Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-14 @ 4:06 AM
Study NCT ID:
NCT01784835
Status:
COMPLETED
Last Update Posted:
2013-02-06
First Post:
2013-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Exposure to OMT Prevents Long LOS
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-04', 'studyFirstSubmitDate': '2013-02-04', 'studyFirstSubmitQcDate': '2013-02-04', 'lastUpdatePostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days of LOS', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}], 'secondaryOutcomes': [{'measure': 'effectiveness of OMT considering different lag time between birth and the first OMT', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 4 weeks'}]}, 'conditionsModule': {'keywords': ['Osteopathic manipulative treatment', 'neonatology', 'neonatal care', 'prematurity', 'complementary and alternative medicine', 'length of stay'], 'conditions': ['Prematurity']}, 'referencesModule': {'references': [{'pmid': '21711535', 'type': 'BACKGROUND', 'citation': "Pizzolorusso G, Turi P, Barlafante G, Cerritelli F, Renzetti C, Cozzolino V, D'Orazio M, Fusilli P, Carinci F, D'Incecco C. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study. Chiropr Man Therap. 2011 Jun 28;19(1):15. doi: 10.1186/2045-709X-19-15."}]}, 'descriptionModule': {'briefSummary': 'The application of osteopathic manipulative treatment (OMT) in preterm infants has been demonstrated to be effective in reducing length of stay (LOS). The scope of the present study is to investigate the association between earlier exposure to OMT and reduction of LOS in premature infants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'minimumAge': '32 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 weeks\n* Gestational age \\> 37 weeks\n* First OMT performed after 14 days from birth\n* genetic disorders\n* congenital disorders\n* cardiovascular abnormalities\n* proven or suspected necrotized enterocolitis with or without gastrointestinal perforation proven or suspected abdominal obstruction\n* pre/post surgery patients\n* pneumoperitoneum\n* atelectasis\n* Newborn from an HIV seropositive/drug addicted mother\n* respiratory disorders\n* transferred to/from other hospital\n* admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)'}, 'identificationModule': {'nctId': 'NCT01784835', 'briefTitle': 'Early Exposure to OMT Prevents Long LOS', 'organization': {'class': 'OTHER', 'fullName': 'European Institute for Evidence Based Osteopathic Medicine'}, 'orgStudyIdInfo': {'id': 'NEO-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'control', 'description': 'patients under standard medical care', 'interventionNames': ['Other: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'OMT', 'description': 'patients under usual medical care plus osteopathic treatment', 'interventionNames': ['Other: osteopathic manipulative treatment']}], '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': 'OTHER', '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': '62100', 'city': 'Macerata', 'state': 'Macerata', 'country': 'Italy', 'facility': 'Macerata Hospital', 'geoPoint': {'lat': 43.29789, 'lon': 13.45293}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute for Evidence Based Osteopathic Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}