Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT00391105
Status:
COMPLETED
Last Update Posted:
2006-10-23
First Post:
2006-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2005-11'}, 'lastUpdateSubmitDate': '2006-10-19', 'studyFirstSubmitDate': '2006-10-19', 'studyFirstSubmitQcDate': '2006-10-19', 'lastUpdatePostDateStruct': {'date': '2006-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation conditions using a four point scale'}, {'measure': 'Decrease in time after interruption of sedation until the neonate be awake.'}, {'measure': 'Decrease in time after interruption of sedation until the neonate be extubated.'}], 'secondaryOutcomes': [{'measure': 'Pain and stress before and after intubation (NIPS and Comfort scores).'}, {'measure': 'Pain and stress during continuous infusion of remifentanil versus morphine during mechanical ventilation for the treatment of respiratory distress syndrome (NIPS and Comfort scores).'}]}, 'conditionsModule': {'keywords': ['intubation', 'Sedation', 'Analgesia', 'preterm neonate', 'remifentanil', 'morphine', 'respiratory distress syndrome'], 'conditions': ['Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '16238563', 'type': 'BACKGROUND', 'citation': 'Pereira e Silva Y, Gomez RS, Barbosa RF, Simoes e Silva AC. Remifentanil for sedation and analgesia in a preterm neonate with respiratory distress syndrome. Paediatr Anaesth. 2005 Nov;15(11):993-6. doi: 10.1111/j.1460-9592.2005.01666.x.'}]}, 'descriptionModule': {'briefSummary': 'In this randomised controlled study we intended to compared intubation conditions and the continuous infusion of remifentanil (n=10) and morphine (n=10) in mechanically ventilated premature neonates (28-34wk) regarding the time to be awake and, the time until extubation after interruption of the opioid administration.', 'detailedDescription': 'Intubation and mechanical ventilation are majors component of intensive care for premature neonates with respiratory distress syndrome (RDS) and is associated with physiologic, biochemical, and clinical responses indicating pain and stress in prematures. Although morphine is one of the most used drugs for premedication and for sedation and analgesia during mechanical ventilation in the treatment of RDS its pharmacological profile precludes several limitations mostly due to its much delayed onset of action what makes the drug not suitable as premedication and due to its prolonged duration of action mainly in prematures. Unlike morphine, remifentanil has an unique pharmacokinetic properties with a rapid onset of action and, a fast decrease in plasma concentration after interruption of administration due to a context-sensitive half-time of 3.2 minutes. So, it could be the ideal opioid for neonates who are especially sensitive to respiratory depression by opioids'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '60 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age between 28 and 34 wk\n* Clinical and radiological features compatible with respiratory distress syndrome that required an elective tracheal intubation and surfactant therapy.\n\nExclusion criteria:\n\n* The presence of major congenital malformations\n* Birth weigh less than 1000g\n* Previous or concurrent use of opioid for any reason (cesarean section with general anaesthesia)\n* Hemodynamic instability before the indication of tracheal intubation\n* Refuse of the parents to enroll the neonate in the study protocol'}, 'identificationModule': {'nctId': 'NCT00391105', 'briefTitle': 'Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'Comparative Study of the Use of Remifentanil Versus Morphine for Sedation and Analgesia of Premature Neonates During Mechanical Ventilation in the Treatment of Respiratory Distress Syndrome (RDS)', 'orgStudyIdInfo': {'id': 'ETIC 287/04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Remifentanil', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yerkes P Silva, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine from Federal University of Minas Gerais'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}}}}