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Clinical Trials/NCT06880016
NCT06880016RecruitingNot Applicable

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

Konya City Hospital1 site in 1 country68 target enrollmentStarted: July 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
68
Locations
1
Primary Endpoint
Evaluation of serial lung ultrasound data after surfactant treatments

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
1 Day to 5 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

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

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

Arms & Interventions

Ensure group

Experimental

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

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

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).

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

Outcomes

Primary Outcomes

Evaluation of serial lung ultrasound data after surfactant treatments

Time Frame: 6 hours after completion of surfactant administration

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Konya City Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Melek Buyukeren

Associate Professor

Konya City Hospital

Study Sites (1)

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