NCT05116670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
807

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2021

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 31, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

October 31, 2021

Last Update Submit

February 14, 2022

Conditions

Keywords

care practicesmortalitymorbidityvery preterm infantcomparison

Outcome Measures

Primary Outcomes (2)

  • mortality

    death during hospitalisation and death after withdrawing treatment

    Jan 1,2018 - Dec 31,2020

  • Major morbidity

    severe neurological injury, moderate to severe BPD, NEC or severe ROP

    Jan 1,2018 - Dec 31,2020

Study Arms (2)

Qinghai Red Cross Hospital

Shenzhen Baoan Women's and Children's Hospital

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Very premature infants born with a gestational age between 22+0 - 31+6 weeks admitted to newborn centers of Qinghai Red Cross Hospital and Shenzhen Baoan Women's and Children's Hospital from Jan 1, 2018 to Dec 31, 2020.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Baoan Women's and Children's Hospital

Shenzhen, Guangdong, 518000, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor#Shenzhen People's Hospital

Study Record Dates

First Submitted

October 31, 2021

First Posted

November 11, 2021

Study Start

October 15, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 3, 2022

Record last verified: 2022-02

Locations