NeonatologyNCT05647850
Optimization and Clinical Study of Early Prediction Model for Neonatal Acute Respiratory Distress Syndrome
An observational study of Neonatology, run by University-Town Hospital of Chongqing Medical University at 2 sites in China.
Trial summary
The goal of this observational study is to learn about neonatal acute respiratory distress syndrome in describe participant population. The main question it aims to answer is: using perinatal factors to predict early neonatal acute respiratory distress syndrome and reduce its mortality. Read more about this study
- Who is it for?
- Ages 1 minute and olderHealthy volunteers can take part
- Conditions the study is for
- Neonatology
- How many people
- 2,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- 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 minute and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All infants from a multi-center study in China, will hospitalise between January 1, 2023 and December 31, 2025.
Who may be able to join
- A newborn born alive
Who cannot join
- Stillborn newborn
- Respiratory distress syndrome(RDS), transient tachypnoea of the neonate (TTN), or congenital anomalies as a primary current acute respiratory condition
- Hereditary endocrine and metabolic diseases
- Incomplete records
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
University-Town Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
Shuqing Tang
- Recruiting
Women and Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
Hui Liu
About this study
The goal of this observational study is to learn about neonatal acute respiratory distress syndrome in describe participant population. The main question it aims to answer is: using perinatal factors to predict early neonatal acute respiratory distress syndrome and reduce its mortality.
Participants' umbilical cord blood will be collected for testing, but will not receive any intervention.
- Conditions
- Neonatology
- Being tested
- No intervention
- Keywords
- Neonatal acute respiratory distress syndrome, Model of prediction, Perinatal factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Baseline characteristics of all patients | Not described Receives: Other: No intervention | |
| General characteristics of the patients. | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
General characteristics of the patients
Measured: 2023.1-2025.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start1 Jan 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeonatologyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University-Town Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Liu, University-Town Hospital of Chongqing Medical University
- Investigators
- Hui Liu, Principal investigator, University-Town Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647850
- Sponsor's protocol ID
- 123456
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization and Clinical Study of Early Prediction Model for Neonatal Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05647850
- Acronym / sponsor ID
- 123456
- Conditions
- Neonatology
- Keywords
- Neonatal acute respiratory distress syndrome, Model of prediction, Perinatal factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University-Town Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Dec 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.
The goal of this observational study is to learn about neonatal acute respiratory distress syndrome in describe participant population. The main question it aims to answer is: using perinatal factors to predict early neonatal acute respiratory distress syndrome and reduce its mortality.
Participants' umbilical cord blood will be collected for testing, but will not receive any intervention.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline characteristics of all patients | – | Other: No intervention |
| General characteristics of the patients. | – | Other: No intervention |
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All infants from a multi-center study in China, will hospitalise between January 1, 2023 and December 31, 2025.
Key inclusion criteria (1 listed)
- A newborn born alive
Key exclusion criteria (4 listed)
- Stillborn newborn
- Respiratory distress syndrome(RDS), transient tachypnoea of the neonate (TTN), or congenital anomalies as a primary current acute respiratory condition
- Hereditary endocrine and metabolic diseases
- Incomplete records
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 interventionNo intervention | Other | Baseline characteristics of all patients, General characteristics of the patients. |
Primary outcome
General characteristics of the patients
Time frame: 2023.1-2025.12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 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.
Hui Liu principal investigator
University-Town Hospital of Chongqing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatology, run by University-Town Hospital of Chongqing Medical University at 2 sites 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 1 inclusion and 4 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Liu (+8615223013501, liuhui8805@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General characteristics of the patients (time frame: 2023.1-2025.12). 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 7 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.