Respiratory Distress SyndromeNCT05772247
Predictive Value of PS Application in Premature Infants With RDS
An observational study of Respiratory Distress Syndrome, run by The First Hospital of Jilin University.
Trial summary
A multicenter prospective study was conducted to compare the predictive value of 6-zone, 10-zone, and 12-zone LUS scores for PS application in early and late preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Lung ultrasound
- How many people
- 1,392 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 31 Dec 2023
- 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 1 month
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants <37 weeks gestational age
Who may be able to join
- Hospital admission within 2 hours after birth;
- The diagnosis was RDS;
- Parents agree to attend
Who cannot join
- chromosomal abnormalities or complex congenital malformations;
- congenital pulmonary disease;
- severe sepsis, disseminated intravascular coagulation, septic shock and other critical conditions;
- LUS and blood gas analysis have been examined before the application of alveolar surfactant.
About this study
Official title: Predictive Value of PS Application in Premature Infants With RDS by Different Pulmonary Ultrasound Scores: a Prospective Multicenter Study
A multicenter prospective study was conducted to compare the predictive value of 6-zone, 10-zone, and 12-zone LUS scores for PS application in early and late preterm infants.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Lung ultrasound
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
Lung ultrasound score was calculated by the results of lung ultrasound examination
| Study group | Role | What they receive |
|---|---|---|
| PS application | Not described Receives: Diagnostic Test: Lung ultrasound | |
| non-PS application | Not described Receives: Diagnostic Test: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether the patient uses ps (pulmonary surfactant)
The standards used by PS are based on the European consensus
Measured: 2023.2-2023.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Prospective
- Enrolment
- 1,392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772247
- Sponsor's protocol ID
- FirstJilinU2
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of PS Application in Premature Infants With RDS by Different Pulmonary Ultrasound Scores: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT05772247
- Acronym / sponsor ID
- FirstJilinU2
- Conditions
- Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,392 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Mar 2023 (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.
A multicenter prospective study was conducted to compare the predictive value of 6-zone, 10-zone, and 12-zone LUS scores for PS application in early and late preterm infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PS application | – | Diagnostic Test: Lung ultrasound |
| non-PS application | – | Diagnostic Test: Lung ultrasound |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants <37 weeks gestational age
Key inclusion criteria (3 listed)
- Hospital admission within 2 hours after birth;
- The diagnosis was RDS;
- Parents agree to attend
Key exclusion criteria (4 listed)
- chromosomal abnormalities or complex congenital malformations;
- congenital pulmonary disease;
- severe sepsis, disseminated intravascular coagulation, septic shock and other critical conditions;
- LUS and blood gas analysis have been examined before the application of alveolar surfactant.
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 |
|---|---|---|
| Lung ultrasoundLung ultrasound score was calculated by the results of lung ultrasound examination | Diagnostic test | PS application, non-PS application |
Primary outcome
Whether the patient uses ps (pulmonary surfactant)
Time frame: 2023.2-2023.12
The standards used by PS are based on the European consensus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, run by The First Hospital of Jilin University.
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 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 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Whether the patient uses ps (pulmonary surfactant) (time frame: 2023.2-2023.12). 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 16 Mar 2023.