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

NCT05615428 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2025-05-07

No results posted yet for this study

Summary

The aim is to re-validate a FTIR spectroscopy test for measuring lung maturity/Respiratory Distress Syndrome (RDS) before conducting a RCT using this test to guide surfactant treatment of preterm infants.

The test has been validated previously (NCT03235882) but needs re-validation due to continued improvement in accuracy and since the test is now developed into a Point of Care test (POC-test).

The purpose is to accurately predict RDS using Lecithin/Sphingomyelin ratio (L/S ratio determined by a rapid FTIR in a newly developed point of care test (POC-test) on fresh gastric aspirates using retrospective analysis.

The FAST 2 Validation Study is a part of the FAST 2 Trial consisting of a validation study and a subsequent randomized clinical trial, that will be registered separately on clinicaltrials.gov (NTC XXXXXXXXX)

Conditions

  • Surfactant Deficiency Syndrome Neonatal
  • Respiratory Distress Syndrome in Premature Infant

Interventions

DIAGNOSTIC_TEST

LS-ratio

Included infants will have a gastric aspirate sampled via an NG tube at birth. This sample will be analyzed to determine the LS-ratio The LS-ratio will retrospectively be compared to RDS development and need for surfactant treatment to establish the cut-off ratio for LS-ratio with respect to surfactant treatment.

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

Eligibility

Max Age
45 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-16
Primary Completion
2023-08-01
Completion
2023-08-01

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 NCT05615428 on ClinicalTrials.gov