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Not Yet Recruiting NCT05615428

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

Conditions: Surfactant Deficiency Syndrome Neonatal, Respiratory Distress Syndrome in Premature Infant

Sex: All
Ages: N/A – 45 Minutes
Enrollment: 70
Sponsor: Rigshospitalet, Denmark

Location: Denmark

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)

Eligibility Criteria

Inclusion Criteria:GA ≤29+6, inborn at a participating centre Age less than 45 minutes as gastric aspirate must be sampled within 45 minutes from delivery.Exclusion criteria:Treated with surfactant beforerandomisation and obtaining gastric aspiratesDiagnosis of major malformations (major congenital heart defects, congenital diaphragmatic hernia, gastroschisis/omphalocele, pulmonary abnormalities including pulmonary hypoplasia and trachea-oesophageal fistulaAntenatal suspicion of significant oligohydramnios and lung hypoplasiaAny intrauterine intervention except if done for genetic testing

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05615428). StuddyBuddy aggregates publicly available trial information.