Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-26 @ 7:12 PM
Study NCT ID:
NCT00761059
Status:
UNKNOWN
Last Update Posted:
2009-02-25
First Post:
2008-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of Oral Glucose in Preterm Neonates During Suctioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'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'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-24', 'studyFirstSubmitDate': '2008-09-24', 'studyFirstSubmitQcDate': '2008-09-25', 'lastUpdatePostDateStruct': {'date': '2009-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The PIPP-Score, a validated pain-score, is used to measure the patient's pain", 'timeFrame': 'during nasopharyngeal suctioning'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['analgesia', 'infant, premature', 'glucose', 'nasopharyngeal suctioning'], 'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': "Nasopharyngeal suctioning is a painful procedure that often becomes necessary in the care of preterm infants under CPAP therapy several times a day. Since the use of analgetic and sedative drugs is accompanied with multiple side effects these are usually being avoided. Glucose 20% has been shown to have an analgesic effect when administered to preterm infants previous to some painful procedures (i.e blood sampling).\n\nIn this clinical trial the efficacy of orally administered Glucose 20% for relieving the procedural pain of nasopharyngeal suctioning is tested. The investigators' study has a cross-over design and is to include 40 patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Preterm newborns (\\>1500g birth weight) up to a gestational age of 36+6 weeks\n* CPAP respiratory therapy\n* Parents' given written consent\n\nExclusion Criteria:\n\n* Diseases complicating neuromuscular evaluation.\n* Drug abuse by the mother\n* Administration of other analgetic or sedative drugs within the previous 48h.\n* Participation in another interventional clinical trial within 4 weeks before the beginning of this trial."}, 'identificationModule': {'nctId': 'NCT00761059', 'acronym': 'Glucose FG', 'briefTitle': 'Analgesic Efficacy of Oral Glucose in Preterm Neonates During Suctioning', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Prospective, Placebo-Controlled Blinded Clinical Trial to Study the Efficacy of Orally Administered Glucose 20% for Relieving Pain During Nasopharyngeal Suctioning in Preterm Infants > 1500g Under CPAP-Therapy', 'orgStudyIdInfo': {'id': 'Uni-Koeln-905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glucose 20%', 'interventionNames': ['Drug: Glucose 20%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Aqua']}], 'interventions': [{'name': 'Glucose 20%', 'type': 'DRUG', 'description': 'The oral application of 0,3 ml/kg Glucose 20% 3 minutes before nasopharyngeal suctioning', 'armGroupLabels': ['Glucose 20%']}, {'name': 'Aqua', 'type': 'DRUG', 'description': 'The oral application of 0,3 ml/kg Aqua 3 minutes before nasopharyngeal suctioning', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50672', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christoph Huenseler, Dr med', 'role': 'CONTACT', 'email': 'christoph.huenseler@uni-koeln.de', 'phone': '0049-221-478-7190'}, {'name': 'Katharina Vezyroglou', 'role': 'CONTACT', 'email': 'katharina.vezyroglou@uk-koeln.de', 'phone': '0049-221-478-7190'}, {'name': 'Katharina Vezyroglou', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Angela Kribs, Dr med', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bernhard Roth, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lars Welzing, Dr med', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Frank Eifinger, Dr med', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne Vierzig, Dr med', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Neonatology, Children's Hospital, University of Cologne", 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Christoph Huenseler, Dr', 'role': 'CONTACT', 'email': 'christoph.huenseler@uni-koeln.de', 'phone': '0049-221-478-7190'}, {'name': 'Katharina Vezyroglou', 'role': 'CONTACT', 'email': 'katharina.vezyroglou@uk-koeln.de', 'phone': '0049-221-478-7190'}], 'overallOfficials': [{'name': 'Christoph Huenseler, Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Neonatology, Children's Hospital, University of Cologne"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. med Christoph Huenseler', 'oldOrganization': 'University of Cologne'}}}}