Quality ImprovementNCT03453502
Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units
A study testing Quality improvement of breast milk feeding in people with Quality Improvement and Breast Milk, run by Nanjing Medical University.
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. Read more about this study
- Who is it for?
- Ages Up to 120 days
- Conditions the study is for
- Quality Improvement, Breast Milk
- What is being tested?
- Quality improvement of breast milk feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- premature Infants (Birth weight<1500g)
Who cannot join
- mother with sever illness or communicable disease
About this study
Official title: Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units Using the Evidence-based Practice for Quality Improvement
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.
Read the detailed 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.
- Conditions
- Quality Improvement, Breast Milk
- Being tested
- Quality improvement of breast milk feeding
- Keywords
- quality improvement, breast milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality improvement of breast milk feedingBehavioural
During the Intervention phase and Sustainability phase ,The NICUs will receive training of multiple evidence based quality improvement methods.
| Study group | Role | What they receive |
|---|---|---|
| Before-intervention phase | No intervention | 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. |
| Intervention phase | Experimental | 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. Receives: Behavioral: Quality improvement of breast milk feeding |
| Sustainability intervention phase | Experimental | 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. Receives: Behavioral: Quality improvement of breast milk feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
mother own milk feeding rates
Measured: three years
Secondary outcomes (4)
NICU costs
costs during hospitalization in NICU
Measured: three years
the incidence of necrotizing enterocolitis (NEC)
the incidence of necrotizing enterocolitis
Measured: three years
the incidence of sepsis
Measured: three years
Reduce the incidence of enteral feed intolerance
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality ImprovementStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Maternity and Child Health Care Hospital, Jiangsu Women and Children Health Hospital, The First People's Hospital of Lianyungang, Xuzhou Maternity and Child Health Care Hospital, The Second Hospital of Nanjing Medical University, Children's Hospital of Nanjing Medical University, Suqian Maternity and Child Health Care Hospital, Lianyungang Maternity and Child Health Care Hospital, Wuxi Women's & Children's Hospital, Suzhou Municipal Hospital, Yancheng Maternity and Child Health Care Hospital, The First People's Hospital of Yancheng, The Affiliated Jiangyin Hospital of Southeast University Medical College, The First People's Hospital of Zhangjiagang, The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University, Huaian Maternity and Child Health Care Hospital, Changzhou Maternal and Child Care Hospital, Zhenjiang Maternity and Child Health Care Hospital, The Affiliated Hospital of Xuzhou Medical University, Jiangsu Taizhou People's Hospital, Affiliated Hospital of Jiangsu University, First People's Hospital of Hangzhou, Wuxi Maternity and Child Health Care Hospital, Changzhou Children's Hospital, Northern Jiangsu People's Hospital, Children's Hospital of Soochow University, Nantong Maternity and Child Health Care Hospital
- Responsible party
- Principal investigator, Zhangbin Yu, Nanjing Medical University
- Investigators
- Shuping Han, PhD, Study director, Nanjing Maternity and Child Health Care HospitalZhangbin Yu, PhD, Study director, Nanjing Maternity and Child Health Care HospitalJun Zhang, PhD, Principal investigator, Nanjing Maternity and Child Health Care HospitalYuhua Hu, PhD, Principal investigator, Jiangsu Women and Children Health HospitalShan Li, PhD, Principal investigator, The First People's Hospital of LianyungangXiaoyi Deng, PhD, Principal investigator, Xuzhou Maternity and Child Health Care HospitalZelin Jiao, PhD, Principal investigator, The Second Hospital of Nanjing Medical UniversityRui Cheng, PhD, Principal investigator, Children's Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453502
- Sponsor's protocol ID
- NMU-FY2017-350
- Status last verified
- Oct 2021
- First submitted
- 27 Feb 2018
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33190629
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mother Milk Feeding Benefits in Neonatal Intensive Care Units Using the Evidence-based Practice for Quality Improvement
- ClinicalTrials.gov ID
- NCT03453502
- Acronym / sponsor ID
- NMU-FY2017-350
- Conditions
- Quality Improvement, Breast Milk
- Keywords
- quality improvement, breast milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Nanjing Maternity and Child Health Care Hospital, Jiangsu Women and Children Health Hospital, The First People's Hospital of Lianyungang, Xuzhou Maternity and Child Health Care Hospital, The Second Hospital of Nanjing Medical University, Children's Hospital of Nanjing Medical University, Suqian Maternity and Child Health Care Hospital, Lianyungang Maternity and Child Health Care Hospital, Wuxi Women's & Children's Hospital, Suzhou Municipal Hospital, Yancheng Maternity and Child Health Care Hospital, The First People's Hospital of Yancheng, The Affiliated Jiangyin Hospital of Southeast University Medical College, The First People's Hospital of Zhangjiagang, The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University, Huaian Maternity and Child Health Care Hospital, Changzhou Maternal and Child Care Hospital, Zhenjiang Maternity and Child Health Care Hospital, The Affiliated Hospital of Xuzhou Medical University, Jiangsu Taizhou People's Hospital, Affiliated Hospital of Jiangsu University, First People's Hospital of Hangzhou, Wuxi Maternity and Child Health Care Hospital, Changzhou Children's Hospital, Northern Jiangsu People's Hospital, Children's Hospital of Soochow University, Nantong Maternity and Child Health Care Hospital
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Before-intervention phase | No intervention | –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. |
| Intervention phase | Experimental | Behavioral: Quality improvement of breast milk feedingAll 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. |
| Sustainability intervention phase | Experimental | Behavioral: Quality improvement of breast milk feedingAll 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. |
Who may qualify
- Ages
- Up to 120 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- premature Infants (Birth weight<1500g)
Key exclusion criteria (1 listed)
- mother with sever illness or communicable disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality improvement of breast milk feedingDuring the Intervention phase and Sustainability phase ,The NICUs will receive training of multiple evidence based quality improvement methods. | Behavioural | Intervention phase, Sustainability intervention phase |
Primary outcome
mother own milk feeding rates
Time frame: three years
4 secondary outcomes
NICU costs
Time frame: three years
the incidence of necrotizing enterocolitis (NEC)
Time frame: three years
the incidence of sepsis
Time frame: three years
Reduce the incidence of enteral feed intolerance
Time frame: three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Derived from this study: PubMed 33190629Xu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuping Han, PhD study director
Nanjing Maternity and Child Health Care Hospital
Zhangbin Yu, PhD study director
Nanjing Maternity and Child Health Care Hospital
Jun Zhang, PhD principal investigator
Nanjing Maternity and Child Health Care Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Quality improvement of breast milk feeding in people with Quality Improvement and Breast Milk, run by Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mother own milk feeding rates (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.