Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-27 @ 9:55 PM
Study NCT ID:
NCT05638568
Status:
WITHDRAWN
Last Update Posted:
2025-05-07
First Post:
2022-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fast Assessment of Surfactant Deficiency in Preterm Infants to Speed up Treatment
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
FAST TRIAL 2 - Fourier-transform Infrared Spectroscopy(FTIR) Guided Surfactant Therapy - RCT
Status:
WITHDRAWN
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Concerns about the validity of the method
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAST2
Brief 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.
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.
Detailed 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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: