Improving Outcome of Very Preterm Infants Using Collaborative Quality Improvement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving the Outcome of Very Preterm Infants Using Evidence-based Collaborative Quality Improvement: A Multi-center Prospective Study

Conditions
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Morbidity;Newborn, Morality

Intervention / Treatment
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* Behavioral: Evidence-based collaborative quality improvement


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Maximum Age: 120 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention period<br>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 | Behavioral: Evidence-based collaborative quality improvement<br>* Evidence-based collaborative quality improvement interventions including benchmarking, potential better practice list, PDSA implementation and collaborative learning<br>|
| No Intervention: Baseline period<br>The 2-year period before the collaborative quality improvement intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During first NICU hospitalization (about 1-4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During the procedure (about 1-4 months) | 
| 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 | During first NICU hospitalization (about 1-4 months) | 
| 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 | During first NICU hospitalization (about 1-4 months) | 
| 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 | During first NICU hospitalization (about 1-4 months) | 
| 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. | During first NICU hospitalization (about 1-4 months) | 
| 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 | During first NICU hospitalization (about 1-4 months) | 
| Length of NICU stay | days for the first NICU hospitalization | During first NICU hospitalization (about 1-4 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Very preterm infant, Quality improvement, Mortality, Morbidities