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Fast Assessment of Surfactant Deficiency in Preterm Infants to Speed up Treatment

NCT05638568 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-05-07

No results posted yet for this study

Summary

Recently the investigators have developed a point of care test (LS-test) to measure surfactant as lecithin in gastric aspirates from preterm infants.

This test can be done immediately at delivery and potentially be used to guide surfactant treatment.

To obtain evidence-based knowledge on harms and benefit of surfactant therapy guided by the L/S test, a randomized clinical trial with relevant clinical short-and long-term outcomes needs to be performed, which is why the FAST 2 Trial has been designed.

Conditions

  • Surfactant Deficiency Syndrome Neonatal
  • Respiratory Distress Syndrome, Newborn
  • Bronchopulmonary Dysplasia

Interventions

DIAGNOSTIC_TEST

LS test

If the LS test indicated surfactant deficiency based on the cut off ratio early surfactant treatment will be done for patients in the intervention group If the LS test indicated no surfactant deficiency routine surfactant treatment will be done as per European RDS guidelines based on oxygen requirement (FiO2 \> 0.30)

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Holbaek Sygehus

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Christian Heiring · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
45 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2028-07-01
Completion
2029-01-01

Countries

  • Denmark

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 NCT05638568 on ClinicalTrials.gov