MortalityNCT05381285
Survival Model for Preterm Infants
An observational study of Mortality and Morbidity;Newborn, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
Study Title Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period Internal ref. no. / short title Survival Model Study Design Observational Population-based Cohort Study Planned Sample Size Retrospective analysis of Database Planned Study Duration 6-months Primary Objectives To… Read more about this study
- Who is it for?
- Ages 0 to 16 weeks
- Conditions the study is for
- Mortality, Morbidity;Newborn
- How many people
- 5,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2024to Dec 2024
- 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 0 to 16 weeks
- All sexes
- No healthy volunteers
- Child
Study population: The whole population of preterm infants born before 34 weeks of gestation for 8 years (2011-2018) in Wales will be included in the retrospective cohort.
Who may be able to join
- Preterm infants born alive at or less than 34 weeks of gestation.
- Born in Welsh maternity and admitted for care to a Welsh neonatal unit.
- Mother normally resident in Wales
Who cannot join
- The mother is normally resident in England (detailed maternal data not available)
- Congenital anomaly noted at birth (alters the natural probability of outcomes)
- Duplicate episodes for an individual infant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital of Wales
Cardiff, CF14 4XW
Cathy Green
About this study
Official title: Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period (Survival Model)
Study Title Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period Internal ref. no. / short title Survival Model Study Design Observational Population-based Cohort Study Planned Sample Size Retrospective analysis of Database Planned Study Duration 6-months Primary Objectives To derive a mathematical model for predicting mortality and the composite of mortality/major-morbidity before and immediately after birth in preterm infants Secondary Objectives Statistical Methodology and Analysis Mixed-model multivariable logistic regression analysis
- Conditions
- Mortality, Morbidity;Newborn
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Non-interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In-hospital mortality
Measured: 40-weeks
Mortality or major morbidity
In-hospital outcomes
Measured: 40-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies of the same condition, open and under way.
- 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- Cardiff University, Swansea Bay University Health Board
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381285
- Sponsor's protocol ID
- 20/AUG/7966
- Other IDs
- 287049, 22/PR/0147
- Status last verified
- Aug 2023
- First submitted
- 1 Apr 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period (Survival Model)
- ClinicalTrials.gov ID
- NCT05381285
- Acronym / sponsor ID
- 20/AUG/7966
- Conditions
- Mortality, Morbidity;Newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- Cardiff University, Swansea Bay University Health Board
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 May 2022 (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.
Study Title Predictive Model of Mortality and Major Morbidity in Preterm Neonates in the Perinatal Period Internal ref. no. / short title Survival Model Study Design Observational Population-based Cohort Study Planned Sample Size Retrospective analysis of Database Planned Study Duration 6-months Primary Objectives To derive a mathematical model for predicting mortality and the composite of mortality/major-morbidity before and immediately after birth in preterm infants Secondary Objectives Statistical Methodology and Analysis Mixed-model multivariable logistic regression analysis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 16 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The whole population of preterm infants born before 34 weeks of gestation for 8 years (2011-2018) in Wales will be included in the retrospective cohort.
Key inclusion criteria (3 listed)
- Preterm infants born alive at or less than 34 weeks of gestation.
- Born in Welsh maternity and admitted for care to a Welsh neonatal unit.
- Mother normally resident in Wales
Key exclusion criteria (3 listed)
- The mother is normally resident in England (detailed maternal data not available)
- Congenital anomaly noted at birth (alters the natural probability of outcomes)
- Duplicate episodes for an individual infant
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 |
|---|---|---|
| No interventionNon-interventional study | Other | – |
Primary outcome
Mortality
Time frame: 40-weeks
In-hospital mortality
Mortality or major morbidity
Time frame: 40-weeks
In-hospital outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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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.
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 Mortality and Morbidity;Newborn, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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 3 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mallinath Chakraborty, PhD (+442921843387, chakrabortym@cardiff.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 40-weeks). 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 31 Aug 2023.