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NCT Number: NCT03453502

Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units

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.

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Key information

Conditions

Quality Improvement Breast Milk

Age range

Up to 120 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • premature Infants (Birth weight<1500g)

Exclusion criteria

  • mother with sever illness or communicable disease

Treatment and study plan

Quality improvement of breast milk feeding

Behavioral

During the Intervention phase and Sustainability phase ,The NICUs will receive training of multiple evidence based quality improvement methods.

Primary outcomes

  1. mother own milk feeding rates

    Time frame: three years

Secondary outcomes

  1. NICU costs

    Time frame: three years

    costs during hospitalization in NICU

  2. the incidence of necrotizing enterocolitis (NEC)

    Time frame: three years

    the incidence of necrotizing enterocolitis

  3. the incidence of sepsis

    Time frame: three years

  4. Reduce the incidence of enteral feed intolerance

    Time frame: three years

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • 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 Taizhou People's 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 People's Hospital
  • Suqian Maternity and Child Health Care Hospital
  • Suzhou Municipal 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 Maternity and Child Health Care Hospital
  • Wuxi Women's & Children's Hospital
  • Xuzhou Maternity and Child Health Care Hospital
  • Yancheng Maternity and Child Health Care Hospital
  • Zhenjiang Maternity and Child Health Care Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2018
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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