Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT02980250
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2016-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-Center Study of Different Doses Domperidone in Feeding Intolerance
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': 'D003276', 'term': 'Contraceptives, Oral'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-13', 'studyFirstSubmitDate': '2016-11-30', 'studyFirstSubmitQcDate': '2016-12-01', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '1 month'}], 'primaryOutcomes': [{'measure': 'the residual glucose percentage', 'timeFrame': '7 days', 'description': '3kg/kg 5% glucose will be injected into the gastric tube .The residual glucose will be drawed out from the gastric tube after 30 min'}], 'secondaryOutcomes': [{'measure': 'the percentage of residual milk', 'timeFrame': '7 days', 'description': 'the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['feeding intolerance', 'premature infant', 'domperidone'], 'conditions': ['Feeding Intolerance', 'Premature Birth', 'Domperidone Overdose', 'Gastric Retention']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical multi-center study is to determine whether different doses of domperidone are effective in the treatment of feeding intolerance in premature infant', 'detailedDescription': 'the premature infant have been divided into four group.The first group take the 0.2mg/kg/tds domperidone as treatment ,while the other group take the 0.4mg/kg/tds domperidone,0.6mg/kg/tds domperidone and the placebo respectively .\n\nAn objective index has been decided to evaluate the severity of feeding intolerance in the premature infant. 3kg/kg 5% glucose will be injected into the gastric tube .The residual glucose will be drawed out from the gastric tube. The residual percentage is the main result of the study.\n\nThe main result will be compared by the secondary result to help to explain the accuracy. The secondary result is the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.\n\nAny adverse effect will be recorded and analysed to figure out whether is associate with the domperidone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Weeks', 'minimumAge': '20 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the residual milk and glucose over 55%\n* abdominal distention or vomiting;\n* Reduce,delay or disruption of enteral feeding\n\nExclusion Criteria:\n\n* Four weeks before the start of this study had participated in other clinical trials\n* pulmonary hypertension;\n* Infants with necrotizing enterocolitis\n* Gastrointestinal tract malformation, congenital heart disease\n* Pre-existing QT extend/between long QT syndrome;\n* ascites\n* Have been used or will use drugs suppress CYP3A4\n* Other risk factors for prolong the QT'}, 'identificationModule': {'nctId': 'NCT02980250', 'acronym': 'MCSDDDFI', 'briefTitle': 'Multi-Center Study of Different Doses Domperidone in Feeding Intolerance', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'A Clinical Multi-Center Study of Efficacy Analysis in Different Doses of Domperidone in Feeding Intolerance of Premature Infant', 'orgStudyIdInfo': {'id': 'NFEC-2015-131'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low dose', 'description': 'The premature infant in this group will be feed with 0.2mg/kg/tds domperidone suspension(motilium;100ml)for 7 days and will be tested the residual percentage everyday.', 'interventionNames': ['Drug: Low dose']}, {'type': 'EXPERIMENTAL', 'label': 'normal dose', 'description': 'The premature infant in this group will be feed with 0.4mg/kg/tds domperidone suspension(motilium;100ml)for 7 days and will be tested the residual percentage everyday.', 'interventionNames': ['Drug: normal dose']}, {'type': 'EXPERIMENTAL', 'label': 'over dose', 'description': 'The premature infant in this group will be feed with 0.6mg/kg/tds domperidone suspension(motilium;100ml)for 7 days and will be tested the residual percentage everyday.', 'interventionNames': ['Drug: over dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'The premature infant in this group will be feed with some vitamin which will dilute into the 5% glucose and have the same appearance and taste with the experimental team for 7 days and will be tested the residual percentage everyday.', 'interventionNames': ['Drug: Glucose']}], 'interventions': [{'name': 'Low dose', 'type': 'DRUG', 'otherNames': ['Domperidone Suspension(Motilium), B12200018238'], 'description': '0.2mg group-The premature infant will be fed with 0.2mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.', 'armGroupLabels': ['low dose']}, {'name': 'normal dose', 'type': 'DRUG', 'otherNames': ['Domperidone Suspension(Motilium), B12200018238'], 'description': '0.4mg group-The premature infant will be fed with 0.4mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.', 'armGroupLabels': ['normal dose']}, {'name': 'over dose', 'type': 'DRUG', 'otherNames': ['Domperidone Suspension(Motilium), B12200018238'], 'description': '0.6mg group-The premature infant will be fed with 0.6mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.', 'armGroupLabels': ['over dose']}, {'name': 'Glucose', 'type': 'DRUG', 'otherNames': ['5% Glucose'], 'description': 'Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'WeiMing Huang, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Nanfang Hosiptal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangdong Provincial Maternal and Child Health Hospital', 'class': 'OTHER'}, {'name': 'Shen-Zhen City Maternity and Child Healthcare Hospital', 'class': 'OTHER'}, {'name': 'Maternal and Child Health Hospital of Foshan', 'class': 'OTHER'}, {'name': 'Guangzhou Panyu Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The director of the neonatology department', 'investigatorFullName': 'Weimin Huang', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}