Improving Outcome of Very Preterm Infants Using Collaborative Quality Improvement

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04531839

Collaborator

Shanghai Children's Medical Center (Other), Shanghai First Maternity and Infant Hospital Tongji University School of Medicine (Other), Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other), Obstetrics & Gynecology Hospital of Fudan University (Other)

3,500

Enrollment

Locations

Arms

Anticipated Duration (Months)

583.3

Patients Per Site

48.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Morbidity;Newborn Morality	Behavioral: Evidence-based collaborative quality improvement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3500 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention period

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

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

No Intervention: Baseline period

The 2-year period before the collaborative quality improvement intervention

Outcome Measures

Primary Outcome Measures

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

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
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
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
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
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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 120 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Obstetrics and Gynecoloy Hospital of Fudan University	Shanghai	Shanghai	China	200011
2	Children's Hospital of Shanghai Jiao Tong University	Shanghai	Shanghai	China	200062
3	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200092
4	Shanghai First Maternity and Infant Hosipital	Shanghai	Shanghai	China	200126
5	Shanghai Children's Medical Center	Shanghai	Shanghai	China	200127
6	Children's Hospital of Fudan University	Shanghai	Shanghai	China	201102

Sponsors and Collaborators

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