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
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