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Clinical Trials/NCT04531839
NCT04531839WithdrawnNot 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 countryStarted: October 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
6
Primary Endpoint
Mortality or any major morbidity

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
— to 120 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

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;

Arms & Interventions

Intervention period

Experimental

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

Intervention: Evidence-based collaborative quality improvement (Behavioral)

Baseline period

No Intervention

The 2-year period before the collaborative quality improvement intervention

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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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