Respiratory Distress SyndromeNCT06421506
Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants
A study testing Less invasive surfactant administration during high flow nasal cannula treatment in people with Respiratory Distress Syndrome and Preterm Pregnancy, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6 weeks early. Read more about this study
- Who is it for?
- Ages 34 to 38 weeks
- Conditions the study is for
- Respiratory Distress Syndrome, Preterm Pregnancy, Surfactant Deficiency Syndrome Neonatal
- What is being tested?
- Less invasive surfactant administration during high flow nasal cannula treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 May 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 34 to 38 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born at 34+0 to 38+6 weeks of gestation, requiring resuscitation at birth, but who achieve regular spontaneous breathing and have a heart rate over 100 beats per minute while receiving non-invasive support.
- Infants enrolled in the Surfon trial, born at 34+0 to 38+6 weeks of gestation, who are less than or equal to 24 hours old and exhibit signs of respiratory distress, defined as an FiO2 greater or equal to 0.30 but less than 0.45 needed to maintain an SpO2 greater than or equal to 92% or a clinically significant work of breathing regardless of the FiO2 and a clinical decision to provide non-invasive respiratory support.
Who cannot join
- Infants requiring intubation at birth
- Infants with severe congenital anomalies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London
Eleanor Jeffreys, MBBS, 07519974813, eleanor.jeffreys@nhs.net
About this study
Official title: Does Less Invasive Surfactant Administration (LISA) During High-flow Nasal Cannula Oxygen Treatment Reduces the Need for Invasive Ventilation in Late Preterm and Term Born Infants With Respiratory Distress?
The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6 weeks early.
Less invasive surfactant administration is where surfactant (a naturally produced substance which helps open up the tiny air sacs in the lungs making it easier for babies to breathe) is given into the lungs by putting a small tube into the windpipe through the mouth whilst the baby is awake. The surfactant is given slowly and breathed in.
Read more
High flow nasal cannula is a form of non-invasive support where a machine delivers warmed, moist oxygen and air through short tubes in the nose.
The investigators will be assessing whether a lower percentage of neonates need invasive ventilation within 72 hrs from birth when they have had LISA during HFNC treatment, compared to when they don't receive this treatment.
The investigators will also be looking at the length of neonatal unit stay and the cost of the stay. The investigators will also be measuring the lung function of the babies before and after they receive LISA.
Read the detailed description
This study is looking at babies born 2- 6 weeks early who have breathing problems soon after birth. Some babies need to go onto a breathing machine (ventilator) or require 'non-invasive' breathing support. Either a machine delivers warmed, moist oxygen + air through short tubes in the nose (humidified high flow nasal cannula, HHFNC) or a machine delivers oxygen and air via a small mask which fits over the nose (continuous positive airway pressure, CPAP). Mechanical ventilation via a ventilator, although life-saving, can cause problems such as infection and lung injury and, therefore, whenever possible baby's breathing is supported with 'non-invasive' methods. The use of CPAP in more mature babies may also cause discomfort or lung collapse, whereas use of HHFNC may avoid those problems. The lungs of healthy full-term babies naturally produce a substance called surfactant that helps open up the tiny air sacs in the lungs and makes it easier for them to breathe. Babies born early or those with problems at birth, do not have enough of their own surfactant or it does not work properly, causing difficulty in taking in oxygen. A natural, animal-derived surfactant medication can be given into the lungs, using a small tube put into the windpipe through the mouth. This is done routinely in ventilated babies born prematurely. More recently, a technique called 'Less invasive surfactant administration (LISA)' has been developed that allows us to give surfactant to babies who are receiving 'non-invasive' breathing support (ie HHFNC) and, thus, avoiding the complications related to mechanical ventilation. A small tube is passed into the windpipe whilst the baby is awake and breathing (supported on HHFNC or CPAP) and the surfactant is slowly given and breathed into the lungs. At the moment, there have been no research studies assessing the use of LISA in more mature infants receiving HHFNC as 'non-invasive' respiratory support.
In this study the investigators want to determine if in babies born between 34 and 38+6 weeks gestation who have breathing problems and receive HHFNC oxygen treatment with LISA within 24 hours of birth will reduce the need for mechanical ventilation. The investigators will also be looking a the length on neonatal unit stay, and the cost of the stay. Lung function of the babies before and after they receive LISA will be measured.
There will be no change in the management of babies taking part in the study. Use of HHFNC, administration of LISA and respiratory monitoring is all part of routine practice. The investigators are asking for consent to analyse the routine monitoring that will be undertaken before, during and after the surfactant administration and follow up on the outcome of the baby after they have had the LISA procedure.
Surfactant is routinely used in babies and there are no extra risks from taking part in this study. HHFNC is routinely used to support babies of this gestational age who require respiratory support. There are no known or expected risks from using HHFNC with LISA but as of yet there have been no studies using this combination.
Giving surfactant may help to avoid mechanical ventilation and its side effects, but this has not been studied before in these gestational ages, hence the need for this study. Theoretically giving surfactant with HHFNC should aid even distribution of surfactant throughout the lungs whilst protecting the lungs from potential damage caused by other forms of non-invasive support such as CPAP but again there is not yet evidence supporting this.
The study will be running at King's College Hospital on the Neonatal Intensive Care Unit at the Denmark hill site and at the Local Neonatal Unit at the Princess Royal Hospital site. The study has received ethical approval and is due to commence imminently (May 2024). The study is aiming to recruit 245 patients which is estimated to take 2yrs and 4 months.
The study is funded by Chiesi Limited. The chief investigator for the study is Theodore Dassios: theodore.dassios@kcl.ac.uk
- Being tested
- Less invasive surfactant administration during high flow nasal cannula treatment
- Medical subject headings
- Respiratory Distress Syndrome, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Less invasive surfactant administration during high flow nasal cannula treatmentProcedure or surgery
Surfactant distilled through a small tube inserted into the windpipe via the mouth whilst the baby is awake and supported with HFNC.
| Study group | Role | What they receive |
|---|---|---|
| Neonates given LISA during HFNC treatment | Experimental | Infants between 34-38+6 weeks gestation will receive surfactant via less invasive administration whilst on high flow nasal cannula oxygen treatment. They will have respiratory function monitoring before and after LISA. Receives: Procedure: Less invasive surfactant administration during high flow nasal cannula treatment |
| Neonates not given LISA | No intervention | Infants between 34-38+6 will receive routine care and will not receive surfactant unless intubated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of neonates needing invasive ventilation within 72 hours from birth
The percentage of babies requiring more respiratory support and therefore needing invasive ventilation within 72 hrs from birth. The percentage from the intervention group will be compared with the control group
Measured: 72 hours from birth
Secondary outcomes (8)
The length of neonatal unit stay
The duration of stay on the neonatal unit will be compared between the babies receiving the intervention, and those who are not.
Measured: The length of time the neonate is in hospital, up to 20 weeks
The cost of stay as estimated via standard NHS tariffs according to level of care
Standard NHS tariffs will be used to calculate the total cost of the stay for the babies in the intervention vs control group.
Measured: The length of time the neonate is in hospital, up to 20 weeks
The lung function parameters two minutes before and two minutes after the administration of LISA
The following lung function parameter: tidal volume will be measured for all babies receiving LISA.
Measured: The first 24 hours of life
The lung function parameters two minutes before and two minutes after the administration of LISA
The following lung function parameter: respiratory rate will be measured for all babies receiving LISA.
Measured: The first 24 hours of life
The lung function parameters two minutes before and two minutes after the administration of LISA
The following lung function parameter: fraction of inspired oxygen (FiO2) will be measured for all babies receiving LISA.
Measured: The first 24 hours of life
The lung function parameters two minutes before and two minutes after the administration of LISA
The following lung function parameter: End Tidal CO2 (ETCO2) will be measured for all babies receiving LISA.
Measured: The first 24 hours of life
The lung function parameters two minutes before and two minutes after the administration of LISA
The following lung function parameter: ratio of oxygen saturations/ fractions of inspired oxygen (SpO2/ FiO2 ratio) will be measured for all babies receiving LISA.
Measured: The first 24 hours of life
The SpO2/FiO2 ratio will be measured two hours after LISA administration
Lung function parameter: ratio SpO2/FiO2 will be measured two hours after LISA administration for all babies receiving LISA
Measured: The first 24 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start8 May 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This will be a prospective single centre study with a treatment arm and a control group.
- Masking
- None (open label)
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi Limited
- Responsible party
- Sponsor
- Investigators
- Theodore Dassios, PHD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421506
- Sponsor's protocol ID
- 324607
- Status last verified
- Aug 2026
- First submitted
- 9 May 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The General Data Protection Regulation and Data Protection Act 2018 will be adhered to. Data will be anonymised before being entered into a secure database. Each participant will be issued a unique study identifier number when enrolled and this will be used on all data collection forms. Patient paper data will be stored in a locked filing cabinet in a room that is only accessible to the research team and that is based on the Neonatal Intensive Care Unit facilities at King's College Hospital. De-identified electronic patient data will be stored on encrypted computers or memory stick devices. On completion, the data will be analysed and a final report prepared that could be accessed via the sponsor. The study will be presented at research meetings at King's College Hospital. Anonymised study data will be presented at conferences and published by the investigators in peer reviewed journals. Participants will be notified of the outcome of the study via provision of the publication.
Publications
Herting E, Hartel C, Gopel W. Less invasive surfactant administration (LISA): chances and limitations. Arch Dis Child Fetal Neonatal Ed. 2019 Nov;104(6):F655-F659. doi: 10.1136/archdischild-2018-316557. Epub 2019 Jul 11.
PubMed 31296694Shetty S, Egan H, Cornuaud P, Kulkarni A, Duffy D, Greenough A. Less Invasive Surfactant Administration in Very Prematurely Born Infants. AJP Rep. 2021 Jul;11(3):e119-e122. doi: 10.1055/s-0041-1735632. Epub 2021 Sep 22.
PubMed 34567837Smithhart W, Wyckoff MH, Kapadia V, Jaleel M, Kakkilaya V, Brown LS, Nelson DB, Brion LP. Delivery Room Continuous Positive Airway Pressure and Pneumothorax. Pediatrics. 2019 Sep;144(3):e20190756. doi: 10.1542/peds.2019-0756. Epub 2019 Aug 9.
PubMed 31399490Spence KL, Murphy D, Kilian C, McGonigle R, Kilani RA. High-flow nasal cannula as a device to provide continuous positive airway pressure in infants. J Perinatol. 2007 Dec;27(12):772-5. doi: 10.1038/sj.jp.7211828. Epub 2007 Aug 30.
PubMed 17762844Jeffreys E, Jenkinson A, Kaltsogianni O, Harris C, Bhat R, Dassios T, Greenough A. Does less invasive surfactant administration during high-flow nasal cannula oxygen treatment reduce the need for invasive ventilation in late preterm and early term born infants with respiratory distress? A study protocol for a single-centre study with a treatment and control arm. BMJ Open. 2025 Jun 23;15(6):e089399. doi: 10.1136/bmjopen-2024-089399.
PubMed 40550714
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Less Invasive Surfactant Administration (LISA) During High-flow Nasal Cannula Oxygen Treatment Reduces the Need for Invasive Ventilation in Late Preterm and Term Born Infants With Respiratory Distress?
- ClinicalTrials.gov ID
- NCT06421506
- Acronym / sponsor ID
- 324607
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Chiesi Limited
- Study start
- 8 May 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 May 2024 (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.
The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6 weeks early.
Less invasive surfactant administration is where surfactant (a naturally produced substance which helps open up the tiny air sacs in the lungs making it easier for babies to breathe) is given into the lungs by putting a small tube into the windpipe through the mouth whilst the baby is awake. The surfactant is given slowly and breathed in.
High flow nasal cannula is a form of non-invasive support where a machine delivers warmed, moist oxygen and air through short tubes in the nose.
The investigators will be assessing whether a lower percentage of neonates need invasive ventilation within 72 hrs from birth when they have had LISA during HFNC treatment, compared to when they don't receive this treatment.
The investigators will also be looking at the length of neonatal unit stay and the cost of the stay. The investigators will also be measuring the lung function of the babies before and after they receive LISA.
Detailed description
This study is looking at babies born 2- 6 weeks early who have breathing problems soon after birth. Some babies need to go onto a breathing machine (ventilator) or require 'non-invasive' breathing support. Either a machine delivers warmed, moist oxygen + air through short tubes in the nose (humidified high flow nasal cannula, HHFNC) or a machine delivers oxygen and air via a small mask which fits over the nose (continuous positive airway pressure, CPAP). Mechanical ventilation via a ventilator, although life-saving, can cause problems such as infection and lung injury and, therefore, whenever possible baby's breathing is supported with 'non-invasive' methods. The use of CPAP in more mature babies may also cause discomfort or lung collapse, whereas use of HHFNC may avoid those problems. The lungs of healthy full-term babies naturally produce a substance called surfactant that helps open up the tiny air sacs in the lungs and makes it easier for them to breathe. Babies born early or those with problems at birth, do not have enough of their own surfactant or it does not work properly, causing difficulty in taking in oxygen. A natural, animal-derived surfactant medication can be given into the lungs, using a small tube put into the windpipe through the mouth. This is done routinely in ventilated babies born prematurely. More recently, a technique called 'Less invasive surfactant administration (LISA)' has been developed that allows us to give surfactant to babies who are receiving 'non-invasive' breathing support (ie HHFNC) and, thus, avoiding the complications related to mechanical ventilation. A small tube is passed into the windpipe whilst the baby is awake and breathing (supported on HHFNC or CPAP) and the surfactant is slowly given and breathed into the lungs. At the moment, there have been no research studies assessing the use of LISA in more mature infants receiving HHFNC as 'non-invasive' respiratory support.
In this study the investigators want to determine if in babies born between 34 and 38+6 weeks gestation who have breathing problems and receive HHFNC oxygen treatment with LISA within 24 hours of birth will reduce the need for mechanical ventilation. The investigators will also be looking a the length on neonatal unit stay, and the cost of the stay. Lung function of the babies before and after they receive LISA will be measured.
There will be no change in the management of babies taking part in the study. Use of HHFNC, administration of LISA and respiratory monitoring is all part of routine practice. The investigators are asking for consent to analyse the routine monitoring that will be undertaken before, during and after the surfactant administration and follow up on the outcome of the baby after they have had the LISA procedure.
Surfactant is routinely used in babies and there are no extra risks from taking part in this study. HHFNC is routinely used to support babies of this gestational age who require respiratory support. There are no known or expected risks from using HHFNC with LISA but as of yet there have been no studies using this combination.
Giving surfactant may help to avoid mechanical ventilation and its side effects, but this has not been studied before in these gestational ages, hence the need for this study. Theoretically giving surfactant with HHFNC should aid even distribution of surfactant throughout the lungs whilst protecting the lungs from potential damage caused by other forms of non-invasive support such as CPAP but again there is not yet evidence supporting this.
The study will be running at King's College Hospital on the Neonatal Intensive Care Unit at the Denmark hill site and at the Local Neonatal Unit at the Princess Royal Hospital site. The study has received ethical approval and is due to commence imminently (May 2024). The study is aiming to recruit 245 patients which is estimated to take 2yrs and 4 months.
The study is funded by Chiesi Limited. The chief investigator for the study is Theodore Dassios: theodore.dassios@kcl.ac.uk
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a prospective single centre study with a treatment arm and a control group.
| Arm | Type | Receives |
|---|---|---|
| Neonates given LISA during HFNC treatment | Experimental | Procedure: Less invasive surfactant administration during high flow nasal cannula treatmentInfants between 34-38+6 weeks gestation will receive surfactant via less invasive administration whilst on high flow nasal cannula oxygen treatment. They will have respiratory function monitoring before and after LISA. |
| Neonates not given LISA | No intervention | –Infants between 34-38+6 will receive routine care and will not receive surfactant unless intubated. |
Who may qualify
- Ages
- 34 to 38 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born at 34+0 to 38+6 weeks of gestation, requiring resuscitation at birth, but who achieve regular spontaneous breathing and have a heart rate over 100 beats per minute while receiving non-invasive support.
- Infants enrolled in the Surfon trial, born at 34+0 to 38+6 weeks of gestation, who are less than or equal to 24 hours old and exhibit signs of respiratory distress, defined as an FiO2 greater or equal to 0.30 but less than 0.45 needed to maintain an SpO2 greater than or equal to 92% or a clinically significant work of breathing regardless of the FiO2 and a clinical decision to provide non-invasive respiratory support.
Key exclusion criteria (2 listed)
- Infants requiring intubation at birth
- Infants with severe congenital anomalies.
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 |
|---|---|---|
| Less invasive surfactant administration during high flow nasal cannula treatmentSurfactant distilled through a small tube inserted into the windpipe via the mouth whilst the baby is awake and supported with HFNC. | Procedure or surgery | Neonates given LISA during HFNC treatment |
Primary outcome
The percentage of neonates needing invasive ventilation within 72 hours from birth
Time frame: 72 hours from birth
The percentage of babies requiring more respiratory support and therefore needing invasive ventilation within 72 hrs from birth. The percentage from the intervention group will be compared with the control group
8 secondary outcomes
The length of neonatal unit stay
Time frame: The length of time the neonate is in hospital, up to 20 weeks
The cost of stay as estimated via standard NHS tariffs according to level of care
Time frame: The length of time the neonate is in hospital, up to 20 weeks
The lung function parameters two minutes before and two minutes after the administration of LISA
Time frame: The first 24 hours of life
The lung function parameters two minutes before and two minutes after the administration of LISA
Time frame: The first 24 hours of life
The lung function parameters two minutes before and two minutes after the administration of LISA
Time frame: The first 24 hours of life
The lung function parameters two minutes before and two minutes after the administration of LISA
Time frame: The first 24 hours of life
The lung function parameters two minutes before and two minutes after the administration of LISA
Time frame: The first 24 hours of life
The SpO2/FiO2 ratio will be measured two hours after LISA administration
Time frame: The first 24 hours of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 31296694Herting E, Hartel C, Gopel W. Less invasive surfactant administration (LISA): chances and limitations. Arch Dis Child Fetal Neonatal Ed. 2019 Nov;104(6):F655-F659. doi: 10.1136/archdischild-2018-316557. Epub 2019 Jul 11.
- Background: PubMed 34567837Shetty S, Egan H, Cornuaud P, Kulkarni A, Duffy D, Greenough A. Less Invasive Surfactant Administration in Very Prematurely Born Infants. AJP Rep. 2021 Jul;11(3):e119-e122. doi: 10.1055/s-0041-1735632. Epub 2021 Sep 22.
- Background: PubMed 31399490Smithhart W, Wyckoff MH, Kapadia V, Jaleel M, Kakkilaya V, Brown LS, Nelson DB, Brion LP. Delivery Room Continuous Positive Airway Pressure and Pneumothorax. Pediatrics. 2019 Sep;144(3):e20190756. doi: 10.1542/peds.2019-0756. Epub 2019 Aug 9.
- Background: PubMed 17762844Spence KL, Murphy D, Kilian C, McGonigle R, Kilani RA. High-flow nasal cannula as a device to provide continuous positive airway pressure in infants. J Perinatol. 2007 Dec;27(12):772-5. doi: 10.1038/sj.jp.7211828. Epub 2007 Aug 30.
- Derived from this study: PubMed 40550714Jeffreys E, Jenkinson A, Kaltsogianni O, Harris C, Bhat R, Dassios T, Greenough A. Does less invasive surfactant administration during high-flow nasal cannula oxygen treatment reduce the need for invasive ventilation in late preterm and early term born infants with respiratory distress? A study protocol for a single-centre study with a treatment and control arm. BMJ Open. 2025 Jun 23;15(6):e089399. doi: 10.1136/bmjopen-2024-089399.
- Individual participant dataSharing planned: No. The General Data Protection Regulation and Data Protection Act 2018 will be adhered to. Data will be anonymised before being entered into a secure database. Each participant will be issued a unique study identifier number when enrolled and this will be used on all data collection forms. Patient paper data will be stored in a locked filing cabinet in a room that is only accessible to the research team and that is based on the Neonatal Intensive Care Unit facilities at King's College Hospital. De-identified electronic patient data will be stored on encrypted computers or memory stick devices. On completion, the data will be analysed and a final report prepared that could be accessed via the sponsor. The study will be presented at research meetings at King's College Hospital. Anonymised study data will be presented at conferences and published by the investigators in peer reviewed journals. Participants will be notified of the outcome of the study via provision of the publication.
Related trials for Respiratory Distress Syndrome
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingObservational study
Pulmonary Immune Cell-microbiome Interactions in ARDS
ARDS, Human
RecruitingPhase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome, Infections
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
Theodore Dassios, PHD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Less invasive surfactant administration during high flow nasal cannula treatment in people with Respiratory Distress Syndrome and Preterm Pregnancy, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 2 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleanor Jeffreys, MBBS (+447519 974813, eleanor.jeffreys@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of neonates needing invasive ventilation within 72 hours from birth (time frame: 72 hours from birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06421506, which also lists 5 linked publications.
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 6 Aug 2026.