Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Treatment of respiratory distress syndrome (RDS) has evolved greatly over the past three decades. Major advances in treatment include antenatal steroids, early nasal continuous positive airway pressure (nCPAP) combined with early rescue surfactant replacement strategies such as Intubation Surfactant Extubation (INSURE) and Less Invasive Surfactant Administration (LISA), together with use of lung protective ventilation and overall reduced use of mechanical ventilation. However, RDS and bronchopulmonary dysplasia (BPD) are still major causes of mortality and morbidity in premature infants. To improve the outcome, very early treatment with surfactant is necessary. However, only about half of infants with a gestational age (GA) below 30 weeks need surfactant treatment and prophylactic surfactant treatment increases the combined mortality and incidence of BPD contrary to selective rescue surfactant treatment. Therefore, there is a need for a rapid test to guide early targeted surfactant treatment. The investigators have recently developed a new test of lung maturity based on measuring the lecithin sphingomyelin ratio (L/S) in fresh gastric aspirates (GAS) from newborn preterm infants using mid-red Fourier Transform Infrared spectroscopy (FTIR). The sphingomyelin concentration in amniotic fluid and accordingly in GAS is relatively constant during the pregnancy, whereas the lecithin (or dipalmitoylphosphatidylcholine (DPPC), the lung surfactant phospholipid with the highest surface activity) concentration increases with the lung maturation. It has been demonstrated in clinical observational trials that this laboratory based L/S-test predicts development of RDS when measured immediately at delivery (FAST 1 Trial). The L/S-test has now been developed into an easy-to-use Point of Care (POC) test for bedside use that expresses the L/S ratio in approximately 10 minutes. It is believed this new POC test can be used to guide surfactant therapy, enabling very early rescue treatment, potentially even before symptoms occur. 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. During design and development of the FAST 2 Trial protocol extensive engineering work has been conducted towards building a fully automated L/S POC Device (AIMI 1.0/2.0) from the prototypes in the first L/S studies (including FAST 1 Trial). During this process the accuracy of the L/S algorithm has been improved through machine learning and use of artificial intelligence. Consequently, the previously defined cut-off ratio from the FAST 1 Trial needs to be re-validated using the L/S POC Device in a new population of preterm infants. The FAST 2 Trial therefore consists of two individual studies starting with the FAST 2 Validation Study which will followed by the FAST 2 Randomized Clinical Trial (FAST 2 RCT) once completed. The FAST 2 Validation study has been registered separately on clinicaltrials.gov (NCT05615428). This registration concerns the FAST 2 RCT Participants: Preterm newborn infants with gestational age at birth of ≤ 29+6 weeks who have not received prophylactic surfactant. Intervention: Surfactant treatment guided by fast determination of the L/S-ratio in a fresh gastric aspirate (GAS) obtained at birth, measured by Fourier Transform Mid-infrared Spectroscopy as a POC test. Comparison: Standard rescue surfactant treatment based on clinical criteria defined by the European Consensus Guidelines on the management of Respiratory Distress Syndrome Outcome: Infants surviving without moderate to severe BPD assessed at 36 weeks post menstrual age as per a modified NIH definition The primary outcome is a composite of survival without moderate to severe BPD, defined as per a modified "NIH definition" The primary objective is to compare the rate of survival without moderate to severe BPD between 2 groups: - L/S guided treatment of surfactant deficiency with exogenous surfactant (intervention group) vs. - Standard treatment of surfactant deficiency (comparison). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05638568
Study type Interventional
Source Rigshospitalet, Denmark
Contact Christian Heiring
Phone +4535453545
Email christian.heiring@regionh.dk
Status Not yet recruiting
Phase N/A
Start date July 1, 2024
Completion date January 1, 2029

See also
  Status Clinical Trial Phase
Terminated NCT04506619 - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed NCT04936477 - Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants N/A
Recruiting NCT05285345 - Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Terminated NCT02524249 - Early Versus Late Caffeine for ELBW Newborns N/A
Completed NCT02249143 - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants N/A
Active, not recruiting NCT01632475 - Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Completed NCT00419588 - Growth of Airways and Lung Tissues in Premature and Healthy Infants
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Completed NCT00208039 - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates N/A
Completed NCT00319956 - Trial II of Lung Protection With Azithromycin in the Preterm Infant Phase 2
Completed NCT00006401 - Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants Phase 3
Terminated NCT05030012 - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants N/A
Completed NCT00006058 - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns N/A
Completed NCT00005376 - Premature Birth and Its Sequelae in Women N/A
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Completed NCT00004805 - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death N/A
Completed NCT05152316 - The Baby Lung Study
Recruiting NCT04821453 - NAVA vs. CMV Crossover in Severe BPD N/A