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Fast Assessment of Surfactant Deficiency to Speed up Treatment

NCT03235882 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2020-03-16

No results posted yet for this study

Summary

The aim is to validate a FTIR spectroscopy test for measuring lung maturity/Respiratory Distress Syndrome (RDS) in terms of safety, usability, and efficacy.

The purpose is to accurately predict RDS using Lecithin/Sphingomyelin ratio (L/S ratio determined by a rapid FTIR test on fresh gastric aspirates) using retrospective analysis.

Research question:

"In very preterm newborn infants with (risk of) respiratory distress who have not received prophylactic surfactant: does analysis of L/S-ratio in fresh gastric aspirates using a rapid FTIR test predict RDS requiring exogenous surfactant with sufficient specificity and sensitivity to be clinical useful?

Conditions

  • RDS of Prematurity
  • Prematurity

Interventions

DIAGNOSTIC_TEST

LS-ratio

Accurately predict RDS using Lecithin/Sphingomyelin ratio (L/S ratio determined by a rapid FTIR test on fresh gastric aspirates) using retrospective analysis

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Kolding Sygehus

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Herlev Hospital

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Holbaek Sygehus

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Eligibility

Max Age
45 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-04-26
Completion
2019-04-26

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 NCT03235882 on ClinicalTrials.gov