Respiratory Distress SyndromeTeLaPLUSNCT06031324
The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress
An observational study of Respiratory Distress Syndrome and Lung Ultrasonography Score, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Respiratory distress in term and late preterm infants in the first hour after birth is a prevalent condition. This situation may occur due to different reasons such as minimal respiratory stress, transient tachypnea of newborn, respiratory distress syndrome, and congenital pneumonia. Read more about this study
- Who is it for?
- Ages 30 to 120 minutes
- Conditions the study is for
- Respiratory Distress Syndrome, Lung Ultrasonography Score
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2023to 28 Feb 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 30 to 120 minutes
- All sexes
- Child
Study population: Term and late-preterm premature newborns with respiratory distress symptoms in the first 30 minutes after birth
Who may be able to join
- Having symptoms of respiratory distress that begin soon after birth,
- > 34 gestational age,
- >1900 gr birth weight,
- Family consent
Who cannot join
- Congenital anomaly
- Chromosomal anomaly
- Hydrops fetalis
- Congenital heart disease
Trial locations and contacts
1 site in 1 country.
Ayten Erdoğan Ordu contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa City Hospital
Bursa
Bayram Ali Dorum, bayramalidorum@gmail.com
Ayten Erdogan Ordu
About this study
Respiratory distress in term and late preterm infants in the first hour after birth is a prevalent condition. This situation may occur due to different reasons such as minimal respiratory stress, transient tachypnea of newborn, respiratory distress syndrome, and congenital pneumonia. It can be not easy to distinguish this in the first hours. This study aimed to investigate the place of the lung ultrasonography score in the prognosis of these patients.
- Keywords
- Respiratory distress syndrome, Lung ultrasonography, Newborn
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment of a targeted number of patients
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start11 Nov 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bayram Ali DORUM, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031324
- Sponsor's protocol ID
- BCH-2023-14/2
- Acronym
- TeLaPLUS
- Status last verified
- Jul 2024
- First submitted
- 2 Sep 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress
- ClinicalTrials.gov ID
- NCT06031324
- Acronym / sponsor ID
- TeLaPLUS / BCH-2023-14/2
- Keywords
- Respiratory distress syndrome, Lung ultrasonography, Newborn
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 11 Sep 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.
Respiratory distress in term and late preterm infants in the first hour after birth is a prevalent condition. This situation may occur due to different reasons such as minimal respiratory stress, transient tachypnea of newborn, respiratory distress syndrome, and congenital pneumonia. It can be not easy to distinguish this in the first hours. This study aimed to investigate the place of the lung ultrasonography score in the prognosis of these patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 120 minutes
- Sex
- All
- Age groups
- Child
- Study population
- Term and late-preterm premature newborns with respiratory distress symptoms in the first 30 minutes after birth
Key inclusion criteria (4 listed)
- Having symptoms of respiratory distress that begin soon after birth,
- > 34 gestational age,
- >1900 gr birth weight,
- Family consent
Key exclusion criteria (4 listed)
- Congenital anomaly
- Chromosomal anomaly
- Hydrops fetalis
- Congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Enrollment of a targeted number of patients
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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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.
Ayten Erdoğan Ordu contact
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 Respiratory Distress Syndrome and Lung Ultrasonography Score, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
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 4 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 15 Jul 2024. 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 Turkey (Türkiye). 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 Bayram Ali Dorum (+905337078398, bayramalidorum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment of a targeted number of patients (time frame: 4 months). 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 15 Jul 2024.