Improving Outcome of Very Preterm Infants Using Collaborative Quality Improvement

Not Applicable

Withdrawn

• Conditions: Morbidity;Newborn; Morality

• Registration Number: NCT04531839
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Study Start: 2024-10-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Infants born at >=24+0 weeks' gestation and <32+0 weeks' gestation;
2. Admitted to the participating NICUs within 7 days after birth during study period

Exclusion Criteria

1. Infants with major congenital anomalies;
2. Infants who transferred to non-participating hospitals within 24 hours after birth;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Mortality or any major morbidity	During first NICU hospitalization (about 1-4 months)	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

Name	Time	Method
Late-onset sepsis	During first NICU hospitalization (about 1-4 months)	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	During first NICU hospitalization (about 1-4 months)	days for the first NICU hospitalization
Necrotizing enterocolitis	During first NICU hospitalization (about 1-4 months)	It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with NEC stage II or above
Retinopathy of prematurity	During first NICU hospitalization (about 1-4 months)	It is a binary varibale (1/0). The variabel would be setted into "1",if patients appeared with ROP stage III or above.
Mortality	During the procedure (about 1-4 months)	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
Severe brain injury	During first NICU hospitalization (about 1-4 months)	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
Bronchopulmonary dysplasia	During first NICU hospitalization (about 1-4 months)	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

Trial Locations

Locations (6)

Obstetrics and Gynecoloy Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

Children's Hospital of Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Shanghai First Maternity and Infant Hosipital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Children's Medical Center; 🇨🇳 Shanghai, Shanghai, China

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China