MoralityNCT05116670
Comparison of Care Practices, Mortality and Morbidity of Very Preterm Infants Between Two Tertiary Centers in Northwest and South of China
An observational study of Morality and Morbidity;Newborn, run by Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Morality, Morbidity;Newborn, Very Preterm Maturity of Infant
- How many people
- 807 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Infants not born at QHH or SZH (out born);
- Infants who had major congenital anomalies;
- Infants admitted after 7 days of life.
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Baoan Women's and Children's Hospital
Shenzhen, Guangdong, 518000
About this study
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.
Read the 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.
- Conditions
- Morality, Morbidity;Newborn, Very Preterm Maturity of Infant
- Keywords
- care practices, mortality, morbidity, very preterm infant, comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
this is an observation study, no intervention is needed
| Study group | Role | What they receive |
|---|---|---|
| Qinghai Red Cross Hospital | Not described | |
| Shenzhen Baoan Women's and Children's Hospital | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
death during hospitalisation and death after withdrawing treatment
Measured: Jan 1,2018 - Dec 31,2020
Major morbidity
severe neurological injury, moderate to severe BPD, NEC or severe ROP
Measured: Jan 1,2018 - Dec 31,2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start15 Oct 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoralityStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 807 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhangbin Yu, The Second Clinical Medical College of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116670
- Sponsor's protocol ID
- NMU-FY2021-58
- Status last verified
- Feb 2022
- First submitted
- 31 Oct 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Care Practices, Mortality and Morbidity of Very Preterm Infants Between Two Tertiary Centers in Northwest and South of China
- ClinicalTrials.gov ID
- NCT05116670
- Acronym / sponsor ID
- NMU-FY2021-58
- Conditions
- Morality, Morbidity;Newborn, Very Preterm Maturity of Infant
- Keywords
- care practices, mortality, morbidity, very preterm infant, comparison
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 807 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qinghai Red Cross Hospital | – | – |
| Shenzhen Baoan Women's and Children's Hospital | – | – |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Infants not born at QHH or SZH (out born);
- Infants who had major congenital anomalies;
- Infants admitted after 7 days of life.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| this is an observation study, no intervention is needed | Other | Qinghai Red Cross Hospital, Shenzhen Baoan Women's and Children's Hospital |
Primary outcome
mortality
Time frame: Jan 1,2018 - Dec 31,2020
death during hospitalisation and death after withdrawing treatment
Major morbidity
Time frame: Jan 1,2018 - Dec 31,2020
severe neurological injury, moderate to severe BPD, NEC or severe ROP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morality and Morbidity;Newborn, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: Jan 1,2018 - Dec 31,2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.