Back to resultsImproving Outcome of Very Preterm Infants Using Collaborative Quality Improvement
Primary Purpose
Morbidity;Newborn, Morality
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Evidence-based collaborative quality improvement
Sponsored by
About this trial
This is an interventional health services research trial for Morbidity;Newborn focused on measuring Very preterm infant, Quality improvement, Mortality, Morbidities
Eligibility Criteria
Inclusion Criteria:
- Infants born at >=24+0 weeks' gestation and <32+0 weeks' gestation;
- Admitted to the participating NICUs within 7 days after birth during study period
Exclusion Criteria:
- Infants with major congenital anomalies;
- Infants who transferred to non-participating hospitals within 24 hours after birth;
Sites / Locations
- Obstetrics and Gynecoloy Hospital of Fudan University
- Children's Hospital of Shanghai Jiao Tong University
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- Shanghai First Maternity and Infant Hosipital
- Shanghai Children's Medical Center
- Children's Hospital of Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention period
Baseline period
Arm Description
The 1.5-year period during which all six participating centers receive evidence-based collaborative quality improvement interventions including benchmarking, potential better practice list, PDSA implementation, and collaborative learning
The 2-year period before the collaborative quality improvement intervention
Outcomes
Primary Outcome Measures
Mortality or any major morbidity
It is a binary varibale (1/0). The variabel would be setted into "1",if death or with any of the following major morbidities: bronchopulmonary dysplasia, necrotizing stage II or above, retinopathy of prematurity stage III or above, intraventricular hemorrhage grade III or above or cystic periventricular leukomalacia and late-onset epsis
Secondary Outcome Measures
Mortality
It is a binary varibale (1/0). The variabel would be setted into "1",if patients dead during hospitalization or 28 days after discharge against medical advice
Bronchopulmonary dysplasia
It is a binary varibale (1/0). The variabel would be setted into "1",if patients reveived respiratory support or oxygen at 36 weeks' corrected gestational age or on discharge
Necrotizing enterocolitis
It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with NEC stage II or above
Severe brain injury
It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with intraventricular hemorrhage grade III or above within 28 days after birth or cystic periventricular leukomalacia
Retinopathy of prematurity
It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with ROP stage III or above.
Late-onset sepsis
It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with culture-proven sepsis after 72 hours after birth
Length of NICU stay
days for the first NICU hospitalization
Full Information
NCT ID
NCT04531839
First Posted
August 26, 2020
Last Updated
August 29, 2023
Sponsor
Children's Hospital of Fudan University
Collaborators
Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Obstetrics & Gynecology Hospital of Fudan University, Shanghai First Maternity and Infant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04531839
Brief Title
Improving Outcome of Very Preterm Infants Using Collaborative Quality Improvement
Official Title
Improving the Outcome of Very Preterm Infants Using Evidence-based Collaborative Quality Improvement: A Multi-center Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Obstetrics & Gynecology Hospital of Fudan University, Shanghai First Maternity and Infant Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A multicenter interventional study using evidence-based collaborative quality improvement to reduce mortality and major morbidities of very preterm infants in six neonatal centers in Shanghai
Detailed Description
A multicenter interventional study using evidence-based collaborative quality improvement to reduce mortality and major morbidities of very preterm infants using evidence-based collaborative quality improvement interventions including benchmarking, potential better practice list, PDSA implementation and collaborative learning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbidity;Newborn, Morality
Keywords
Very preterm infant, Quality improvement, Mortality, Morbidities
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention period
Arm Type
Experimental
Arm Description
The 1.5-year period during which all six participating centers receive evidence-based collaborative quality improvement interventions including benchmarking, potential better practice list, PDSA implementation, and collaborative learning
Arm Title
Baseline period
Arm Type
No Intervention
Arm Description
The 2-year period before the collaborative quality improvement intervention
Intervention Type
Behavioral
Intervention Name(s)
Evidence-based collaborative quality improvement
Intervention Description
Evidence-based collaborative quality improvement interventions including benchmarking, potential better practice list, PDSA implementation and collaborative learning
Primary Outcome Measure Information:
Title
Mortality or any major morbidity
Description
It is a binary varibale (1/0). The variabel would be setted into "1",if death or with any of the following major morbidities: bronchopulmonary dysplasia, necrotizing stage II or above, retinopathy of prematurity stage III or above, intraventricular hemorrhage grade III or above or cystic periventricular leukomalacia and late-onset epsis
Time Frame
During first NICU hospitalization (about 1-4 months)
Secondary Outcome Measure Information:
Title
Mortality
Description
It is a binary varibale (1/0). The variabel would be setted into "1",if patients dead during hospitalization or 28 days after discharge against medical advice
Time Frame
During the procedure (about 1-4 months)
Title
Bronchopulmonary dysplasia
Description
It is a binary varibale (1/0). The variabel would be setted into "1",if patients reveived respiratory support or oxygen at 36 weeks' corrected gestational age or on discharge
Time Frame
During first NICU hospitalization (about 1-4 months)
Title
Necrotizing enterocolitis
Description
It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with NEC stage II or above
Time Frame
During first NICU hospitalization (about 1-4 months)
Title
Severe brain injury
Description
It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with intraventricular hemorrhage grade III or above within 28 days after birth or cystic periventricular leukomalacia
Time Frame
During first NICU hospitalization (about 1-4 months)
Title
Retinopathy of prematurity
Description
It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with ROP stage III or above.
Time Frame
During first NICU hospitalization (about 1-4 months)
Title
Late-onset sepsis
Description
It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with culture-proven sepsis after 72 hours after birth
Time Frame
During first NICU hospitalization (about 1-4 months)
Title
Length of NICU stay
Description
days for the first NICU hospitalization
Time Frame
During first NICU hospitalization (about 1-4 months)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
120 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants born at >=24+0 weeks' gestation and <32+0 weeks' gestation;
Admitted to the participating NICUs within 7 days after birth during study period
Exclusion Criteria:
Infants with major congenital anomalies;
Infants who transferred to non-participating hospitals within 24 hours after birth;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Cao, MD,PHD
Phone
862164931990
Ext
1160
Email
yuncao@fudan.edu.cn
Facility Information:
Facility Name
Obstetrics and Gynecoloy Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Children's Hospital of Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200062
Country
China
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Shanghai First Maternity and Infant Hosipital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200126
Country
China
Facility Name
Shanghai Children's Medical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
25946279
Citation
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Results Reference
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PubMed Identifier
28232518
Citation
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Results Reference
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PubMed Identifier
31167207
Citation
Soll RF, McGuire W. Evidence-Based Practice: Improving the Quality of Perinatal Care. Neonatology. 2019;116(3):193-198. doi: 10.1159/000496214. Epub 2019 Jun 5.
Results Reference
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PubMed Identifier
27381936
Citation
Zeitlin J, Manktelow BN, Piedvache A, Cuttini M, Boyle E, van Heijst A, Gadzinowski J, Van Reempts P, Huusom L, Weber T, Schmidt S, Barros H, Dillalo D, Toome L, Norman M, Blondel B, Bonet M, Draper ES, Maier RF; EPICE Research Group. Use of evidence based practices to improve survival without severe morbidity for very preterm infants: results from the EPICE population based cohort. BMJ. 2016 Jul 5;354:i2976. doi: 10.1136/bmj.i2976.
Results Reference
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Citation
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Results Reference
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Improving Outcome of Very Preterm Infants Using Collaborative Quality Improvement
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