Skip to main content
Clinical Trials/NCT04531839
NCT04531839
Withdrawn
Not Applicable

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

Children's Hospital of Fudan University6 sites in 1 countryOctober 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbidity;Newborn
Sponsor
Children's Hospital of Fudan University
Locations
6
Primary Endpoint
Mortality or any major morbidity
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
September 30, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

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;

Outcomes

Primary Outcomes

Mortality or any major morbidity

Time Frame: 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 Outcomes

  • Late-onset sepsis(During first NICU hospitalization (about 1-4 months))
  • Length of NICU stay(During first NICU hospitalization (about 1-4 months))
  • Necrotizing enterocolitis(During first NICU hospitalization (about 1-4 months))
  • Retinopathy of prematurity(During first NICU hospitalization (about 1-4 months))
  • Mortality(During the procedure (about 1-4 months))
  • Severe brain injury(During first NICU hospitalization (about 1-4 months))
  • Bronchopulmonary dysplasia(During first NICU hospitalization (about 1-4 months))

Study Sites (6)

Loading locations...

Similar Trials