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NCT05638568
Fast Assessment of Surfactant Deficiency in Preterm Infants to Speed up Treatment
Conditions: Surfactant Deficiency Syndrome Neonatal, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
Sex: All
Ages: N/A – 45 Minutes
Phase: NA
Enrollment: 380
Sponsor: Rigshospitalet, Denmark
Location: Denmark
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.
Eligibility Criteria
Inclusion Criteria:GA ≤ 29+6, inborn at a participating centreAge less than 45 minutes as GAS must be sampled within 45 minutes from delivery.Exclusion Criteria:Treated with surfactant before randomisation 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
Source: ClinicalTrials.gov (NCT05638568). StuddyBuddy aggregates publicly available trial information.