Comparison of Care Practices, Mortality and Morbidity of Very Preterm Infants Between Two Tertiary Centers in Northwest and South of China

Sponsor

Nanjing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05116670

Collaborator

(none)

807

Enrollment

Location

2.5

Actual Duration (Months)

319

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Care practices, mortality and morbidity of very premature infants from two different tertiary centers were collected and compared, in order to discover areas for improvement where these two newborn centers can learn from each other.

Condition or Disease	Intervention/Treatment	Phase
Morality Morbidity;Newborn Very Preterm Maturity of Infant

Detailed Description

This retrospective cohort study was conducted in two hospitals,Qinghai Red Cross Hospital and Jinan University affiliated Shenzhen Baoan Women's and Children's Hospital.Very premature infants born with a gestational age between 22+0 - 31+6 weeks admitted to both centers during 3 years from January 1, 2018 to December 31, 2020 were studied. In both centers, data including maternal characteristics, neonatal characteristics, obstetric practices, delivery room practices, and neonatal outcomes, were collected by data abstractors in each NICU. Anonymous data was transferred to Shenzhen and analyses were performed at the newborn center of SZH.

Study Design

Study Type:

Observational

Actual Enrollment :

807 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Comparison of Care Practices, Mortality and Morbidity of Very Preterm Infants Between Two Tertiary Centers in Northwest and South of China

Actual Study Start Date :

Oct 15, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Qinghai Red Cross Hospital
Shenzhen Baoan Women's and Children's Hospital

Outcome Measures

Primary Outcome Measures

mortality [Jan 1,2018 - Dec 31,2020]
death during hospitalisation and death after withdrawing treatment
Major morbidity [Jan 1,2018 - Dec 31,2020]
severe neurological injury, moderate to severe BPD, NEC or severe ROP

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 28 Days

Sexes Eligible for Study:

All

Inclusion Criteria:

Very premature infants born with a gestational age between 22+0 - 31+6 weeks；
Admitted to both centers during 3 years from January 1, 2018 to December 31, 2020.

Exclusion Criteria:

Infants not born at QHH or SZH (out born);
Infants who had major congenital anomalies;
Infants admitted after 7 days of life.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shenzhen Baoan Women's and Children's Hospital	Shenzhen	Guangdong	China	518000

Sponsors and Collaborators

Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhangbin Yu, Clinical Professor#Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University

ClinicalTrials.gov Identifier:

NCT05116670

Other Study ID Numbers:

NMU-FY2021-58

First Posted:

Nov 11, 2021

Last Update Posted:

Mar 3, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Zhangbin Yu, Clinical Professor#Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Mar 3, 2022