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Improving Outcome of Very Preterm Infants Using Collaborative Quality Improvement

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04531839
Enrollment
0
Registered
2020-08-31
Start date
2024-10-01
Completion date
2026-09-30
Last updated
2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morality, Morbidity;Newborn

Keywords

Very preterm infant, Quality improvement, Mortality, Morbidities

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.

Interventions

BEHAVIORALEvidence-based collaborative quality improvement

Evidence-based collaborative quality improvement interventions including benchmarking, potential better practice list, PDSA implementation and collaborative learning

Sponsors

Shanghai Children's Medical Center
CollaboratorOTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Obstetrics & Gynecology Hospital of Fudan University
CollaboratorOTHER
Shanghai First Maternity and Infant Hospital
CollaboratorOTHER
Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 120 Days
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Mortality or any major morbidityDuring 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

MeasureTime frameDescription
Bronchopulmonary dysplasiaDuring 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
Necrotizing enterocolitisDuring 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
Severe brain injuryDuring 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
MortalityDuring 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
Late-onset sepsisDuring 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 stayDuring first NICU hospitalization (about 1-4 months)days for the first NICU hospitalization
Retinopathy of prematurityDuring 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026