Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-03 @ 2:07 PM
Study NCT ID:
NCT02048202
Status:
UNKNOWN
Last Update Posted:
2015-05-05
First Post:
2014-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical Clowning in the NICU (Neonatal Intensive Care Unit and Their Effects on Parents and Staff
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-03', 'studyFirstSubmitDate': '2014-01-21', 'studyFirstSubmitQcDate': '2014-01-27', 'lastUpdatePostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '◦Developmental assessment - a composite of several measures', 'timeFrame': '◦Time Frame: 3 month'}], 'secondaryOutcomes': [{'measure': 'Developmental assessment - a composite of several measures', 'timeFrame': '◦◦Time Frame: 18 month', 'description': 'Safety Issue?: No'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clown', 'neonate', 'premature'], 'conditions': ['Premature Neonate']}, 'descriptionModule': {'briefSummary': 'The study will compare intervention by Infant Aquatics to infant massage. The intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive behavior scales.', 'detailedDescription': 'Preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly due to developmental brain injury. Infant Aquatics have been found to benefit and promote infant development. The support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premature neonates 32 weeks gestation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* neonates wherein their parents have expressed consent to participate in trail\n* neonates with parents who are able to understand and fill in questioners\n* neonates with no chromosomal deficiencies and no genetic deficiency\n\nExclusion Criteria:\n\n* neonates with parents who are unable to understand and fill in questioners\n* neonates with intraventricular bleeding IVH/PVH\n* neonates with periventricular hemorrhage\n* neonates with known chromosomal deficiencies or genetic deficiency'}, 'identificationModule': {'nctId': 'NCT02048202', 'acronym': 'clowns', 'briefTitle': 'Medical Clowning in the NICU (Neonatal Intensive Care Unit and Their Effects on Parents and Staff', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The Baruch Padeh Medical Center, Poriya'}, 'officialTitle': 'Effects of Medical Clowning (Dream Doctors) on the Development of the Nervous System and the Relationship Between Preterm Premature Baby Parents and NICU Staff', 'orgStudyIdInfo': {'id': '38-2013.CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'premature neonate', 'description': 'premature neonate'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15208', 'city': 'Tiberias', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Shay Barak, MD', 'role': 'CONTACT', 'email': 'sbarak@poria.health.gov.il', 'phone': '050-6267496'}, {'name': 'Hagit Friedman, PhD', 'role': 'CONTACT', 'email': 'hmts@netvision.net.il', 'phone': '050-5841317'}, {'name': 'Shay Barak, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amir Kushnir, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shosh Ofir', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Orly Benor, RN', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aminat Libay, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hagit Friedman, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Baruch Padeh Medical Center - Poria', 'geoPoint': {'lat': 32.79221, 'lon': 35.53124}}], 'centralContacts': [{'name': 'Shay Barak, MD', 'role': 'CONTACT', 'email': 'sbarak@poria.health.gov.il', 'phone': '050-6267496'}, {'name': 'Hagit Friedman, PhD', 'role': 'CONTACT', 'email': 'hmts@netvision.net.il', 'phone': '050-6267427'}], 'overallOfficials': [{'name': 'Shay Barak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Baruch Padeh Medical Center - Poria'}, {'name': 'Amir Kushnir, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Baruch Padeh Medical Center - Poria'}, {'name': 'Hagit Friedman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Haifa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Baruch Padeh Medical Center, Poriya', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Haifa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}