Quality ImprovementNCT04383379
To Improve the Rate of Mother's Own Milk Feeding of Premature Infants in NICU
A study testing Experimental: Intervention group in people with Quality Improvement and Breast-feeding, run by Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 120 days
- Conditions the study is for
- Quality Improvement, Breast-feeding, Premature Infant
- What is being tested?
- Experimental: Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2020to 30 Apr 2022
- 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
- Weight less than 1500g or gestational age less than 32 weeks;
- Admission to NICU.
Who cannot join
- Pregnancy with serious diseases, infectious diseases or other medical contraindications for breast-feeding (such as galactosemia);
- infants did not survive were excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
Han Shuping, PhD, +86-025-52226561, shupinghan@njmu.edu.cn
Yu Zhangbin, PhD, +86-025-52226567, zhangbinyu@njmu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Quality Improvement, Breast-feeding, Premature Infant
- Being tested
- Experimental: Intervention group
- Keywords
- Quality Improvement, breast-feeding, premature infant, cluster randomized controlled
- Medical subject headings
- Breast Feeding, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Intervention groupBehavioural
The intervention NICUs (n = 6) will receive training in the Evidence-based Practice for Improving Quality (EPIQ) method and then develop, implement, and document evidence-based practice changes toimprove the rate of breastfeeding . Compliance with practice changes and neonatal outcomes will be monitored. NICUs will receive quarterly feedback on their progress, as well as access to implementation support.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 6 NICUs in the intervention group . The participating units of the intervention group determine the improvement items (one or more) in each quarter from the list of best practices of breast feeding quality improvement of Jiangsu Province, and report the improvement plan to the supervision unit, and recommend the application of PDSA (plan-do-study-act) for the implementation of quality improvement loop. Report the implementation of quality improvement to the supervision unit on a quarterly basis. Receives: Behavioral: Experimental: Intervention group |
| control group | No intervention | Continue current practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
exclusive breastfeeding rate 24 hours before discharge
exclusive breastfeeding rate 24 hours before discharge
Measured: two years
Secondary outcomes (5)
Time of Mother's Own Milk at starting feed（hours）
Time of Mother's Own Milk at starting feed（hours）
Measured: two years
Proportion of first time Mother's Own Milk (%)
Proportion of first time Mother's Own Milk (%)
Measured: two years
Duration of parenteral nutrition (days)
Duration of parenteral nutrition (days)
Measured: two years
Time to total gastrointestinal feeding (days)
Time to total gastrointestinal feeding (days)
Measured: two years
Pump milk times (times /d) and amount (ml / d) ：1-3d, 4-7d ,8-14d
Pump milk times (times /d) and amount (ml / d) ：1-3d, 4-7d ,8-14d
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start15 May 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 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 Maternity and Child Health Care Hospital, Xuzhou Maternity and Child Health Care Hospital, Affiliated Hospital of Jiangsu University, Yangzhou Maternity and Child Health Care Hospital, Lianyungang Maternity and Child Health Care Hospital, Nantong Maternity and Child Health Care Hospital, The First People's Hospital of Jiangyin, Yangzhou No.1 People's Hospital, Subei people's Hospital, Wuxi Maternity and Child Health Care Hospital, The Affiliated Hospital of Xuzhou Medical University, Changzhou Maternal and Child Care Hospital
- Responsible party
- Principal investigator, Zhangbin Yu, Nanjing Medical University
- Investigators
- Han Shuping, PhD, Study director, Nanjing Maternity and Child Health Care HospitalYu Zhangbin, PhD, Study director, Nanjing Maternity and Child Health Care HospitalChen Xiaoqing, PhD, Principal investigator, Jiangsu Maternity and Child Health Care HospitalDeng Xiaoyi, PhD, Principal investigator, Xuzhou Maternity and Child Health Care HospitalLu Hongyan, PhD, Principal investigator, Affiliated Hospital of Jiangsu UniversityWu Xinping, PhD, Principal investigator, Yangzhou Maternity and Child Health Care HospitalGao Yan, PhD, Principal investigator, Lianyungang Maternity and Child Health Care HospitalLi Shuangshuang, PhD, Principal investigator, Nantong Maternity and Child Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383379
- Sponsor's protocol ID
- NMU-FY2016-73
- Status last verified
- Oct 2021
- First submitted
- 7 May 2020
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34819117
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
- 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
- ClinicalTrials.gov ID
- NCT04383379
- Acronym / sponsor ID
- NMU-FY2016-73
- Conditions
- Quality Improvement, Breast-feeding, Premature Infant
- Keywords
- Quality Improvement, breast-feeding, premature infant, cluster randomized controlled
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Nanjing Maternity and Child Health Care Hospital, Jiangsu Maternity and Child Health Care Hospital, Xuzhou Maternity and Child Health Care Hospital, Affiliated Hospital of Jiangsu University, Yangzhou Maternity and Child Health Care Hospital, Lianyungang Maternity and Child Health Care Hospital, Nantong Maternity and Child Health Care Hospital, The First People's Hospital of Jiangyin, Yangzhou No.1 People's Hospital, Subei people's Hospital, Wuxi Maternity and Child Health Care Hospital, The Affiliated Hospital of Xuzhou Medical University, Changzhou Maternal and Child Care Hospital
- Study start
- 15 May 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 12 May 2020 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Experimental: Intervention group6 NICUs in the intervention group . The participating units of the intervention group determine the improvement items (one or more) in each quarter from the list of best practices of breast feeding quality improvement of Jiangsu Province, and report the improvement plan to the supervision unit, and recommend the application of PDSA (plan-do-study-act) for the implementation of quality improvement loop. Report the implementation of quality improvement to the supervision unit on a quarterly basis. |
| control group | No intervention | –Continue current practices |
Who may qualify
- Ages
- Up to 120 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Weight less than 1500g or gestational age less than 32 weeks;
- Admission to NICU.
Key exclusion criteria (2 listed)
- Pregnancy with serious diseases, infectious diseases or other medical contraindications for breast-feeding (such as galactosemia);
- infants did not survive were excluded.
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 |
|---|---|---|
| Experimental: Intervention groupThe intervention NICUs (n = 6) will receive training in the Evidence-based Practice for Improving Quality (EPIQ) method and then develop, implement, and document evidence-based practice changes toimprove the rate of breastfeeding . Compliance with practice changes and neonatal outcomes will be monitored. NICUs will receive quarterly feedback on their progress, as well as access to implementation support. | Behavioural | Intervention group |
Primary outcome
exclusive breastfeeding rate 24 hours before discharge
Time frame: two years
exclusive breastfeeding rate 24 hours before discharge
5 secondary outcomes
Time of Mother's Own Milk at starting feed（hours）
Time frame: two years
Proportion of first time Mother's Own Milk (%)
Time frame: two years
Duration of parenteral nutrition (days)
Time frame: two years
Time to total gastrointestinal feeding (days)
Time frame: two years
Pump milk times (times /d) and amount (ml / d) ：1-3d, 4-7d ,8-14d
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Derived from this study: PubMed 34819117Huo 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.
Related trials for Quality Improvement
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruiting
Evaluation of an AI-Assisted Tool for CLABSI Surveillance at VA Medical Centers
Central Line-Associated Bloodstream Infection (CLABSI), Bacteremia
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
Not yet recruitingPhase 2
Phase 2 Evaluation of Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB) Injection for the Treatment of Infraorbital Hollowing
Infra-orbital Hollows, Skin Quality Improvement
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia
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.
Han Shuping, PhD study director
Nanjing Maternity and Child Health Care Hospital
Yu Zhangbin, PhD study director
Nanjing Maternity and Child Health Care Hospital
Chen Xiaoqing, PhD principal investigator
Jiangsu Maternity and Child Health Care Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Intervention group in people with Quality Improvement and Breast-feeding, run by Nanjing Medical University at 1 site in China.
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 2 inclusion and 2 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: status not confirmed, 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.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Shuping, PhD (+86-025-52226561, shupinghan@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exclusive breastfeeding rate 24 hours before discharge (time frame: two 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 NCT04383379, 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.