Clinical trial NCT04383379: To Improve the Rate of Mother's Own Milk Feeding of Premature Infants in NICU
Official title: Evidence-Based Practice for Improving Quality(EPIQ) to Improve the Rate of Mother's Own Milk Feeding of Premature Infants in NICU: Study Protocol for a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quality Improvement
Breast-feeding
Premature Infant
Keywords: Quality Improvement
breast-feeding
premature infant
cluster randomized controlled
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Maternity and Child Health Care Hospital
name: Jiangsu Maternity and Child Health Care Hospital
name: Xuzhou Maternity and Child Health Care Hospital
name: Affiliated Hospital of Jiangsu University
name: Yangzhou Maternity and Child Health Care Hospital
name: Lianyungang Maternity and Child Health Care Hospital
name: Nantong Maternity and Child Health Care Hospital
name: The First People's Hospital of Jiangyin
name: Yangzhou No.1 People's Hospital
name: Subei people's Hospital
name: Wuxi Maternity and Child Health Care Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: Changzhou Maternal and Child Care Hospital
First posted: 2020-05-12
Enrollment: 1500
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Thirteen hospitals in China will participate in the study, which objectives of this study is to improve the rate of mother's own milk feeding of premature infants in neonatal intensive care unit(NICU), evaluate the effectiveness of improving the quality of breastfeeding in clinical use ,form standardized process and improve clinical medical quality of premature infants.

Detailed description: In this study, the cluster randomized controlled matching design was used. Considering that evidence-based practice for improving quality(EPIQ) method is not only to improve the quality of individual, but also to improve the quality of breast-feeding of the whole neonatal intensive care unit(NICU), so a hospital was chosen as a cluster. The supervision unit is used for the quality control , coordination and technical support in the whole study process.The two NICU with similar number of premature infants, the same scale of NICU and little difference in the recognition of breast-feeding quality improvement measures that meet the inclusion criteria are taken as the a floor, and then randomly divided into two groups, taking the NICU as intervention group or the control group can avoid the individual influence of the intervention. In this study, recruited 12 NICUs. The purpose of study is to to increase the consumption of mother's own milk of premature infants through the existing measures of improving the breastfeeding quality, and then to improve the quality of life of the premature infant, and to further evaluate whether this model of improving the breastfeeding quality can be promoted in other NICU.

Eligibility criteria: Inclusion Criteria:

* Weight less than 1500g or gestational age less than 32 weeks;
* Admission to NICU.

Exclusion Criteria:

* Pregnancy with serious diseases, infectious diseases or other medical contraindications for breast-feeding (such as galactosemia);
* infants did not survive were excluded.

Primary outcomes:
measure: exclusive breastfeeding rate 24 hours before discharge
timeFrame: two years
Secondary outcomes:
measure: Time of Mother's Own Milk at starting feed（hours）
timeFrame: two years
measure: Proportion of first time Mother's Own Milk (%)
timeFrame: two years
measure: Duration of parenteral nutrition (days)
timeFrame: two years
measure: Time to total gastrointestinal feeding (days)
timeFrame: two years
measure: Pump milk times (times /d) and amount (ml / d) ：1-3d, 4-7d ,8-14d
timeFrame: two years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Maternity and Child Health Care Hospital
name: Han Shuping, PhD
role: STUDY_DIRECTOR
affiliation: Nanjing Maternity and Child Health Care Hospital
name: Yu Zhangbin, PhD
role: STUDY_DIRECTOR
affiliation: Jiangsu Maternity and Child Health Care Hospital
name: Chen Xiaoqing, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuzhou Maternity and Child Health Care Hospital
name: Deng Xiaoyi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Jiangsu University
name: Lu Hongyan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yangzhou Maternity and Child Health Care Hospital
name: Wu Xinping, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lianyungang Maternity and Child Health Care Hospital
name: Gao Yan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantong Maternity and Child Health Care Hospital
name: Li Shuangshuang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First People's Hospital of Jiangyin
name: Wan Jun, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yangzhou No.1 People's Hospital
name: Wu Mingfu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Subei people's Hospital
name: Zhu Lingling, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuxi Maternity and Child Health Care Hospital
name: Zhou Qin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Wang Jun, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Changzhou Maternal and Child Care Hospital
name: Wang Huaiyan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huo J, Wu X, Gu C, Yu Z, Zhang J, Chen X, Zhu J, Liu F, Liu B, Li Q, Han S. Using a WeChat mini-program-based lactation consultant intervention to increase the consumption of mother's own milk by preterm infants in the neonatal intensive care unit: a study protocol for a cluster randomized controlled trial. Trials. 2021 Nov 24;22(1):834. doi: 10.1186/s13063-021-05731-6.