ClinicalTrials.gg
RecruitingNCT06880016Updated Jul 9, 2026

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

An interventional study of Evaluation of serial lung ultrasound data after ENSURE surfactant treatments and Evaluation of serial lung ultrasound data after LISA surfactant treatments in Newborn Complication and Respiratory Distress Syndrome, Newborn, sponsored by Konya City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 1 Day to 5 Days. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Konya City Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2024, registered Mar 2025).
  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Non-randomized
Ages
1 Day to 5 Days
Sex
All
01

Study 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 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.

02

Conditions studied

  • Newborn Complication
  • Respiratory Distress Syndrome, Newborn

Keywords

  • NEWBORN
  • Respiratory Distress Syndrome
  • surfactant
03

In context

Respiratory Distress Syndrome, Newborn

123 studies on the registry are indexed under Respiratory Distress Syndrome, Newborn; 24 are open to participants now.

This study's planned enrollment of 68 is below the median of 90 across 93 interventional studies indexed under Respiratory Distress Syndrome, Newborn.

Browse Respiratory Distress Syndrome, Newborn studies →

Lead sponsor

Konya City Hospital is the lead sponsor of 81 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 5 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Infants whose families did not provide consent
  • Infants with a syndromic appearance or congenital heart disease
  • Preterm infants born after 32 weeks of gestation
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Ensure group

    The first method involves intubating the infant, administering intratracheal surfactant, and then extubating them back to nasal respiratory support (ENSURE method).

    Diagnostic Test: Evaluation of serial lung ultrasound data after ENSURE surfactant treatments

  • Experimental
    Lisa group

    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).

    Diagnostic Test: Evaluation of serial lung ultrasound data after LISA surfactant treatments

Interventions

  • Diagnostic testEvaluation of serial lung ultrasound data after ENSURE surfactant treatments

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

  • Diagnostic testEvaluation of serial lung ultrasound data after LISA surfactant treatments

    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)

06

What researchers measure

Primary outcomes

  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.

    Time frame: 6 hours after completion of surfactant administration

07

Study locations

1 of 1 sites recruiting
  • Melek Buyukeren
    Konya, Karatay 42020, Turkey (Türkiye)
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No — Once the study is published as a scientific article, it can be shared.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06880016
Lead sponsor
Konya City Hospital
Responsible party
Melek Buyukeren (Associate Professor, Konya City Hospital) — Principal investigator
First posted
Mar 17, 2025
Start date
Jul 1, 2024
Primary completion
Jan 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Jul 9, 2026

Study contacts

MELEK BUYUKEREN
Contact
melekbuyukeren@gmail.com
+903323105000
MELEK BUYUKEREN
principal investigator · Konya City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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