Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT03453502
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2018-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mother own milk feeding rates', 'timeFrame': 'three years'}], 'secondaryOutcomes': [{'measure': 'NICU costs', 'timeFrame': 'three years', 'description': 'costs during hospitalization in NICU'}, {'measure': 'the incidence of necrotizing enterocolitis (NEC)', 'timeFrame': 'three years', 'description': 'the incidence of necrotizing enterocolitis'}, {'measure': 'the incidence of sepsis', 'timeFrame': 'three years'}, {'measure': 'Reduce the incidence of enteral feed intolerance', 'timeFrame': 'three years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['quality improvement', 'breast milk'], 'conditions': ['Quality Improvement', 'Breast Milk']}, 'referencesModule': {'references': [{'pmid': '33190629', 'type': 'DERIVED', 'citation': 'Xu Y, Yu Z, Li Q, Zhou J, Yin X, Ma Y, Yin Y, Jiang S, Zhu R, Wu Y, Han L, Gao Y, Xue M, Qiao Y, Zhu L, Tu W, Wu M, Wan J, Wang W, Deng X, Li S, Wang S, Chen X, Zhou Q, Wang J, Cheng R, Wang J, Han S. Dose-dependent effect of human milk on Bronchopulmonary dysplasia in very low birth weight infants. BMC Pediatr. 2020 Nov 16;20(1):522. doi: 10.1186/s12887-020-02394-1.'}]}, 'descriptionModule': {'briefSummary': 'Twenty-seven hospitals in China will participate in the study, which aims to increase breastfeeding rate in the neonatal intensive care unit (NICU) and reduce the clinical complications in very low birth weight infants and extremely low birth weight infants.', 'detailedDescription': 'Breast milk reduces the risk of serious prematurity related morbidities. Quality improvement is an effective means of increasing breast milk feeding.Twenty-seven hospitals in China will participate in the study, which aims to increase breastfeeding rate in the NICU and reduce the clinical complications in very low birth weight infants and extremely low birth weight infants. This study compared the clinical data of very low birth weight infants and extremely low birth weight infants in three phases：Before-intervention phase，Intervention phase and Sustainability phase. During the Intervention phase and Sustainability phase multiple intervention bundles of quality improvement were implemented.The investigators will compare breast milk feeding rate and neonatal outcomes in different phases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '120 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* premature Infants (Birth weight\\<1500g)\n\nExclusion Criteria:\n\n* mother with sever illness or communicable disease'}, 'identificationModule': {'nctId': 'NCT03453502', 'briefTitle': 'Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units Using the Evidence-based Practice for Quality Improvement', 'orgStudyIdInfo': {'id': 'NMU-FY2017-350'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Before-intervention phase', 'description': 'All the very low birth weight (VLBW) and extremely low birth weight (ELBW) infants who were admitted from January 2017 to December 2017 to the NICUs of different hospitals.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention phase', 'description': 'All the VLBW and ELBW infants who were admitted from January 2018 to December 2018 to the NICUs.During this phase,multiple intervention bundles of quality improvement will be implemented.', 'interventionNames': ['Behavioral: Quality improvement of breast milk feeding']}, {'type': 'EXPERIMENTAL', 'label': 'Sustainability intervention phase', 'description': 'All the VLBW and ELBW infants who were admitted from January 2019 to December 2019to the NICUs.In the Sustainability intervention phase,multiple intervention bundles of quality improvement will be continuous implemented.', 'interventionNames': ['Behavioral: Quality improvement of breast milk feeding']}], 'interventions': [{'name': 'Quality improvement of breast milk feeding', 'type': 'BEHAVIORAL', 'description': 'During the Intervention phase and Sustainability phase ,The NICUs will receive training of multiple evidence based quality improvement methods.', 'armGroupLabels': ['Intervention phase', 'Sustainability intervention phase']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shuping Han, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nanjing Maternity and Child Health Care Hospital'}, {'name': 'Zhangbin Yu, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nanjing Maternity and Child Health Care Hospital'}, {'name': 'Jun Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing Maternity and Child Health Care Hospital'}, {'name': 'Yuhua Hu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jiangsu Women and Children Health Hospital'}, {'name': 'Shan Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The First People's Hospital of Lianyungang"}, {'name': 'Xiaoyi Deng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuzhou Maternity and Child Health Care Hospital'}, {'name': 'Zelin Jiao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Nanjing Medical University'}, {'name': 'Rui Cheng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Nanjing Medical University"}, {'name': 'Weiyuan Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Suqian Maternity and Child Health Care Hospital'}, {'name': 'Yan Gao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lianyungang Maternity and Child Health Care Hospital'}, {'name': 'Zhengying Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Wuxi Women's & Children's Hospital"}, {'name': 'Sannan Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Suzhou Municipal Hospital'}, {'name': 'Jinlan Chai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yancheng Maternity and Child Health Care Hospital'}, {'name': 'Zhun xu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The First People's Hospital of Yancheng"}, {'name': 'Jun Wan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Jiangyin Hospital of Southeast University Medical College'}, {'name': 'Weidong xu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The First People's Hospital of Zhangjiagang"}, {'name': 'Zhaofang Tian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University"}, {'name': 'Liangrong Han, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huaian Maternity and Child Health Care Hospital'}, {'name': 'Jinxiu Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changzhou Maternal and Child Care Hospital'}, {'name': 'Xuqin Mao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhenjiang Maternity and Child Health Care Hospital'}, {'name': 'Jun Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Hospital of Xuzhou Medical University'}, {'name': 'Mei Xue, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Taizhou People's Hospital"}, {'name': 'Hongyan Lu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Jiangsu University'}, {'name': 'Mingfu Wu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First People's Hospital of Hangzhou"}, {'name': 'Qin Zhou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wuxi Maternity and Child Health Care Hospital'}, {'name': 'Wenjuan Tu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Changzhou Children's Hospital"}, {'name': 'Lingling Zhu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Northern Jiangsu People's Hospital"}, {'name': 'Bin Sun, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Soochow University"}, {'name': 'Shuangshuang Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantong Maternity and Child Health Care Hospital'}, {'name': 'Xiaohui Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing Maternity and Child Health Care Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nanjing Maternity and Child Health Care Hospital', 'class': 'OTHER'}, {'name': 'Jiangsu Women and Children Health Hospital', 'class': 'UNKNOWN'}, {'name': "The First People's Hospital of Lianyungang", 'class': 'OTHER'}, {'name': 'Xuzhou Maternity and Child Health Care Hospital', 'class': 'OTHER'}, {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, {'name': "Children's Hospital of Nanjing Medical University", 'class': 'OTHER'}, {'name': 'Suqian Maternity and Child Health Care Hospital', 'class': 'UNKNOWN'}, {'name': 'Lianyungang Maternity and Child Health Care Hospital', 'class': 'UNKNOWN'}, {'name': "Wuxi Women's & Children's Hospital", 'class': 'OTHER'}, {'name': 'Suzhou Municipal Hospital', 'class': 'OTHER'}, {'name': 'Yancheng Maternity and Child Health Care Hospital', 'class': 'UNKNOWN'}, {'name': "The First People's Hospital of Yancheng", 'class': 'UNKNOWN'}, {'name': 'The Affiliated Jiangyin Hospital of Southeast University Medical College', 'class': 'UNKNOWN'}, {'name': "The First People's Hospital of Zhangjiagang", 'class': 'UNKNOWN'}, {'name': "The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University", 'class': 'UNKNOWN'}, {'name': 'Huaian Maternity and Child Health Care Hospital', 'class': 'UNKNOWN'}, {'name': 'Changzhou Maternal and Child Care Hospital', 'class': 'OTHER'}, {'name': 'Zhenjiang Maternity and Child Health Care Hospital', 'class': 'UNKNOWN'}, {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}, {'name': "Taizhou People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Affiliated Hospital of Jiangsu University', 'class': 'OTHER'}, {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, {'name': 'Wuxi Maternity and Child Health Care Hospital', 'class': 'UNKNOWN'}, {'name': "Changzhou Children's Hospital", 'class': 'UNKNOWN'}, {'name': "Northern Jiangsu People's Hospital", 'class': 'OTHER'}, {'name': "Children's Hospital of Soochow University", 'class': 'OTHER'}, {'name': 'Nantong Maternity and Child Health Care Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhangbin Yu', 'investigatorAffiliation': 'Nanjing Medical University'}}}}