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Lung UltrasouNd Guided Surfactant Therapy in Preterm Infants (LUNG Study)

NCT05198375 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2025-05-29

No results posted yet for this study

Summary

The investigators hypothesized that the use of lung ultrasound (LU) for measuring RDS severity and deciding surfactant treatment thresholds might decrease the incidence of early and late sequelae in the study group. Thus, a timely surfactant therapy would eventually improve short (e.g. Need of mechanical ventilation in the first 3 days) and more long-term outcomes, such as BPD or death.

To confirm this hypothesis, the investigators planned an international multicenter randomized controlled study in which preterm infants will be randomized into two groups: one will be managed deciding surfactant treatment of preterm infants with RDS on the basis of a cut-off value of FiO2 as for European guidelines, and one will be managed deciding surfactant treatment using a LU score cut-off and/or FiO2.

Primary endpoint will be the reduction in proportion of infants with BPD or death in the group managed with LU compared to the control group

Conditions

  • Respiratory Distress Syndrome, Newborn

Interventions

DIAGNOSTIC_TEST

Lung ultrasound score (LUS)

LU score (LUS) will be performed between 1 and 3 hours of life. LUS will be calculated by performing longitudinal scans of the chest in the anterior (midclavicular line), lateral (anterior axillary line) and posterior (posterior axillary line) area bilaterally using high-frequency linear or micro linear (hockey stick) probe. A score from 0 to 3 will be assigned to each area based on the ultrasound detected pattern.

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Principal Investigators

  • Iuri Corsini, MD · Careggi University Hospital of Florence

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
3 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-05
Primary Completion
2025-05-23
Completion
2025-05-23

Countries

  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05198375 on ClinicalTrials.gov