Respiratory Distress SyndromeNCT04544514
Earliest Lung Ultrasound Time for Predicting the Need of Surfactant
An observational study of Respiratory Distress Syndrome, run by Gozdem Kayki.
Trial summary
Lung ultrasonography (LUS) is fast and easy technique. it also has high reliability, so it has started to be used more in evaluating respiratory distress in the neonatal period. The most important feature of LUS is being radiation-free. Three LUS findings that show respiratory distress syndrome were described. Read more about this study
- Who is it for?
- Ages 30 minutes to 6 hours
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- lung ultrasound
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2019
- How long will I take part?
- 1 Day
- 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 minutes to 6 hours
- All sexes
- No healthy volunteers
- Child
Study population: extreme preterm babies with a gestational age 32 weeks or less were admitted to NICU. Only babies who were treated with CPAP because of clinical signs of respiratory distress were enrolled the study.
Who may be able to join
- preterm babies with a gestational age 32 weeks or less
- babies treated with CPAP
Who cannot join
- If a baby was intubated in delivery room because of the responsiveness to face-mask ventilation, he/she was excluded.
- congenital heart diseases
- complex congenital malformations
- chromosomal abnormalities.
About this study
Lung ultrasonography (LUS) is fast and easy technique. it also has high reliability, so it has started to be used more in evaluating respiratory distress in the neonatal period. The most important feature of LUS is being radiation-free. Three LUS findings that show respiratory distress syndrome were described. They were white lung appearance, lack of preserved areas and loss of pleural integrity. The sensitivity of these findings was found to be 98-100% and the specificity 92-100%. A few studies have shown that surfactant need can be determined by LUS.
It was observed that lung findings were more severe in LUS performed in the early period because of non-completed fetal lung fluid clearence, but the findings could be improved during follow-up. Therefore, it is not known when the earliest time of LUS shows the actual clinical condition and course of the patient.
This study was planned to find the most reliable and earliest US time. Evaluation with LUS was done at 30 minutes and repeated at 1, 2, 4 and 6 hours of life. The LUS findings would be compared with x-ray findings and the correlation of surfactant need with LUS findings would also be investigated.
- 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
LUS was performed within first 20 to 30 minutes and repeated at 1, 2, 4 and 6 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
lung ultrasound at 30 minutes
lung ultrasound findings
Measured: 30 minutes
lung ultrasound at 1 hour
lung ultrasound findings
Measured: 1 hour
lung ultrasound at 2 hour
lung ultrasound findings
Measured: 2 hour
lung ultrasound at 4 hour
lung ultrasound findings
Measured: 4 hour
lung ultrasound at 6 hour
lung ultrasound findings
Measured: 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gozdem Kayki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gozdem Kayki, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544514
- Sponsor's protocol ID
- go 20 334
- Status last verified
- Sep 2020
- First submitted
- 3 Sep 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kayki G, Yigit S, Tandircioglu UA, Celik HT, Yurdakok M. Lung ultrasound (LUS) and surfactant treatment: looking for the best predictive moment. J Perinatol. 2021 Jul;41(7):1669-1674. doi: 10.1038/s41372-021-01039-0. Epub 2021 Mar 23.
PubMed 33758395
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Earliest Lung Ultrasound Time for Predicting the Need of Surfactant
- ClinicalTrials.gov ID
- NCT04544514
- Acronym / sponsor ID
- go 20 334
- Conditions
- Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Gozdem KaykiUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Sep 2020 (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.
Lung ultrasonography (LUS) is fast and easy technique. it also has high reliability, so it has started to be used more in evaluating respiratory distress in the neonatal period. The most important feature of LUS is being radiation-free. Three LUS findings that show respiratory distress syndrome were described. They were white lung appearance, lack of preserved areas and loss of pleural integrity. The sensitivity of these findings was found to be 98-100% and the specificity 92-100%. A few studies have shown that surfactant need can be determined by LUS.
It was observed that lung findings were more severe in LUS performed in the early period because of non-completed fetal lung fluid clearence, but the findings could be improved during follow-up. Therefore, it is not known when the earliest time of LUS shows the actual clinical condition and course of the patient.
This study was planned to find the most reliable and earliest US time. Evaluation with LUS was done at 30 minutes and repeated at 1, 2, 4 and 6 hours of life. The LUS findings would be compared with x-ray findings and the correlation of surfactant need with LUS findings would also be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 30 minutes to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- extreme preterm babies with a gestational age 32 weeks or less were admitted to NICU. Only babies who were treated with CPAP because of clinical signs of respiratory distress were enrolled the study.
Key inclusion criteria (2 listed)
- preterm babies with a gestational age 32 weeks or less
- babies treated with CPAP
Key exclusion criteria (4 listed)
- If a baby was intubated in delivery room because of the responsiveness to face-mask ventilation, he/she was excluded.
- congenital heart diseases
- complex congenital malformations
- chromosomal abnormalities.
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 ultrasoundLUS was performed within first 20 to 30 minutes and repeated at 1, 2, 4 and 6 hours. | Diagnostic test | – |
Primary outcome
lung ultrasound at 30 minutes
Time frame: 30 minutes
lung ultrasound findings
lung ultrasound at 1 hour
Time frame: 1 hour
lung ultrasound findings
lung ultrasound at 2 hour
Time frame: 2 hour
lung ultrasound findings
lung ultrasound at 4 hour
Time frame: 4 hour
lung ultrasound findings
lung ultrasound at 6 hour
Time frame: 6 hour
lung ultrasound findings
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 11 Sep 2020.
- Derived from this study: PubMed 33758395Kayki G, Yigit S, Tandircioglu UA, Celik HT, Yurdakok M. Lung ultrasound (LUS) and surfactant treatment: looking for the best predictive moment. J Perinatol. 2021 Jul;41(7):1669-1674. doi: 10.1038/s41372-021-01039-0. Epub 2021 Mar 23.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, run by Gozdem Kayki.
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 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: finished, as of the sponsor's last update on 11 Sep 2020. 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?
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?
lung ultrasound at 30 minutes (time frame: 30 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04544514, which also lists 1 linked publication.
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 11 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.