RDS of PrematuritySAINTNCT04445571
Surfactant Administration by Insure or Thin Catheter
A study testing Thin catheter technique or standard ET-tube for surfactant administration in people with RDS of Prematurity and Surfactant Deficiency Syndrome Neonatal, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. Read more about this study
- Who is it for?
- Ages Up to 2 days
- Conditions the study is for
- RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Analgesia
- What is being tested?
- Thin catheter technique or standard ET-tube for surfactant administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- 21 May 2021to 31 Dec 2026
- 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 Up to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born before 32 completed weeks of gestation on CPAP, with clinical and radiological signs of RDS and need for surfactant treatment.
Who cannot join
- Infants requiring surfactant as part of delivery room resuscitation are not eligible.
- Infants will be excluded from the final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: congenital diaphragmatic hernia; tracheo-oesophageal fistula or cyanotic heart disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 14186
Kajsa Bohlin, MD, 0858580000 ext. 81356, kajsa.bohlin@ki.se
Mats Blennow, MD, 0858580000 ext. 81428, mats.blennow@ki.se
About this study
This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants.
Read the detailed description
To compare two approaches for surfactant administration during CPAP in preterm infants, the INSURE and the LISA technique, using premedication intubation protocols, and investigate aspects of safety, stress and pain, timely administration of the drug, response in oxygenation and pulmonary outcome.
Our study asks whether (P) among infants born <32 weeks' gestation with RDS (I) does surfactant administration with LISA and analgesia premedication (C) versus surfactant administration according to the INSURE protocol (O) improve oxygenation and reduce the rate of respiratory failure and need for intubation and mechanical ventilation (T) within 48 hours of the procedure
Primary outcomes:
- Positive effect: Oxygenation measured as arterial to alveolar ratio (a/A ratio) at 24 hours post-procedure.
- Negative effect: Need for mechanical ventilation (MV) within 48 hours post-procedure.
Safety outcomes:
- Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration
- Number of tries before successful intubation/placement of catheter
- Positive pressure ventilation during the procedure - yes/no/duration (minutes)
- Stress and pain (changes in heart rate, blood pressure and BIIP-scale)
- Being tested
- Thin catheter technique or standard ET-tube for surfactant administration
- Keywords
- LISA (Less invasive surfactant administration), INSURE, CPAP
- Medical subject headings
- Respiratory Distress Syndrome In Premature Infants, Pulmonary Atelectasis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thin catheter technique or standard ET-tube for surfactant administrationProcedure or surgery
Surfactant administration by intubation with regular ET-tube followed by immediate extubation to CPAP (INSURE) or by thin catheter during spontaneous breathing and continued CPAP.
| Study group | Role | What they receive |
|---|---|---|
| INSURE | Active comparator | Surfactant administration by Intubation-surfactant-extubation to CPAP according to standard protocol including premedication with analgesia and sedation. Receives: Procedure: Thin catheter technique or standard ET-tube for surfactant administration |
| LISA | Active comparator | Surfactant administration by thin catheter during spontaneous breathing and continued CPAP according to set protocol including premedication with analgesia. Receives: Procedure: Thin catheter technique or standard ET-tube for surfactant administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation
Arterial to alveolar ratio (a/A ratio)
Measured: 24 hours post-procedure
Mechanical ventilation
Need for intubation and mechanical ventilation (MV)
Measured: 48 hours post-procedure
Secondary outcomes (4)
Duration of ventilatory support
Duration of MV (hours), CPAP (days), Oxygen (days)
Measured: Discharge
Complications
Incidence of air leaks, bronchopulmonary dysplasia, Systemic hypotension, retinopathy, necrotizing entercolitis, intraventricular hemorrhage, persistent duct
Measured: Discharge
Mortality
Death or composite outcome death/BPD
Measured: Discharge
Length of stay
Number of days in NICU and total in neonatal care, including home care
Measured: Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start21 May 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RDS of PrematurityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kajsa Bohlin, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445571
- Sponsor's protocol ID
- 180367
- Acronym
- SAINT
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2020
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surfactant Administration by Insure or Thin Catheter
- ClinicalTrials.gov ID
- NCT04445571
- Acronym / sponsor ID
- SAINT / 180367
- Keywords
- LISA (Less invasive surfactant administration), INSURE, CPAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jun 2020 (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.
This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants.
Detailed description
To compare two approaches for surfactant administration during CPAP in preterm infants, the INSURE and the LISA technique, using premedication intubation protocols, and investigate aspects of safety, stress and pain, timely administration of the drug, response in oxygenation and pulmonary outcome.
Our study asks whether (P) among infants born <32 weeks' gestation with RDS (I) does surfactant administration with LISA and analgesia premedication (C) versus surfactant administration according to the INSURE protocol (O) improve oxygenation and reduce the rate of respiratory failure and need for intubation and mechanical ventilation (T) within 48 hours of the procedure
Primary outcomes:
- Positive effect: Oxygenation measured as arterial to alveolar ratio (a/A ratio) at 24 hours post-procedure.
- Negative effect: Need for mechanical ventilation (MV) within 48 hours post-procedure.
Safety outcomes:
- Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration
- Number of tries before successful intubation/placement of catheter
- Positive pressure ventilation during the procedure - yes/no/duration (minutes)
- Stress and pain (changes in heart rate, blood pressure and BIIP-scale)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| INSURE | Active comparator | Procedure: Thin catheter technique or standard ET-tube for surfactant administrationSurfactant administration by Intubation-surfactant-extubation to CPAP according to standard protocol including premedication with analgesia and sedation. |
| LISA | Active comparator | Procedure: Thin catheter technique or standard ET-tube for surfactant administrationSurfactant administration by thin catheter during spontaneous breathing and continued CPAP according to set protocol including premedication with analgesia. |
Who may qualify
- Ages
- Up to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants born before 32 completed weeks of gestation on CPAP, with clinical and radiological signs of RDS and need for surfactant treatment.
Key exclusion criteria (2 listed)
- Infants requiring surfactant as part of delivery room resuscitation are not eligible.
- Infants will be excluded from the final analysis if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: congenital diaphragmatic hernia; tracheo-oesophageal fistula or cyanotic heart disease.
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 |
|---|---|---|
| Thin catheter technique or standard ET-tube for surfactant administrationSurfactant administration by intubation with regular ET-tube followed by immediate extubation to CPAP (INSURE) or by thin catheter during spontaneous breathing and continued CPAP. | Procedure or surgery | INSURE, LISA |
Primary outcome
Oxygenation
Time frame: 24 hours post-procedure
Arterial to alveolar ratio (a/A ratio)
Mechanical ventilation
Time frame: 48 hours post-procedure
Need for intubation and mechanical ventilation (MV)
4 secondary outcomes
Duration of ventilatory support
Time frame: Discharge
Complications
Time frame: Discharge
Mortality
Time frame: Discharge
Length of stay
Time frame: Discharge
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 1 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for RDS of Prematurity
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Respiratory Distress Syndrome, Newborn, Infant, Premature
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Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thin catheter technique or standard ET-tube for surfactant administration in people with RDS of Prematurity and Surfactant Deficiency Syndrome Neonatal, run by Karolinska Institutet at 1 site in Sweden.
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 1 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 1 Jul 2025. 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 Sweden. 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 Kajsa Bohlin, MD (+46858580000 ext. 81356, kajsa.bohlin@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation (time frame: 24 hours post-procedure). The study lists 2 primary outcomes in all. 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 1 Jul 2025.