Lung Ultrasound ScoresNCT03655457
Evaluation of the Efficacy of Surfaktant in Preterm Infants by Lung Ultrasound
A study testing group 1 Poractant alfa and group 2 beractant in people with Lung Ultrasound Scores, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
To compare the lung ultrasound scores after two different natural surfactant administration as a parameter reflecting lung inflation. Poractant alfa decreases lung ultrasound scores as efficient as beractant treatment Read more about this study
- Who is it for?
- Ages 1 hour to 6 hours
- Conditions the study is for
- Lung Ultrasound Scores
- What is being tested?
- group 1 Poractant alfa and group 2 beractant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2018to 28 Feb 2019
- Phase
- Interventional
- 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 hour to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants of 32 gestational weeks and below, who admit to the NICU with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.
Who cannot join
- major congenital anomalies.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Matarnity Teaching
Ankara, 06230
Davut Bozkaya, MD, +905053197531, drbozkaya@gmail.com
Şebnem Özyer, MD, +903123065272, sebnemsenozyer@yahoo.com,
About this study
Official title: Evaluation of the Efficacy of Different Surfactant Preparations in Preterm Infants by Lung Ultrasound
To compare the lung ultrasound scores after two different natural surfactant administration as a parameter reflecting lung inflation. Poractant alfa decreases lung ultrasound scores as efficient as beractant treatment
Read the detailed description
Outcomes:
Improvement of Lung usg scores after surfactanct and the difference between groups at different time points (2nd and 6hr).
Secondary outcome:
The correlation between lung usg scores and clinical scores (silverman scores), FiO2 and PCO2 levels, failure of weaning to noninvasive ventilation after surfactant Preterm infants of 32 gestational weeks and below, who admit to the NICU with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.
- Conditions
- Lung Ultrasound Scores
- Being tested
- group 1 Poractant alfa, group 2 beractant
- Keywords
- Lung, RDS, Surfaktant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group 1 Poractant alfaDevice
Comparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.
group 2 beractantDevice
lComparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.
| Study group | Role | What they receive |
|---|---|---|
| group 1 Poractant alfa | Experimental | Poractant alfa generic name: curosurf 120 and 240 mg flk dosage: 200 mg/ kg intratracheal application frequency and duration: in the first two hours Receives: Device: group 1 Poractant alfa |
| group 2 beractant | Active comparator | beractant generic name: survanta 8 cc flk dosage: 4 cc/ kg intratracheal application frequency and duration: in the first two hours Receives: Device: group 2 beractant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung usg scores
Evaluation of Lung Usg Scores in infants treated with surfactant in the first six hours (Brat lung usg scores). Each item scored 0-3. (0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.)
- Higher values represent a worse outcome
Measured: first days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start21 Mar 2018
- Primary completion30 Jan 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Ultrasound ScoresStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evrim Alyamaç Dizdar, MD, Study director, zekai tahir burak matarnity teaching hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655457
- Sponsor's protocol ID
- 22032018
- Status last verified
- Mar 2018
- First submitted
- 22 Mar 2018
- Last updated
- 11 Dec 2018
- 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 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Different Surfactant Preparations in Preterm Infants by Lung Ultrasound
- ClinicalTrials.gov ID
- NCT03655457
- Acronym / sponsor ID
- 22032018
- Conditions
- Lung Ultrasound Scores
- Keywords
- Lung, RDS, Surfaktant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 30 Jan 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 31 Aug 2018 (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.
To compare the lung ultrasound scores after two different natural surfactant administration as a parameter reflecting lung inflation. Poractant alfa decreases lung ultrasound scores as efficient as beractant treatment
Detailed description
Outcomes:
Improvement of Lung usg scores after surfactanct and the difference between groups at different time points (2nd and 6hr).
Secondary outcome:
The correlation between lung usg scores and clinical scores (silverman scores), FiO2 and PCO2 levels, failure of weaning to noninvasive ventilation after surfactant Preterm infants of 32 gestational weeks and below, who admit to the NICU with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 Poractant alfa | Experimental | Device: group 1 Poractant alfaPoractant alfa generic name: curosurf 120 and 240 mg flk dosage: 200 mg/ kg intratracheal application frequency and duration: in the first two hours |
| group 2 beractant | Active comparator | Device: group 2 beractantberactant generic name: survanta 8 cc flk dosage: 4 cc/ kg intratracheal application frequency and duration: in the first two hours |
Who may qualify
- Ages
- 1 hour to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants of 32 gestational weeks and below, who admit to the NICU with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.
Key exclusion criteria (1 listed)
- major congenital anomalies.
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 |
|---|---|---|
| group 1 Poractant alfaComparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations. | Device | group 1 Poractant alfa |
| group 2 beractantlComparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations. | Device | group 2 beractant |
Primary outcome
Lung usg scores
Time frame: first days
Evaluation of Lung Usg Scores in infants treated with surfactant in the first six hours (Brat lung usg scores). Each item scored 0-3. (0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.) - Higher values represent a worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
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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.
Evrim Alyamaç Dizdar, MD study director
zekai tahir burak matarnity teaching hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group 1 Poractant alfa and group 2 beractant in people with Lung Ultrasound Scores, run by Zekai Tahir Burak Women's Health Research and Education 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 1 inclusion and 1 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 11 Dec 2018. 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 Davut Bozkaya, MD (+905053197531, drbozkaya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung usg scores (time frame: first days). 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 11 Dec 2018.