Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-03-03 @ 3:55 PM
Study NCT ID:
NCT01742520
Status:
UNKNOWN
Last Update Posted:
2013-06-11
First Post:
2012-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurodevelopmental Outcomes of Preterm Infants Treated for Pain Management With Repeated Doses of Sucrose 24%
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005526', 'term': 'Food, Formulated'}, {'id': 'D008895', 'term': 'Milk, Human'}], 'ancestors': [{'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D003611', 'term': 'Dairy Products'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-09', 'studyFirstSubmitDate': '2012-11-18', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neurodevelopmental outcomes', 'timeFrame': 'at 6 month corrected age', 'description': 'Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel'}], 'secondaryOutcomes': [{'measure': 'neurodevelopment', 'timeFrame': 'at 15 weeks corrected age', 'description': 'Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preterm infant', 'pain', 'neurodevelopment'], 'conditions': ['Development']}, 'referencesModule': {'references': [{'pmid': '12205254', 'type': 'RESULT', 'citation': "Johnston CC, Filion F, Snider L, Majnemer A, Limperopoulos C, Walker CD, Veilleux A, Pelausa E, Cake H, Stone S, Sherrard A, Boyer K. Routine sucrose analgesia during the first week of life in neonates younger than 31 weeks' postconceptional age. Pediatrics. 2002 Sep;110(3):523-8. doi: 10.1542/peds.110.3.523."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of sucrose 24% for pain prevention on preterm infants. Our hypothesis is that repeated doses of sucrose 24%, given prior to painful procedure,do not impair neurodevelopmental outcomes of preterm infants', 'detailedDescription': 'preterm infants born at 27-33 weeks gestational age at Sheba Medical Center will be recruited for this study. Prior to invasive procedure infants will be treated with pacifier and swaddling as recommended by the American Academy of Pediatrics and Canadian Pediatric Society.\n\nGroup 1.Will be treated with Sucrose 24% 0.1-0.5ml on the anterior pat of the tongue 1-3 min prior to invasive procedure.\n\nGroup 2. Similar to group 1 but breast milk or formula will replace Sucrose.\n\nNumber of invasive procedures/day will be documented\n\nGeneral Movements by Prechtel will be used for developmental assessment at 2,4,6 weeks after birth and at 14-16 weeks corrected age\n\nGriffiths developmental scales (GMDS) will be used at 40 weeks, 14-16 weeks corrected age, and 3-6 month corrected age'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '33 Weeks', 'minimumAge': '27 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infants born at SMC\n\nExclusion Criteria:\n\n* need for intubation\n* surgery\n* need for sedation\n* abnormal head ultrasound\n* genetic abnormalities\n* necrotizing enterocolitis\n* other painful conditions other than routine blood exams'}, 'identificationModule': {'nctId': 'NCT01742520', 'briefTitle': 'Neurodevelopmental Outcomes of Preterm Infants Treated for Pain Management With Repeated Doses of Sucrose 24%', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Its an Interventional Study That Will Evaluate the Effect of Different Doses of Sucrose 24% on Neurodevelopmental Outcome of Preterm Infants', 'orgStudyIdInfo': {'id': 'SHEBA-12-9389-IM-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Formula or Breast Milk', 'description': 'Breast milk or formula prior to every painful procedure.', 'interventionNames': ['Drug: Formula or breast milk']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multiple doses of sucrose', 'description': 'Infants in this group will be treated with Sucrose 24% 0.5-1ml on the anterior pat of the tongue 1-3min prior to every invasive procedure', 'interventionNames': ['Drug: multiple doses of sucrose']}], 'interventions': [{'name': 'multiple doses of sucrose', 'type': 'DRUG', 'otherNames': ['sucrose 24%'], 'description': 'unlimited number of doses par day- current status in our NICU', 'armGroupLabels': ['Multiple doses of sucrose']}, {'name': 'Formula or breast milk', 'type': 'DRUG', 'otherNames': ['sucrose 24%'], 'description': '1-3 minutes prior to every painful procedure, breast milk or formula 0.5-1 ml will be given on the anterior part of the tongue', 'armGroupLabels': ['Formula or Breast Milk']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Iris Morag, MD', 'role': 'CONTACT', 'email': 'irismorag@gmail.com', 'phone': '+9725307170'}, {'name': 'Tzipora Strauss, MD', 'role': 'CONTACT', 'phone': '+9725302227'}, {'name': 'Iris Morag, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Iris Morag, MD', 'role': 'CONTACT', 'email': 'irismorag@gmail.com', 'phone': '+972526479996'}, {'name': 'Tzipi Strauss, MD', 'role': 'CONTACT', 'email': 't.tzipi@gmail.com', 'phone': '+97235302215'}], 'overallOfficials': [{'name': 'Iris Morag, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Neonatologist', 'investigatorFullName': 'Dr. Iris Morag', 'investigatorAffiliation': 'Sheba Medical Center'}}}}