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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05116670
Other study ID # NMU-FY2021-58
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 15, 2021
Est. completion date December 31, 2021

Study information

Verified date February 2022
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 807
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group N/A to 28 Days
Eligibility 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.

Study Design


Locations

Country Name City State
China Shenzhen Baoan Women's and Children's Hospital Shenzhen Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary mortality death during hospitalisation and death after withdrawing treatment Jan 1,2018 - Dec 31,2020
Primary Major morbidity severe neurological injury, moderate to severe BPD, NEC or severe ROP Jan 1,2018 - Dec 31,2020
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