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NCT05615428: FAST2
Fast Assessment of Surfactant Deficiency in Preterm Infants to Speed up Treatment - Validation Study
trial testing LS-ratio in Surfactant Deficiency Syndrome Neonatal in 68 participants. Completed in 1 August 2023.
1 August 2023
Quick facts
| Lead sponsor | Rigshospitalet, Denmark |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 68 |
| Start date | 16 February 2023 |
| Primary completion | 1 August 2023 |
| Estimated completion | 1 August 2023 |
| Sites | 3 locations across Denmark |
Drugs / interventions tested
- LS-ratio
Conditions studied
- Surfactant Deficiency Syndrome Neonatal — all drugs for Surfactant Deficiency Syndrome Neonatal →
- Respiratory Distress Syndrome in Premature Infant — all drugs for Respiratory Distress Syndrome in Premature Infant →
Sponsor
Rigshospitalet, Denmark
Who can join
Under 45 Minutes, any sex, with Surfactant Deficiency Syndrome Neonatal or Respiratory Distress Syndrome in Premature Infant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Predicting Surfactant Need at Birth: Failed Validation of a Bedside Method Using Gastric Aspirates.
Heiring C, Poorisrisak P, Breindahl N, Zachariassen G, et al · · 2025 · PMID 40346998 · DOI 10.1111/apa.70128
Verify or expand the search:
- PubMed search for NCT05615428
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of LS-ratio
Trials testing the same drug.
- NCT03235882 — Fast Assessment of Surfactant Deficiency to Speed up Treatment · completed
Other recruiting trials for Surfactant Deficiency Syndrome Neonatal
Currently open trials in the same condition.
- NCT06554522 — Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa · Phase 4 · recruiting
- NCT04445571 — Surfactant Administration by Insure or Thin Catheter · NA · recruiting
- NCT03735563 — Premedication for Less Invasive Surfactant Administration · Phase 4 · recruiting
Other Rigshospitalet, Denmark trials
Trials by the same sponsor.
- NCT07401368 — Clinicians' Trust in AI-Based Fetal Growth Estimates · NA · not yet recruiting
- NCT07442357 — The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial · NA · not yet recruiting
- NCT07528729 — Alcohol as a Modifiable Risk Factor for Atrial Fibrillation · NA · not yet recruiting
- NCT07511439 — Reversible Effects of Oral Contraceptive Removal on Serotonergic Neurotransmission · Phase 4 · not yet recruiting
- NCT07467187 — Invasive Home Ventilation in Denmark · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05615428 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rigshospitalet, Denmark
- Last refreshed: 7 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05615428.
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