Infant, Premature, DiseasesPALISANCT06150586
Pain Assessment During Less-Invasive-Surfactant-Administration
An observational study of Infant, Premature, Diseases and Respiratory Distress Syndrome, run by University of Zurich at 1 site in Switzerland.
Trial summary
Primary aims of the study are to evaluate the feasibility of Skin conductance (SC) measurements and its correlation to Neonatal Pain and Distress Scale (N-PASS) - scores during the Less-Invasive-Surfactant-Administration (LISA)-procedure in preterm infants. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal
- What is being tested?
- Skin Conductance (SC) Measurement and Video Recording
- Type of treatment
- Pill or oral medicine
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Dec 2023to 17 Jun 2024
- Phase
- Observational
- 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 48 hours
- All sexes
- No healthy volunteers
- Child
Study population: All preterm infants with ≥27 0/7 weeks of gestation at birth who meet the inclusion criteria and who do not fulfill the exclusion criteria
Who may be able to join
- Preterm infants ≥27 0/7 weeks of gestation at birth
- Need for surfactant therapy via LISA according to the local standard operating procedure
- ≥27 0/7 weeks of gestation,
- within first 48 hours of life
- FiO2 ≥0.30 to maintain SpO2 ≥90% for 15 min,
- non-invasive respiratory support with PEEP 6-8 cmH2O
- consent of attending NICU staff for videorecording
Who cannot join
- Primary intubation in the delivery room
- Severe congenital malformation or other conditions requiring immediate endotracheal intubation
- Insufficient language skills (German or English) of the parents to understand and consent the participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The PALISA Study - Pain Assessment During Less-Invasive-Surfactant-Administration
Primary aims of the study are to evaluate the feasibility of Skin conductance (SC) measurements and its correlation to Neonatal Pain and Distress Scale (N-PASS) - scores during the Less-Invasive-Surfactant-Administration (LISA)-procedure in preterm infants. Secondary aims are to evaluate the effect of LISA on the general stress-level in preterm infants with respiratory distress syndrome.
The assessment of pain and stress with SC measurement in addition to the subjective assessment with N-PASS may provide more conclusive data on the sensation of pain or stress during the LISA procedure and therefore the necessity of analgosedation. Therefore, this study might help to identify those infants in need for analgosedation, which would allow an individualized approach in the future.
- Conditions
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Pain, Stress
- Being tested
- Skin Conductance (SC) Measurement, Video Recording
- Keywords
- Less-Invasive-Surfactant-Administration, Skin Conductance, Neonatal Pain and Sedation Scale, Analgosedation, General stress-level
- Medical subject headings
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Pulmonary Atelectasis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Conductance (SC) MeasurementOther
SC will be measured using a specific monitor and three self-adhesive electrodes on one foot of the infant (one plantar and two on the ankles). Peaks per second (the rate of firing in the sympathetic nerves), average amplitude (mean peaks) and area under curve (forcefulness of sympathetic nerve firing) will be automatically analyzed. Corresponding data will be transferred to a separate tablet computer via bluetooth.
Video RecordingOther
The video recording for later N-PASS assessment will be done by a camera fixed above the incubator / resuscitation unit, not interfering with the LISA procedure. The video will show the full body of the newborn as well as the hands / forearms of the treating clinical team with the awareness and oral consent of the treating team.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants with minimal gestational age of 27 weeks requiring LISA | LISA will be preformed according to our local standard protocol while measuring skin conductance via a specific monitor. At the same time a video is recorded for later unblinded and blinded N-PASS assessment. Receives: Other: Skin Conductance (SC) Measurement; Other: Video Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median peaks per second at prespecified time-points adjusted for median peaks per second at baseline
The prespecified time-points are:
- baseline: before starting of interventions (2 minutes recording without any intervention);
- insertion of nasopharyngeal tube;
- insertion of laryngoscope for visualization of the vocal cords;
- insertion of LISA catheter
- administration of surfactant
- removal of catheter
- 5 minutes after removal of catheter (2 minutes recording without any intervention)
- 1 hour (±10 minutes) after LISA (2 minutes recording without any intervention)
Measured: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Secondary outcomes (24)
Median Neonatal Pain, Agitation and Sedation Scale (N-PASS) at prespecified time-points, adjusted for median N-PASS at baseline
The N-PASS serves as a tool for evaluating pain and sedation levels in newborns. In the context of this study, the focus is solely on assessing pain. Five criteria, including crying, behavior, facial expression, extremity tone and vital signs, are rated on a scale of 0 to 2 points each. These individual scores are then added up to calculate a total pain score, which falls within the range of 0 to 10. A higher total score correlates with a higher level of perceived pain.
The prespecified time-points, at which the N-PASS will be assessed, are:
- baseline: before starting of interventions
- during insertion of laryngoscope for visualization of the vocal cords
- administration of surfactant
- 5 minutes after removal of catheter
- 1 hour (±10 minutes) after LISA
Measured: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Absolute number of apneas
Absolute number of apneas requiring non-invasive pressure ventilation or increase of peak inspiratory pressure or frequency during the LISA procedure
Measured: During LISA procedure
Absolute number of desaturations
Absolute number of decreasing SpO2 requiring increase of FiO2 during the LISA procedure
Measured: During LISA procedure
Absolute number of bradycardia
Absolute number of bradycardia (<100/min) during the LISA procedure
Measured: During LISA procedure
Absolute number of arterial hypotension
Absolute number of arterial hypotension with mean blood pressure lower than gestational age during the LISA procedure
Measured: During LISA procedure
Absolute number of blunt surfactant reflux
Absolute number of blunt surfactant reflux seen in mouth or nose without laryngoscopy during the LISA procedure
Measured: During LISA procedure
Difference in maximum peaks per second before and after apnea
Difference in maximum peaks per second before and after apnea requiring non-invasive pressure ventilation or increase of peak inspiratory pressure or frequency during the LISA procedure
Measured: During LISA procedure
Difference in median peaks per second during 20-second interval before and after apnea
Difference in median peaks per second during 20-second interval before and after apnea requiring non-invasive pressure ventilation or increase of peak inspiratory pressure or frequency during the LISA procedure
Measured: During LISA procedure
Difference in maximum peaks per second before and after desaturation
Difference in maximum peaks per second before and after decreasing SpO2 requiring increase of FiO2 during the LISA procedure
Measured: During LISA procedure
Difference in median peaks per second during 20-second interval before and after desaturation
Difference in median peaks per second during 20-second interval before and after decreasing SpO2 requiring increase of FiO2 during the LISA procedure
Measured: During LISA procedure
Difference in maximum peaks per second before and after bradycardia
Difference in maximum peaks per second before and after bradycardia (<100/min) during the LISA procedure
Measured: During LISA procedure
Difference in median peaks per second during 20-second interval before and after bradycardia
Difference in median peaks per second during 20-second interval before and after bradycardia (<100/min) during the LISA procedure
Measured: During LISA procedure
Difference in maximum peaks per second before and after arterial hypotension
Difference in maximum peaks per second before and after arterial hypotension with mean blood pressure lower than gestational age during the LISA procedure
Measured: During LISA procedure
Difference in median peaks per second during 20-second interval before and after arterial hypotension
Difference in median peaks per second during 20-second interval before and after arterial hypotension with mean blood pressure lower than gestational age during the LISA procedure
Measured: During LISA procedure
Difference in maximum peaks per second before and after blunt surfactant reflux
Difference in maximum peaks per second before and after blunt surfactant reflux seen in mouth or nose without laryngoscopy during the LISA procedure
Measured: During LISA procedure
Difference in median peaks per second during 20-second interval before and after blunt surfactant reflux
Difference in median peaks per second during 20-second interval before and after blunt surfactant reflux seen in mouth or nose without laryngoscopy during the LISA procedure
Measured: During LISA procedure
Difference in heart-rate between baseline and prespecified time-points as listed above.
Difference in heart-rate between baseline and prespecified time-points as listed above 2 minutes before LISA, during LISA and 1 hour (±10 minutes) after LISA
Measured: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Difference in oxygen saturation between baseline and prespecified time-points as listed above.
Difference in oxygen saturation between baseline and prespecified time-points as listed above 2 minutes before LISA, during LISA and 1 hour (±10 minutes) after LISA
Measured: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Difference in SpO2/FiO2-ratio between baseline and prespecified time-points as listed above.
Difference in SpO2/FiO2-ratio between baseline and prespecified time-points as listed above 2 minutes before LISA, during LISA and 1 hour (±10 minutes) after LISA
Measured: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Difference of SpO2/FiO2-ratio compared to skin conductance peaks per second
Difference of SpO2/FiO2-ratio at baseline, 5 minutes after removal of catheter and 60 minutes after LISA compared to skin conductance peaks per second (median peaks per second of 2 minute intervals).
Measured: 2 minutes before LISA, 5 minutes after removal of catheter, 60 Minutes after LISA
LISA failure
Incidence of LISA failure defined as intubation or repeated LISA within 24 hours
Measured: Within 24 hours after LISA
Intubation <72 hours after the LISA procedure
Incidence of intubation within <72 hours after the LISA procedure
Measured: Within 72 hours after LISA
Air-leaks <72 hours after the LISA procedure
Incidence of air-leaks within <72 hours after the LISA procedure
Measured: Within 72 hours after LISA
Incidence of intraventricular hemorrhage
Incidence of intraventricular hemorrhage at first ultrasound scan after 72 hours
Measured: 72 hours after LISA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start5 Dec 2023
- Primary completion14 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Bassler, MD, Study chair, Newborn Research, Department of Neonatology, University Hospital and University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150586
- Sponsor's protocol ID
- PALISA
- Acronym
- PALISA
- Status last verified
- Feb 2026
- First submitted
- 20 Nov 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peterson J, den Boer MC, Roehr CC. To Sedate or Not to Sedate for Less Invasive Surfactant Administration: An Ethical Approach. Neonatology. 2021;118(6):639-646. doi: 10.1159/000519283. Epub 2021 Oct 8.
PubMed 34628413Tribolet S, Hennuy N, Snyers D, Lefebvre C, Rigo V. Analgosedation before Less-Invasive Surfactant Administration: A Systematic Review. Neonatology. 2022;119(2):137-150. doi: 10.1159/000521553. Epub 2022 Feb 4.
PubMed 35124678Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.
PubMed 18165830Hummel P, Lawlor-Klean P, Weiss MG. Validity and reliability of the N-PASS assessment tool with acute pain. J Perinatol. 2010 Jul;30(7):474-8. doi: 10.1038/jp.2009.185. Epub 2009 Nov 19.
PubMed 19924132Munsters J, Wallstrom L, Agren J, Norsted T, Sindelar R. Skin conductance measurements as pain assessment in newborn infants born at 22-27 weeks gestational age at different postnatal age. Early Hum Dev. 2012 Jan;88(1):21-6. doi: 10.1016/j.earlhumdev.2011.06.010. Epub 2011 Jul 20.
PubMed 21764228Storm H. Skin conductance and the stress response from heel stick in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F143-7. doi: 10.1136/fn.83.2.f143.
PubMed 10952711Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
PubMed 18997532Morgan ME, Kukora S, Nemshak M, Shuman CJ. Neonatal Pain, Agitation, and Sedation Scale's use, reliability, and validity: a systematic review. J Perinatol. 2020 Dec;40(12):1753-1763. doi: 10.1038/s41372-020-00840-7. Epub 2020 Oct 2.
PubMed 33009491Dirler C, Boos V, Bassler D, Benke-Bruderer S, Held U, Ruegger CM, Muehlbacher T. Pain Assessment During Less Invasive Surfactant Administration Using Skin Conductance: A Prospective Cohort Study. Pediatr Res. 2025 Dec 22. doi: 10.1038/s41390-025-04703-9. Online ahead of print.
PubMed 41429954
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PALISA Study - Pain Assessment During Less-Invasive-Surfactant-Administration
- ClinicalTrials.gov ID
- NCT06150586
- Acronym / sponsor ID
- PALISA / PALISA
- Conditions
- Infant, Premature, Diseases, Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal, Pain, Stress
- Keywords
- Less-Invasive-Surfactant-Administration, Skin Conductance, Neonatal Pain and Sedation Scale, Analgosedation, General stress-level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 29 Nov 2023 (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.
Primary aims of the study are to evaluate the feasibility of Skin conductance (SC) measurements and its correlation to Neonatal Pain and Distress Scale (N-PASS) - scores during the Less-Invasive-Surfactant-Administration (LISA)-procedure in preterm infants. Secondary aims are to evaluate the effect of LISA on the general stress-level in preterm infants with respiratory distress syndrome.
The assessment of pain and stress with SC measurement in addition to the subjective assessment with N-PASS may provide more conclusive data on the sensation of pain or stress during the LISA procedure and therefore the necessity of analgosedation. Therefore, this study might help to identify those infants in need for analgosedation, which would allow an individualized approach in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants with minimal gestational age of 27 weeks requiring LISA | – | Other: Skin Conductance (SC) Measurement, Other: Video RecordingLISA will be preformed according to our local standard protocol while measuring skin conductance via a specific monitor. At the same time a video is recorded for later unblinded and blinded N-PASS assessment. |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All preterm infants with ≥27 0/7 weeks of gestation at birth who meet the inclusion criteria and who do not fulfill the exclusion criteria
Key inclusion criteria (7 listed)
- Preterm infants ≥27 0/7 weeks of gestation at birth
- Need for surfactant therapy via LISA according to the local standard operating procedure
- ≥27 0/7 weeks of gestation,
- within first 48 hours of life
- FiO2 ≥0.30 to maintain SpO2 ≥90% for 15 min,
Key exclusion criteria (3 listed)
- Primary intubation in the delivery room
- Severe congenital malformation or other conditions requiring immediate endotracheal intubation
- Insufficient language skills (German or English) of the parents to understand and consent the participation in the study.
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 |
|---|---|---|
| Skin Conductance (SC) MeasurementSC will be measured using a specific monitor and three self-adhesive electrodes on one foot of the infant (one plantar and two on the ankles). Peaks per second (the rate of firing in the sympathetic nerves), average amplitude (mean peaks) and area under curve (forcefulness of sympathetic nerve firing) will be automatically analyzed. Corresponding data will be transferred to a separate tablet computer via bluetooth. | Other | Preterm infants with minimal gestational age of 27 weeks requiring LISA |
| Video RecordingThe video recording for later N-PASS assessment will be done by a camera fixed above the incubator / resuscitation unit, not interfering with the LISA procedure. The video will show the full body of the newborn as well as the hands / forearms of the treating clinical team with the awareness and oral consent of the treating team. | Other | Preterm infants with minimal gestational age of 27 weeks requiring LISA |
Primary outcome
Median peaks per second at prespecified time-points adjusted for median peaks per second at baseline
Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
The prespecified time-points are: 1. baseline: before starting of interventions (2 minutes recording without any intervention); 2. insertion of nasopharyngeal tube; 3. insertion of laryngoscope for visualization of the vocal cords; 4. insertion of LISA catheter 5. administration of surfactant 6. removal of catheter 7. 5 minutes after removal of catheter (2 minutes recording without any intervention) 8. 1 hour (±10 minutes) after LISA (2 minutes recording without any intervention)
24 secondary outcomes
Median Neonatal Pain, Agitation and Sedation Scale (N-PASS) at prespecified time-points, adjusted for median N-PASS at baseline
Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Absolute number of apneas
Time frame: During LISA procedure
Absolute number of desaturations
Time frame: During LISA procedure
Absolute number of bradycardia
Time frame: During LISA procedure
Absolute number of arterial hypotension
Time frame: During LISA procedure
Absolute number of blunt surfactant reflux
Time frame: During LISA procedure
Difference in maximum peaks per second before and after apnea
Time frame: During LISA procedure
Difference in median peaks per second during 20-second interval before and after apnea
Time frame: During LISA procedure
Difference in maximum peaks per second before and after desaturation
Time frame: During LISA procedure
Difference in median peaks per second during 20-second interval before and after desaturation
Time frame: During LISA procedure
Difference in maximum peaks per second before and after bradycardia
Time frame: During LISA procedure
Difference in median peaks per second during 20-second interval before and after bradycardia
Time frame: During LISA procedure
Difference in maximum peaks per second before and after arterial hypotension
Time frame: During LISA procedure
Difference in median peaks per second during 20-second interval before and after arterial hypotension
Time frame: During LISA procedure
Difference in maximum peaks per second before and after blunt surfactant reflux
Time frame: During LISA procedure
Difference in median peaks per second during 20-second interval before and after blunt surfactant reflux
Time frame: During LISA procedure
Difference in heart-rate between baseline and prespecified time-points as listed above.
Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Difference in oxygen saturation between baseline and prespecified time-points as listed above.
Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Difference in SpO2/FiO2-ratio between baseline and prespecified time-points as listed above.
Time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
Difference of SpO2/FiO2-ratio compared to skin conductance peaks per second
Time frame: 2 minutes before LISA, 5 minutes after removal of catheter, 60 Minutes after LISA
LISA failure
Time frame: Within 24 hours after LISA
Intubation <72 hours after the LISA procedure
Time frame: Within 72 hours after LISA
Air-leaks <72 hours after the LISA procedure
Time frame: Within 72 hours after LISA
Incidence of intraventricular hemorrhage
Time frame: 72 hours after LISA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 34628413Peterson J, den Boer MC, Roehr CC. To Sedate or Not to Sedate for Less Invasive Surfactant Administration: An Ethical Approach. Neonatology. 2021;118(6):639-646. doi: 10.1159/000519283. Epub 2021 Oct 8.
- Background: PubMed 35124678Tribolet S, Hennuy N, Snyers D, Lefebvre C, Rigo V. Analgosedation before Less-Invasive Surfactant Administration: A Systematic Review. Neonatology. 2022;119(2):137-150. doi: 10.1159/000521553. Epub 2022 Feb 4.
- Background: PubMed 18165830Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.
- Background: PubMed 19924132Hummel P, Lawlor-Klean P, Weiss MG. Validity and reliability of the N-PASS assessment tool with acute pain. J Perinatol. 2010 Jul;30(7):474-8. doi: 10.1038/jp.2009.185. Epub 2009 Nov 19.
- Background: PubMed 21764228Munsters J, Wallstrom L, Agren J, Norsted T, Sindelar R. Skin conductance measurements as pain assessment in newborn infants born at 22-27 weeks gestational age at different postnatal age. Early Hum Dev. 2012 Jan;88(1):21-6. doi: 10.1016/j.earlhumdev.2011.06.010. Epub 2011 Jul 20.
- Background: PubMed 10952711Storm H. Skin conductance and the stress response from heel stick in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F143-7. doi: 10.1136/fn.83.2.f143.
- Background: PubMed 18997532Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
- Background: PubMed 33009491Morgan ME, Kukora S, Nemshak M, Shuman CJ. Neonatal Pain, Agitation, and Sedation Scale's use, reliability, and validity: a systematic review. J Perinatol. 2020 Dec;40(12):1753-1763. doi: 10.1038/s41372-020-00840-7. Epub 2020 Oct 2.
- Results publication: PubMed 41429954Dirler C, Boos V, Bassler D, Benke-Bruderer S, Held U, Ruegger CM, Muehlbacher T. Pain Assessment During Less Invasive Surfactant Administration Using Skin Conductance: A Prospective Cohort Study. Pediatr Res. 2025 Dec 22. doi: 10.1038/s41390-025-04703-9. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Dirk Bassler, MD study chair
Newborn Research, Department of Neonatology, University Hospital and University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature, Diseases and Respiratory Distress Syndrome, run by University of Zurich at 1 site in Switzerland.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 10 Feb 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 Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Median peaks per second at prespecified time-points adjusted for median peaks per second at baseline (time frame: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA). 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 NCT06150586, which also lists 9 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 10 Feb 2026.