Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units

Quality Improvement Clinical Trial

Official title:

Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units Using the Evidence-based Practice for Quality Improvement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453502
• Other study ID #: NMU-FY2017-350
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2021
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Days

Eligibility

Inclusion Criteria:

• premature Infants (Birth weight<1500g)

Exclusion Criteria:

• mother with sever illness or communicable disease

Related Conditions & MeSH terms

• Breast Milk
• Quality Improvement

Intervention

Behavioral:
• Quality improvement of breast milk feeding
During the Intervention phase and Sustainability phase ,The NICUs will receive training of multiple evidence based quality improvement methods.

Locations

Country	Name	City	State
n/a

Sponsors (28)

Lead Sponsor

Collaborator

Nanjing Medical University

Affiliated Hospital of Jiangsu University, Changzhou Children's Hospital, Changzhou Maternal and Child Care Hospital, Children's Hospital of Nanjing Medical University, Children's Hospital Of Soochow University, First People's Hospital of Hangzhou, Huaian Maternity and Child Health Care Hospital, Jiangsu Women and Children Health Hospital, Lianyungang Maternity and Child Health Care Hospital, Nanjing Maternity and Child Health Care Hospital, Nantong Maternity and Child Health Care Hospital, Northern Jiangsu Province People's Hospital, Suqian Maternity and Child Health Care Hospital, Suzhou Municipal Hospital, Taizhou People's Hospital, The Affiliated Hospital of Xuzhou Medical University, The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University, The Affiliated Jiangyin Hospital of Southeast University Medical College, The First People's Hospital of Lianyungang, The First People's Hospital of Yancheng, The First People's Hospital of Zhangjiagang, The Second Hospital of Nanjing Medical University, Wuxi Children's Hospital, Wuxi Maternity and Child Health Care Hospital, Xuzhou Maternity and Child Health Care Hospital, Yancheng Maternity and Child Health Care Hospital, Zhenjiang Maternity and Child Health Care Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mother own milk feeding rates		three years
Secondary	NICU costs	costs during hospitalization in NICU	three years
Secondary	the incidence of necrotizing enterocolitis (NEC)	the incidence of necrotizing enterocolitis	three years
Secondary	the incidence of sepsis		three years
Secondary	Reduce the incidence of enteral feed intolerance		three years