Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT03833635
Status:
UNKNOWN
Last Update Posted:
2019-03-25
First Post:
2019-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of OMT on Premature Physiological Parameters
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-21', 'studyFirstSubmitDate': '2019-02-06', 'studyFirstSubmitQcDate': '2019-02-06', 'lastUpdatePostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'heart rate', 'timeFrame': 'immediate', 'description': 'measure of heart rate'}], 'secondaryOutcomes': [{'measure': 'oxygen saturation', 'timeFrame': 'immediate', 'description': 'measure of oxygen'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Infant', 'Physiological Stress']}, 'referencesModule': {'references': [{'pmid': '32379655', 'type': 'DERIVED', 'citation': 'Manzotti A, Cerritelli F, Lombardi E, La Rocca S, Chiera M, Galli M, Lista G. Effects of osteopathic treatment versus static touch on heart rate and oxygen saturation in premature babies: A randomized controlled trial. Complement Ther Clin Pract. 2020 May;39:101116. doi: 10.1016/j.ctcp.2020.101116. Epub 2020 Feb 8.'}]}, 'descriptionModule': {'briefSummary': 'Osteopathic manipulative treatment has been showed to reduce LOS in premature infants. Despite the clinical effectiveness, lack of data and information on the physiological underpinning effects during the treatment has been revealed. The aim of the study is to explore the immediate physiological effects of osteopathic treatment on premature infants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infants\n\nExclusion Criteria:\n\n* congenital/genetic disease\n* cardiovascular/neurological disease'}, 'identificationModule': {'nctId': 'NCT03833635', 'briefTitle': 'Effects of OMT on Premature Physiological Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Come Collaboration'}, 'officialTitle': 'Effects of OMT on Premature Physiological Parameters: a RCT', 'orgStudyIdInfo': {'id': 'COME-01-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OMT', 'interventionNames': ['Other: osteopathic manipulative treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Sham']}], 'interventions': [{'name': 'osteopathic manipulative treatment', 'type': 'OTHER', 'description': 'OMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect', 'armGroupLabels': ['OMT']}, {'name': 'Sham', 'type': 'OTHER', 'description': 'the sham intervention consists in a stable skin-to-skin contact with the participant', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66100', 'city': 'Chieti', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Cerritelli, DO, MS', 'role': 'CONTACT', 'email': 'francesco.cerritelli@gmail.com', 'phone': '+393394332801'}], 'facility': 'University of Chieti-Pescara', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'zip': '20154', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Manzotti, PT, DO', 'role': 'CONTACT', 'email': 'andreamanzotti@soma-osteopatia.it', 'phone': '+3902 2052 0939'}], 'facility': 'Buzzi hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Come Collaboration', 'class': 'OTHER'}, 'collaborators': [{'name': "Vittore Buzzi Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}