Surfactant Deficiency Syndrome NeonatalFAST2NCT05638568
Fast Assessment of Surfactant Deficiency in Preterm Infants to Speed up Treatment
A study testing LS test in people with Surfactant Deficiency Syndrome Neonatal and Respiratory Distress Syndrome, Newborn, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages Up to 45 minutes
- Conditions the study is for
- Surfactant Deficiency Syndrome Neonatal, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
- What is being tested?
- LS test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Jul 2024to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- GA ≤ 29+6, inborn at a participating centre
- Age less than 45 minutes as GAS must be sampled within 45 minutes from delivery.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aalborg University Hospital
Aalborg, 9000
Aarhus Universtity Hospital
Aarhus, 8200
Department of Neonatology, Rigshospitalet
Copenhagen, 2100
Odense University Hospital
Odense
About this study
Official title: FAST TRIAL 2 - Fourier-transform Infrared Spectroscopy(FTIR) Guided Surfactant Therapy - RCT
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.
Read the 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).
- Conditions
- Surfactant Deficiency Syndrome Neonatal, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
- Being tested
- LS test
- Keywords
- surfactant assay, surfactant replacement therapy
- Medical subject headings
- Pulmonary Atelectasis, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LS testDiagnostic test
If the LS test indicated surfactant deficiency based on the cut off ratio early surfactant treatment will be done for patients in the intervention group If the LS test indicated no surfactant deficiency routine surfactant treatment will be done as per European RDS guidelines based on oxygen requirement (FiO2 > 0.30)
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm LS guided treatment | Experimental | all participating infants will have a gastric aspirate (GAS) sampled at birth within 45 minutes of life.
The GAS will be analyzed immediately at the bedside by a LS-test POC device. For infants allocated to the interventional group the LS-result will be displayed as "treat with surfactant" or " do not treat with surfactant" depending on wether the LS-ratio is under or above the cut-off ratio for treatment.
Those with LS-ratio above the cut-off ratio will be treated with surfactant as per routine in accordance with the European RDS guidelines based on oxygen requirement (FiO2 > 0.30) - ie same as in control group. Receives: Diagnostic Test: LS test |
| Control arm - routine surfactant treatment | No intervention | all participating infants will have a gastric aspirate (GAS) sampled at birth within 45 minutes of life. The GAS will be analyzed immediately at the bedside by a LS-test POC device, but result will remain blinded. Infants allocated to the control group will be treated with surfactant as per routine in accordance with the European RDS guidelines based on oxygen requirement (FiO2 > 0.30). The LS-ratio for those infants will remain blinded |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without moderate to severe bronchopulmonary dysplasia (BPD)
BPD is defined as per a modified "NIH definition" in which any degree of respiratory support for at least 28 days is considered equal to the need for oxygen:
- Treatment with oxygen > 21% or any degree of respiratory support for a least 28 days plus
- Need for treatment with oxygen > 21% or any degree of respiratory support at PMA 36 weeks or at discharge, whichever comes first.
Definitions:
- Moderate BPD is defined as treatment with oxygen > 21% or any degree of respiratory support for a least 28 days plus need of supplemental oxygen from >21% to < 30% (as low flow O2) at 36+0 weeks PMA
- Severe BPD is defined as treatment with oxygen > 21% or any degree of respiratory support for a least 28 days plus need of > 30% oxygen and/or continuous need for any level of respiratory support providing positive airway pressure (nHFT, nCPAP, NIV or mechanical ventilation)
Measured: at 36 weeks PMA or discharge withever comes first
Secondary outcomes (13)
mortality
assessed at discharged
Measured: From date of birth until the date of death if this happens before discharge
Bronchopulmonary dysplasia
BPD is defined as per a modified "NIH definition" in which any degree of respiratory support for at least 28 days is considered equal to the need for oxygen:
- Treatment with oxygen > 21% or any degree of respiratory support for a least 28 days plus
- Need for treatment with oxygen > 21% or any degree of respiratory support at PMA 36 weeks or at discharge, whichever comes first.
Definitions:
- Moderate BPD is defined as treatment with oxygen > 21% or any degree of respiratory support for a least 28 days plus need of supplemental oxygen from >21% to < 30% (as low flow O2) at 36+0 weeks PMA
- Severe BPD is defined as treatment with oxygen > 21% or any degree of respiratory support for a least 28 days plus need of > 30% oxygen and/or continuous need for any level of respiratory support providing positive airway pressure (nHFT, nCPAP, NIV or mechanical ventilation)
Measured: at 36 weeks PMA or discharge withever comes first
LS-ratio
POC measurement using FTIR Spectroscopy
Measured: 72 hours
Nectrotizing enterocolitis
According to Bell classification/AXR
Measured: From date of birth to 44 weeks of gestational age (usually around 18 weeks)
Spontaneous intestinal perforation
As diagnosed on AXR
Measured: From date of birth to 44 weeks of gestational age (usually around 18 weeks)
Intraventricular hemorhage
According to Papile classification
Measured: From date of birth to 44 weeks of gestational age (usually around 18 weeks)
Airleak
Assessed on CXR or lung ultrasound
Measured: From date of birth to 44 weeks of gestational age (usually around 18 weeks)
surfactant treatment,
from medical record
Measured: 72 hours
surfactant treatmentdose,
from medical record
Measured: 72 hours
number of surfactant treatments,
from medical record
Measured: 72 hours
timing surfactant treatments,
from medical record
Measured: 72 hours
gastric aspirate obtained
from medical record
Measured: 72 hours
gastric aspirate analyzed
from medical record
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Why it stopped: Concerns about the validity of the method
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surfactant Deficiency Syndrome NeonatalStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- all participating infants will have a gastric aspirate (GAS) sampled at birth within 45 minutes of life. The GAS will be analyzed bedside by a LS-test POC device. For infants allocated to the interventional group the LS-result will be displayed as "treat with surfactant" or " do not treat with surfactant" depending on wether the LS-ratio is under or above the cut-off ratio for treatment. Those with LS-ratio above the cut-off ratio will be treated with surfactant as per routine in accordance with the European RDS guidelines based on oxygen requirement (FiO2 \> 0.30) Infants allocated to the control group will be treated with surfactant as per routine in accordance with the European RDS guidelines based on oxygen requirement (FiO2 \> 0.30). The LS-ratio for those infants will remain blinded
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Aalborg University Hospital, Aarhus University Hospital, Holbaek Sygehus
- Responsible party
- Principal investigator, Christian Heiring, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian Heiring, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638568
- Sponsor's protocol ID
- H-22007105 RCT Study
- Acronym
- FAST2
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2022
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAST TRIAL 2 - Fourier-transform Infrared Spectroscopy(FTIR) Guided Surfactant Therapy - RCT
- ClinicalTrials.gov ID
- NCT05638568
- Acronym / sponsor ID
- FAST2 / H-22007105 RCT Study
- Conditions
- Surfactant Deficiency Syndrome Neonatal, Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
- Keywords
- surfactant assay, surfactant replacement therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Concerns about the validity of the method
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Odense University Hospital, Aalborg University Hospital, Aarhus University Hospital, Holbaek Sygehus
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- all participating infants will have a gastric aspirate (GAS) sampled at birth within 45 minutes of life. The GAS will be analyzed bedside by a LS-test POC device. For infants allocated to the interventional group the LS-result will be displayed as "treat with surfactant" or " do not treat with surfactant" depending on wether the LS-ratio is under or above the cut-off ratio for treatment. Those with LS-ratio above the cut-off ratio will be treated with surfactant as per routine in accordance with the European RDS guidelines based on oxygen requirement (FiO2 > 0.30) Infants allocated to the control group will be treated with surfactant as per routine in accordance with the European RDS guidelines based on oxygen requirement (FiO2 > 0.30). The LS-ratio for those infants will remain blinded
| Arm | Type | Receives |
|---|---|---|
| Intervention arm LS guided treatment | Experimental | Diagnostic Test: LS testall participating infants will have a gastric aspirate (GAS) sampled at birth within 45 minutes of life. The GAS will be analyzed immediately at the bedside by a LS-test POC device. For infants allocated to the interventional group the LS-result will be displayed as "treat with surfactant" or " do not treat with surfactant" depending on wether the LS-ratio is under or above the cut-off ratio for treatment. Those with LS-ratio above the cut-off ratio will be treated with surfactant as per routine in accordance with the European RDS guidelines based on oxygen requirement (FiO2 > 0.30) - ie same as in control group. |
| Control arm - routine surfactant treatment | No intervention | –all participating infants will have a gastric aspirate (GAS) sampled at birth within 45 minutes of life. The GAS will be analyzed immediately at the bedside by a LS-test POC device, but result will remain blinded. Infants allocated to the control group will be treated with surfactant as per routine in accordance with the European RDS guidelines based on oxygen requirement (FiO2 > 0.30). The LS-ratio for those infants will remain blinded |
Who may qualify
- Ages
- Up to 45 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- GA ≤ 29+6, inborn at a participating centre
- Age less than 45 minutes as GAS must be sampled within 45 minutes from delivery.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LS testIf the LS test indicated surfactant deficiency based on the cut off ratio early surfactant treatment will be done for patients in the intervention group If the LS test indicated no surfactant deficiency routine surfactant treatment will be done as per European RDS guidelines based on oxygen requirement (FiO2 > 0.30) | Diagnostic test | Intervention arm LS guided treatment |
Primary outcome
Survival without moderate to severe bronchopulmonary dysplasia (BPD)
Time frame: at 36 weeks PMA or discharge withever comes first
BPD is defined as per a modified "NIH definition" in which any degree of respiratory support for at least 28 days is considered equal to the need for oxygen: * Treatment with oxygen > 21% or any degree of respiratory support for a least 28 days plus * Need for treatment with oxygen > 21% or any degree of respiratory support at PMA 36 weeks or at discharge, whichever comes first. Definitions: * Moderate BPD is defined as treatment with oxygen > 21% or any degree of respiratory support for a least 28 days plus need of supplemental oxygen from >21% to < 30% (as low flow O2) at 36+0 weeks PMA * Severe BPD is defined as treatment with oxygen > 21% or any degree of respiratory support for a least 28 days plus need of > 30% oxygen and/or continuous need for any level of respiratory support providing positive airway pressure (nHFT, nCPAP, NIV or mechanical ventilation)
13 secondary outcomes
mortality
Time frame: From date of birth until the date of death if this happens before discharge
Bronchopulmonary dysplasia
Time frame: at 36 weeks PMA or discharge withever comes first
LS-ratio
Time frame: 72 hours
Nectrotizing enterocolitis
Time frame: From date of birth to 44 weeks of gestational age (usually around 18 weeks)
Spontaneous intestinal perforation
Time frame: From date of birth to 44 weeks of gestational age (usually around 18 weeks)
Intraventricular hemorhage
Time frame: From date of birth to 44 weeks of gestational age (usually around 18 weeks)
Airleak
Time frame: From date of birth to 44 weeks of gestational age (usually around 18 weeks)
surfactant treatment,
Time frame: 72 hours
surfactant treatmentdose,
Time frame: 72 hours
number of surfactant treatments,
Time frame: 72 hours
timing surfactant treatments,
Time frame: 72 hours
gastric aspirate obtained
Time frame: 72 hours
gastric aspirate analyzed
Time frame: 72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Heiring principal investigator
Copenhagen University Hospital, Rigshospitalet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LS test in people with Surfactant Deficiency Syndrome Neonatal and Respiratory Distress Syndrome, Newborn, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without moderate to severe bronchopulmonary dysplasia (BPD) (time frame: at 36 weeks PMA or discharge withever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.