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AzTrials

Newborn ComplicationNCT06880016

Evaluation of Serial Lung Ultrasound Data After Surfactant Treatments Applied With Different Methods in Preterm Babies

A study testing Evaluation of serial lung ultrasound data after ENSURE surfactant treatments and Evaluation of serial lung ultrasound data after LISA surfactant treatments in people with Newborn Complication and Respiratory Distress Syndrome, Newborn, run by Konya City Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to investigate the relationship between the method of surfactant administration and improvements in serial lung ultrasound findings in preterm infants requiring surfactant therapy. Read more about this study

Who is it for?
Ages 1 day to 5 days
What is being tested?
Evaluation of serial lung ultrasound data after ENSURE surfactant treatments and Evaluation of serial lung ultrasound data after LISA surfactant treatments
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jul 2024to 1 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 5 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infants of families who agree to participate in the study
  • Preterm infants born before 32 weeks of gestation requiring surfactant therapy due to an RDS diagnosis.

Who cannot join

  • Infants whose families did not provide consent
  • Infants with a syndromic appearance or congenital heart disease
  • Preterm infants born after 32 weeks of gestation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Melek Buyukeren

    Konya, Karatay, 42020

    MELEK BUYUKEREN, +903323105000, melekbuyukeren@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

This study aims to investigate the relationship between the method of surfactant administration and improvements in serial lung ultrasound findings in preterm infants requiring surfactant therapy.

Read the detailed description

In the neonatal intensive care unit, lung ultrasound was first used for the diagnosis of neonatal respiratory distress syndrome (RDS) by Avni et al. in 1990. Following this, lung ultrasound rapidly became widespread in neonatal intensive care units and was seen as a potential alternative to chest X-rays. It is now frequently used in cases of RDS, transient tachypnea of the newborn, pneumonia, and pneumothorax. Lung ultrasound has high specificity, sensitivity, positive predictive value, and negative predictive value. It is performed quickly at the bedside, allowing for rapid diagnosis and timely intervention.

Respiratory distress syndrome is one of the most common causes of morbidity and mortality in preterm infants. It results from a surfactant deficiency in the lungs secondary to preterm birth. Early diagnosis and timely administration of intratracheal surfactant, which is the only definitive treatment, are crucial. The diagnosis has traditionally relied on chest X-rays, but with recent advancements, lung ultrasound has also become a diagnostic tool. In addition to diagnosing RDS, lung ultrasound plays a critical role in its differential diagnosis, severity classification, and management in neonates.

Different methods can be used for the intratracheal administration of surfactant in the treatment of neonatal respiratory distress syndrome. Surfactant can be administered through an endotracheal tube in intubated infants. In non-intubated infants, two commonly accepted and frequently used methods are available. The first method involves intubating the infant, administering intratracheal surfactant, and then extubating them back to nasal respiratory support (ENSURE method). The second method involves delivering surfactant via a thin catheter (5F) directly into the trachea while the infant remains on existing nasal respiratory support, without disconnecting them from it (LISA method). Both of these methods are frequently used in neonatal intensive care units, and multiple studies comparing them indicate no clear superiority of one over the other.

Many studies utilizing lung ultrasound incorporate lung ultrasound scoring systems. The first neonatal lung ultrasound score was defined by Brat et al. Each lung is divided into three regions (upper anterior, lower anterior, and lateral), and each region is assigned a score from 0 to 3:

0 points: Defined by the presence of only A-lines.

  1. point: Defined by the presence of three or more well-spaced B-lines.
  2. points: Defined by the presence of multiple coalescing B-lines, with or without small subpleural consolidations.
  3. points: Defined by the presence of large consolidation areas. The total score, obtained by summing the scores from all lung regions, represents the infant's overall lung ultrasound score. Scores range from 0 (completely normal) to 18.

Based on existing lung ultrasound studies, this study will evaluate preterm infants born before 32 weeks gestation who are diagnosed with RDS. Serial lung ultrasounds will be performed at different time points following surfactant administration (5 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, and 6 hours after completion of surfactant administration), and lung ultrasound scores will be calculated. The aim is to determine whether different surfactant administration methods result in different lung ultrasound scores over time.

This study aims to investigate the relationship between the method of surfactant administration and improvements in serial lung ultrasound findings in preterm infants requiring surfactant therapy.

The investigators plan to conduct their study at Konya City Hospital between July 2024 and July 2025. Preterm infants born at their hospital at or below 32 weeks of gestation, diagnosed with RDS, and requiring surfactant therapy without intubation will be included in the study. The families of the infants planned for inclusion will be informed about the study, and written consent will be obtained if they agree to participate. Only infants whose families provide consent will be included. The follow-up process and treatments of the included infants will not be altered in any way. The method of surfactant administration will be determined by the attending neonatologist. The physician performing the ultrasound evaluations and the principal investigator will be blinded to the method of surfactant administration. The choice of surfactant administration method will be made solely by the responsible physician.

A total of seven serial lung ultrasound evaluations will be performed at 5 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, and 6 hours after the completion of surfactant administration. Lung ultrasound scoring will be applied (each lung is divided into three regions: upper anterior, lower anterior, and lateral. Each region is assigned a score from 0 to 3: 0 points indicate the presence of only A-lines; 1 point indicates the presence of ≥3 well-spaced B-lines; 2 points indicate multiple coalescent B-lines, with or without subpleural consolidations; and 3 points indicate large consolidation areas). All ultrasound evaluations throughout the study will be performed by the same physician.

The demographic and clinical characteristics of the patients, as well as prenatal/postnatal risk factors, will be recorded in the patient data collection form. Additionally, ultrasound scoring results, oxygen requirements, and saturation values will be documented.

No invasive procedures will be performed on the patients, and no blood samples will be collected for the study.

Being tested
Evaluation of serial lung ultrasound data after ENSURE surfactant treatments, Evaluation of serial lung ultrasound data after LISA surfactant treatments
Keywords
NEWBORN, Respiratory Distress Syndrome, surfactant
Medical subject headings
Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of serial lung ultrasound data after ENSURE surfactant treatmentsDiagnostic test

    Intubating the infant, administering intratracheal surfactant, and then extubating them back to nasal respiratory support (ENSURE method)

  • Evaluation of serial lung ultrasound data after LISA surfactant treatmentsDiagnostic test

    Delivering surfactant via a thin catheter (5F) directly into the trachea while the infant remains on existing nasal respiratory support, without disconnecting them from it (LISA method)

Study groups in NCT06880016
Study groupRoleWhat they receive
Ensure groupExperimentalThe first method involves intubating the infant, administering intratracheal surfactant, and then extubating them back to nasal respiratory support (ENSURE method).
Receives: Diagnostic Test: Evaluation of serial lung ultrasound data after ENSURE surfactant treatments
Lisa groupExperimentalThe second method involves delivering surfactant via a thin catheter (5F) directly into the trachea while the infant remains on existing nasal respiratory support, without disconnecting them from it (LISA method).
Receives: Diagnostic Test: Evaluation of serial lung ultrasound data after LISA surfactant treatments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of serial lung ultrasound data after surfactant treatments

    This study aims to investigate the relationship between the method of surfactant administration and improvements in serial lung ultrasound findings in preterm infants requiring surfactant therapy.

    Measured: 6 hours after completion of surfactant administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2025
  2. Study start1 Jul 2024
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The first method involves intubating the infant, administering intratracheal surfactant, and then extubating them back to nasal respiratory support (ENSURE method). The second method involves delivering surfactant via a thin catheter (5F) directly into the trachea while the infant remains on existing nasal respiratory support, without disconnecting them from it (LISA method).
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06880016
Sponsor's protocol ID
KSH_MB_2025_3
Status last verified
Jul 2026
First submitted
11 Mar 2025
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Once the study is published as a scientific article, it can be shared.

Publications

  • Avni EF, Braude P, Pardou A, Matos C. Hyaline membrane disease in the newborn: diagnosis by ultrasound. Pediatr Radiol. 1990;20(3):143-6. doi: 10.1007/BF02012957.

    PubMed 2191263
  • Corsini I, Parri N, Gozzini E, Coviello C, Leonardi V, Poggi C, Giacalone M, Bianconi T, Tofani L, Raimondi F, Dani C. Lung Ultrasound for the Differential Diagnosis of Respiratory Distress in Neonates. Neonatology. 2019;115(1):77-84. doi: 10.1159/000493001. Epub 2018 Oct 10.

    PubMed 30304736
  • Liu X, Si S, Guo Y, Wu H. Limitations of Bedside Lung Ultrasound in Neonatal Lung Diseases. Front Pediatr. 2022 Apr 26;10:855958. doi: 10.3389/fped.2022.855958. eCollection 2022.

    PubMed 35558371
  • Singh Y, Tissot C, Fraga MV, Yousef N, Cortes RG, Lopez J, Sanchez-de-Toledo J, Brierley J, Colunga JM, Raffaj D, Da Cruz E, Durand P, Kenderessy P, Lang HJ, Nishisaki A, Kneyber MC, Tissieres P, Conlon TW, De Luca D. International evidence-based guidelines on Point of Care Ultrasound (POCUS) for critically ill neonates and children issued by the POCUS Working Group of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC). Crit Care. 2020 Feb 24;24(1):65. doi: 10.1186/s13054-020-2787-9.

    PubMed 32093763
  • Guo BB, Pang L, Yang B, Zhang C, Chen XY, OuYang JB, Wu CJ. Lung Ultrasound for the Diagnosis and Management of Neonatal Respiratory Distress Syndrome: A Minireview. Front Pediatr. 2022 Apr 14;10:864911. doi: 10.3389/fped.2022.864911. eCollection 2022.

    PubMed 35498779
  • Fortas F, Loi B, Centorrino R, Regiroli G, Ben-Ammar R, Shankar-Aguilera S, Yousef N, De Luca D. Enhanced INSURE (ENSURE): an updated and standardised reference for surfactant administration. Eur J Pediatr. 2022 Mar;181(3):1269-1275. doi: 10.1007/s00431-021-04301-x. Epub 2021 Nov 4.

    PubMed 34735625
  • Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.

    PubMed 26237465
  • Pareek P, Deshpande S, Suryawanshi P, Sah LK, Chetan C, Maheshwari R, More K. Less Invasive Surfactant Administration (LISA) vs. Intubation Surfactant Extubation (InSurE) in Preterm Infants with Respiratory Distress Syndrome: A Pilot Randomized Controlled Trial. J Trop Pediatr. 2021 Aug 27;67(4):fmab086. doi: 10.1093/tropej/fmab086.

    PubMed 34595526

Questions about this trial

What is this clinical trial studying?

A study testing Evaluation of serial lung ultrasound data after ENSURE surfactant treatments and Evaluation of serial lung ultrasound data after LISA surfactant treatments in people with Newborn Complication and Respiratory Distress Syndrome, Newborn, run by Konya 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MELEK BUYUKEREN (+903323105000, melekbuyukeren@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of serial lung ultrasound data after surfactant treatments (time frame: 6 hours after completion of surfactant administration). 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 NCT06880016, which also lists 8 linked publications.

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 9 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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