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

NCT06880016 | Recruiting

• 1 other identifier: KSH_MB_2025_3
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Distress Syndrome, Newborn; Newborn Complication

Keywords

NEWBORN; Respiratory Distress Syndrome; surfactant

Outcome Measures

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.

  6 hours after completion of surfactant administration

Study Arms (2)

Ensure group

EXPERIMENTAL

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

Lisa group

EXPERIMENTAL

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

Evaluation of serial lung ultrasound data after LISA surfactant treatments DIAGNOSTIC_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)

Lisa group

Evaluation of serial lung ultrasound data after ENSURE surfactant treatments DIAGNOSTIC_TEST

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

Ensure group

Eligibility Criteria

• Age: 1 Day - 5 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Melek Buyukeren

Konya, Karatay, 42020, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• 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.

  PMID: 2191263 BACKGROUND

• 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.

  PMID: 30304736 BACKGROUND

• 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.

  PMID: 35558371 BACKGROUND

• 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.

  PMID: 32093763 BACKGROUND

• 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.

  PMID: 35498779 BACKGROUND

• 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.

  PMID: 34735625 BACKGROUND

• 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.

  PMID: 26237465 BACKGROUND

• 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.

  PMID: 34595526 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• MELEK BUYUKEREN

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MELEK BUYUKEREN

CONTACT

+903323105000; melekbuyukeren@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: July 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)