Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-01 @ 12:51 PM
Study NCT ID:
NCT01544257
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
2012-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms
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'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-28', 'studyFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2012-02-28', 'lastUpdatePostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluate the effectiveness of OMT in reducing LOS', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}], 'secondaryOutcomes': [{'measure': 'pre-post difference in weight gain', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteopathic manipulative treatment', 'alternative medicine', 'complementary medicine', 'neonatology', 'neonatal care', 'prematurity', 'allied health care'], 'conditions': ['Prematurity']}, 'referencesModule': {'references': [{'pmid': '23622070', 'type': 'DERIVED', 'citation': "Cerritelli F, Pizzolorusso G, Ciardelli F, La Mola E, Cozzolino V, Renzetti C, D'Incecco C, Fusilli P, Sabatino G, Barlafante G. Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial. BMC Pediatr. 2013 Apr 26;13:65. doi: 10.1186/1471-2431-13-65."}]}, 'descriptionModule': {'briefSummary': 'The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of the present study is to show the effect of OMT on LOS in a sample of premature infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'minimumAge': '29 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infants born at age between 29 and 37 weeks\n* osteopathic treatment performed \\< 14 days after birth\n* preterms born in the same hospital\n\nExclusion Criteria:\n\n* gestational age \\< 29, \\> 37 weeks;\n* osteopathic treatment performed \\> 14 days after birth;\n* newborn transferred to/from other hospital;\n* newborn from to HIV seropositive and/or drug addict mother;\n* newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.'}, 'identificationModule': {'nctId': 'NCT01544257', 'briefTitle': 'Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms', 'organization': {'class': 'OTHER', 'fullName': 'European Institute for Evidence Based Osteopathic Medicine'}, 'officialTitle': 'Effect of OMT on Length of Stay in a Population of Preterm Infants: RCT Study', 'orgStudyIdInfo': {'id': 'NEO-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OMT', 'description': 'patients under standard medical care plus OMT.', 'interventionNames': ['Other: osteopathic manipulative treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'patients under standard medical care plus only osteopathic evaluation', 'interventionNames': ['Procedure: Usual care']}], 'interventions': [{'name': 'osteopathic manipulative treatment', 'type': 'OTHER', 'description': 'Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.', 'armGroupLabels': ['OMT']}, {'name': 'Usual care', 'type': 'PROCEDURE', 'description': 'Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65124', 'city': 'Pescara', 'country': 'Italy', 'facility': 'Francesco Cerritelli', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}], 'overallOfficials': [{'name': 'Francesco Cerritelli, DO, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'European Institute for Evidence Based Osteopathic Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute for Evidence Based Osteopathic Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}