Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-04-22 @ 10:01 PM
Study NCT ID:
NCT03061968
Status:
UNKNOWN
Last Update Posted:
2017-02-24
First Post:
2011-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Applying Acupressure in Low-birth Weight Premature
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001835', 'term': 'Body Weight'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019050', 'term': 'Acupressure'}], 'ancestors': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2011-01-12', 'studyFirstSubmitQcDate': '2017-02-19', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': '15 days.', 'description': 'The data will be collected by a self-developed structured questionnaire, including: 1) demographic data of premature; 2)body weight every day until discharge.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acupressure', 'very-low- birth-weight premature', 'body weight', 'behavioral state', 'developmental status'], 'conditions': ['Premature']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of acupressure application in very low birth weight premature.', 'detailedDescription': 'A quasi-experimental study is designed. Sixty premature babies will be recruited by purposed sampling, according to the criteria of very low birth weight (\\<1500gm) from a sick baby room in a medical center. The control group only receive routine care in sick baby room unite. The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for 15 days, and continuously recoding the observation and records until discharge. The intervention includes acupressure for 15 minutes each at 10Am, 1Pm and 4Pm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* according to the criteria of very low birth weight (\\<1500gm) from a sick baby room in a medical center.\n\nExclusion Criteria:\n\n* Exclusion criteria of very low birth weight (\\>1500gm) from a sick baby room in a medical center.'}, 'identificationModule': {'nctId': 'NCT03061968', 'briefTitle': 'Study of Applying Acupressure in Low-birth Weight Premature', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Study of Appling Acupressure in Low-birth Weight Premature', 'orgStudyIdInfo': {'id': 'DMR98-IRB-245-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge.', 'interventionNames': ['Behavioral: acupressure']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'The control group only receive routine care in sick baby room unite.'}], 'interventions': [{'name': 'acupressure', 'type': 'BEHAVIORAL', 'description': 'The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge.', 'armGroupLabels': ['experimental group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Li-Li Chen', 'class': 'OTHER'}, 'collaborators': [{'name': 'China Medical University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Li-Li Chen', 'investigatorAffiliation': 'China Medical University Hospital'}}}}