week of age	intraventricular hemorrhage documented by sonography
time to full feeding	up to 2 months of age	day of life when the baby reaches full enteral feeding, defined as a volume above 120 mL/kg/day
mortality	up to 4 months of age	in-hospital death
development of adverse effects	from the start of remifentanil infusion to 1 hour after end of infusion	category of adverse effects 1. General appearance Fever or Hypothermia, Rash 2. 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) 3. Gastrointestinal Abdominal distension Bilious gastric remain Vomiting Bloody Stool Necrotizing Enterocolitis 4. Renal Oliguria (U/O \< 1.0cc/kg/day) 5. Neurologic Seizure Cerebral infarction
hospital day	upto 4 months of age	days from admission to discharge from neonatal intensive care unit

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026