Respiratory Distress Syndrome in Premature Infant Clinical Trial
— FAST2Official title:
FAST TRIAL 2 -Fourier-transform Infrared Spectroscopy(FTIR)Guided Surfactant Therapy - Validation Study
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)
Status | Recruiting |
Enrollment | 70 |
Est. completion date | November 1, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 45 Minutes |
Eligibility | Inclusion Criteria: GA =29+6, inborn at a participating centre Age less than 45 minutes as gastric aspirate must be sampled within 45 minutes from delivery. Exclusion criteria: Treated with surfactant beforerandomisation 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University Hospital | Aalborg | |
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Aalborg University Hospital, Aarhus University Hospital, Holbaek Sygehus, Odense University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LS-ratio cut-off | The primary objective is to measure the L/S-ratio in fresh GAS using the AIMI 1.0/2.0 L/S POC Device and compare the L/S-ratio with the need for surfactant treatment aiming to validate the previously defined cut-off L/S-ratio for surfactant treatment and to determine if the cut-off L/S ratio needs adjustment before starting FAST 2 RCT | 5 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04016246 -
Respiratory Effect of the LISA Method With Sedation by Propofol Versus Absence of Sedation.
|
Phase 3 | |
Enrolling by invitation |
NCT04118400 -
Ventilator Weaning Outcome Between NIV-NAVA and Nasal CPAP (or IMV ) Modes in Premature Neonates
|
||
Completed |
NCT01941745 -
Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome
|
Phase 2 | |
Not yet recruiting |
NCT04019106 -
Budesonide With Intratracheal Surfactants in Extremely Preterm Infants
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04862377 -
Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.
|
Phase 3 | |
Not yet recruiting |
NCT05791331 -
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
|
N/A | |
Completed |
NCT04086095 -
Feasibility Study - Neofact
|
N/A | |
Not yet recruiting |
NCT05609877 -
The NONA-LISA Trial
|
N/A | |
Recruiting |
NCT04326270 -
Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs
|
N/A | |
Active, not recruiting |
NCT03969992 -
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
|
Phase 2 | |
Completed |
NCT03700606 -
Physiological Changes With High-Flow Nasal Cannula
|
N/A | |
Recruiting |
NCT04359134 -
Combined Lung Ultrasounds and Transthoracic Electrical Bioimpedance in Preterm Infants With Respiratory Distress.
|
||
Not yet recruiting |
NCT06229821 -
Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants
|
N/A | |
Recruiting |
NCT05446389 -
PAL to Improve Oral Feeding for Infants With Chronic Lung Disease
|
N/A | |
Withdrawn |
NCT04914715 -
nHFOV Versus Invasive Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome
|
N/A | |
Recruiting |
NCT03825835 -
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
|
N/A | |
Recruiting |
NCT03562182 -
Effect of Steroid Administration on Maternal Blood Levels of hLPCAT1 mRNA
|
||
Completed |
NCT05031650 -
Open Lung Strategy During Non-Invasive Respiratory Support of Very Preterm Infants in the Delivery Room
|
N/A | |
Completed |
NCT03306524 -
The Role of Circuit Flow During Mechanical Ventilation of Neonates
|
N/A | |
Completed |
NCT01473264 -
Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)
|
Phase 1/Phase 2 |