Ignite Creation Date:
2025-12-24 @ 12:48 PM
Ignite Modification Date:
2026-04-16 @ 6:58 PM
Study NCT ID:
NCT01779661
Status:
UNKNOWN
Last Update Posted:
2014-02-13
First Post:
2013-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infant Aquatics Neurodevelopment Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'lastUpdateSubmitDate': '2014-02-12', 'studyFirstSubmitDate': '2013-01-27', 'studyFirstSubmitQcDate': '2013-01-27', 'lastUpdatePostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Developmental assessment - a composite of several measures', 'timeFrame': '3 month', 'description': 'Developmental assessment at term and three month\n\n1. General Movements Neuromotor scale\n2. Neurological examination'}], 'secondaryOutcomes': [{'measure': 'Developmental assessment - a composite of several measures', 'timeFrame': '18 month', 'description': 'Developmental assessment at 18 month\n\n1. IMP neuromotor developmental scale\n2. Griffith mental development scale\n3. Vineland adaptive behavior scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neurodevelopment, Infant-Aquatics, Prematurity'], 'conditions': ['Cerebral Palsy', 'Preterm Birth', 'Development']}, 'descriptionModule': {'briefSummary': 'The objective of this research is to examine the effect of Infant Aquatics on the development of and neurodevelopment of preterm and near-term infants, using the GM as prognostic estimation of future development.\n\nPreterm 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Weeks', 'minimumAge': '1 Week', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMajor inclusion criteria: Infants who are hemodynamic stable, no seizures or apnea attacks, IVH/PVH grade \\< 3, without diagnoses of chromosomal abnormalities, infants whose parents want to cooperate, will be included. These criteria follow our aim to include vulnerable groups of infants for which research results may dramatically promote development.\n\nExclusion Criteria:\n\ninfants whose parents are not able to understand research goals and refuse to cooperate, infants with seizures or apnea attacks, IVH/PVH grade \\>or =3, with diagnoses of chromosomal abnormalities.'}, 'identificationModule': {'nctId': 'NCT01779661', 'acronym': 'IA-NPI', 'briefTitle': 'Infant Aquatics Neurodevelopment Premature Infants', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Effect of Infant Aquatics for Neurodevelopment of Premature Infants', 'orgStudyIdInfo': {'id': 'SHEBA-12-9524-OB-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Infant Aquatics', 'interventionNames': ['Other: Infant Aquatics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infant Massage', 'description': 'Infant Massage', 'interventionNames': ['Other: Infant Massage']}], 'interventions': [{'name': 'Infant Aquatics', 'type': 'OTHER', 'description': "Infant Aquatics in this study is composed of a set of pre-structured movements and techniques of relaxation, through harmonic integration of various approaches, each having a role in a specific time-window or in the infant's developmental sequence along study interventional timeline", 'armGroupLabels': ['Infant Aquatics']}, {'name': 'Infant Massage', 'type': 'OTHER', 'description': 'Infant Massage', 'armGroupLabels': ['Infant Massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56210', 'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Omer Bar-Yosef, MD PhD', 'role': 'CONTACT', 'email': 'omerbary@gmail.com'}, {'name': 'Caroline Barmatz, HT BPT MHA', 'role': 'CONTACT', 'email': 'caroline.barmatz@gmail.com]'}, {'name': 'Hagit Friedman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Omer Bar-Yosef, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Caroline Barmatz, HT.BPT.MHA', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Iris Morag, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anat Lazits-Dor, BPT', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Keren Mekadesh, RN BA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Zipora Strauss, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chaim Seba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Hagit Friedman, PhD', 'role': 'CONTACT', 'email': 'hmts@netvision.net.il', 'phone': '972-54-5841314'}, {'name': 'Omer Bar-Yosef, MD PhD', 'role': 'CONTACT', 'email': 'omerbary@gmail.com', 'phone': '972-52-6667344'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Haifa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}