WithdrawnNot Applicable

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

Stopped: Concerns about the validity of the method

Denmark0Started 2024-07-01

Plain-language 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.

Who can participate

Age range45 Minutes

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Survival without moderate to severe bronchopulmonary dysplasia (BPD)

Timeframe: at 36 weeks PMA or discharge withever comes first

Trial details

NCT IDNCT05638568

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-01

View on ClinicalTrials.gov More Surfactant Deficiency Syndrome Neonatal trials