Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-29 @ 11:21 PM
Study NCT ID:
NCT01713127
Status:
TERMINATED
Last Update Posted:
2015-11-20
First Post:
2012-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remifentanil in Ventilated Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'declined enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-18', 'studyFirstSubmitDate': '2012-08-31', 'studyFirstSubmitQcDate': '2012-10-21', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'premature infant pain profile (PIPP)', 'timeFrame': '24hours after remifentanil/placebo infusion', 'description': 'PIPP measure during tracheal suction window period ; +/- 1hr'}], 'secondaryOutcomes': [{'measure': 'intraventricular hemorrhage', 'timeFrame': 'up to 1 week of age', 'description': 'intraventricular hemorrhage documented by sonography'}, {'measure': 'pneumothorax', 'timeFrame': 'up to 1 week of age', 'description': 'pneumothorax documented by X-ray or sonography'}, {'measure': 'bronchopulmonary dysplasia', 'timeFrame': '28 days of age', 'description': 'O2 dependency'}, {'measure': 'duration of ventilator care', 'timeFrame': 'up to 4 months of age', 'description': 'mechanical ventilator dependency'}, {'measure': 'hospital day', 'timeFrame': 'upto 4 months of age', 'description': 'days from admission to discharge from neonatal intensive care unit'}, {'measure': 'time to full feeding', 'timeFrame': 'up to 2 months of age', 'description': 'day of life when the baby reaches full enteral feeding, defined as a volume above 120 mL/kg/day'}, {'measure': 'mortality', 'timeFrame': 'up to 4 months of age', 'description': 'in-hospital death'}, {'measure': 'development of adverse effects', 'timeFrame': 'from the start of remifentanil infusion to 1 hour after end of infusion', 'description': 'category of adverse effects\n\n1. General appearance Fever or Hypothermia, Rash\n2. 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)\n3. Gastrointestinal Abdominal distension Bilious gastric remain Vomiting Bloody Stool Necrotizing Enterocolitis\n4. Renal Oliguria (U/O \\< 1.0cc/kg/day)\n5. Neurologic Seizure Cerebral infarction'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Preterm Infants', 'Mechanical Ventilator Care']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infants (\\<37weeks of gestational age)\n* requiring ventilator care\n* informed consent\n\nExclusion Criteria:\n\n* major anomaly\n* 48hrs after birth\n* requiring operation during drug infusion\n* cord blood pH \\< 7.0\n* intraventricular hemorrhage grade III or more\n* investigators decision'}, 'identificationModule': {'nctId': 'NCT01713127', 'briefTitle': 'Remifentanil in Ventilated Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Efficacy and Safety of Remifentanil in Preterm Infants Who Require Ventilator Support', 'orgStudyIdInfo': {'id': 'RFTN-02'}, 'secondaryIdInfos': [{'id': '12077', 'type': 'OTHER', 'domain': 'Korea FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '5% dextrose infusion for 72 hours during ventilator care start within 48 hours after birth', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'remifentanil', 'description': '0.1mcg/kg/min remifentanil infusion for 72 hours during ventilator care start within 48 hours after birth', 'interventionNames': ['Drug: remifentanil infusion']}], 'interventions': [{'name': 'remifentanil infusion', 'type': 'DRUG', 'armGroupLabels': ['remifentanil']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul National University Children's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, {'name': 'DongGuk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}