NeonatologyENCP LISANCT07271368
EXTERNAL NEGATIVE PRESSURE DURING LISA
A study testing ENCP in people with Neonatology, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The goal of this clinical trial is to evaluate the feasibility, safety, and preliminary effectiveness of applying external continuous negative pressure (ECNP) during less invasive surfactant administration (LISA) in preterm infants with respiratory distress syndrome (RDS). Read more about this study
- Who is it for?
- Ages 1 hour to 3 days
- Conditions the study is for
- Neonatology
- What is being tested?
- ENCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCzechia
- Study dates
- 17 Mar 2025to 31 Dec 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 1 hour to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants ≥ 32 weeks of gestational age
- FiO₂ > 0.30 for more than 30 minutes on CPAP (6 - 8 cm H₂O) or HFNC (8 l/min)
- Increased work of breathing despite FiO₂ < 0.30
- Birth weight > 800 g
- X-ray confirmed RDS
- Availability of all required devices and appropriately fitting cuirass
Who cannot join
- Requirement for endotracheal intubation or mechanical ventilation prior to surfactant administration
- Major congenital anomalies (cardiac, pulmonary, chromosomal)
- Known or suspected neuromuscular or metabolic disorders
- Lack or withdrawal of informed parental consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Klinika gynekologie, porodnictví a neonatologie
Prague, Praha 2, 128 08
Ján Hlivák, MUDr., 224967470 ext. +420, jan.hlivak@vfn.cz
Tereza Lamberská, MUDr., 224967470 ext. +420, tereza.lamberska@vfn.cz
About this study
Official title: AN EXTERNAL NEGATIVE PRESSURE USE DURING THE LISA PROCEDURE. A FEASIBILITY STUDY
The goal of this clinical trial is to evaluate the feasibility, safety, and preliminary effectiveness of applying external continuous negative pressure (ECNP) during less invasive surfactant administration (LISA) in preterm infants with respiratory distress syndrome (RDS). It will also assess whether ECNP can improve surfactant distribution and reduce procedural complications. The main questions it aims to answer are:
Does ECNP during LISA improve surfactant distribution and oxygenation in preterm infants with RDS?
Read more
Does ECNP reduce the occurrence of complications such as desaturation, bradycardia, or apnea during the procedure?
Does ECNP reduce the need for repeated surfactant administration?
Researchers will evaluate ECNP combined with LISA in preterm infants on HFNC or CPAP to see if it improves outcomes compared to standard methods.
Participants will:
Receive LISA with ECNP support via a soft thoracoabdominal cuirass
Be monitored for procedural complications like desaturation, bradycardia, or apnea
Have their oxygenation levels, surfactant distribution, and need for repeated surfactant doses assessed
Primary Outcome:
The procedure will be considered safe if no more than 20% of participants experience serious adverse events, such as apnea requiring positive pressure ventilation or persistent desaturation.
Secondary Outcomes:
Completion of LISA without interruption due to complications
Reduction of FiO₂ to ≤0.25 within 3 hours post-surfactant administration
Avoidance of repeated surfactant doses via the INSURE method
Read the detailed description
This pilot study evaluates the feasibility, safety, and preliminary effectiveness of applying external continuous negative pressure (ECNP) during less invasive surfactant administration (LISA) in preterm infants with respiratory distress syndrome (RDS) supported by non-invasive respiratory support. ECNP, delivered via a modern negative-pressure ventilation device and a soft thoracoabdominal cuirass, generates a sustained sub-atmospheric pressure around the chest wall. This mode of support is intended to facilitate spontaneous breathing, promote more homogeneous lung inflation, and potentially enhance the distribution of intratracheally delivered surfactant.
LISA using thin catheters is a widely adopted method for surfactant administration in spontaneously breathing neonates receiving CPAP or HFNC. Although effective, the procedure is frequently complicated by transient hypoxemia, bradycardia, apnea, and surfactant reflux, occasionally requiring temporary interruption or conversion to more invasive therapy. These complications may impair surfactant delivery, contribute to uneven lung aeration, and lead to the need for repeated dosing. To date, the integration of continuous negative-pressure support during LISA has not been evaluated in clinical practice.
In this single-arm feasibility study, ECNP will be initiated shortly before and maintained throughout the LISA procedure. The study will assess whether negative-pressure support stabilizes spontaneous ventilation, improves oxygenation, and facilitates more uniform surfactant distribution during administration. Safety will be evaluated based on the occurrence of serious procedure-related events requiring interruption, such as significant desaturation, bradycardia, or apnea requiring positive-pressure ventilation. Effectiveness will be explored through measures of post-procedure oxygenation stability, need for repeat surfactant dosing, and indicators of adequate surfactant distribution (e.g., imaging assessments when clinically indicated).
This exploratory study is designed to inform the potential utility of ECNP as an adjunct during LISA and to determine whether a larger controlled trial is warranted. The protocol focuses on documenting feasibility (ability to complete LISA under ECNP), characterizing physiologic responses, and capturing any adverse events specifically associated with ECNP use in this population
- Conditions
- Neonatology
- Being tested
- ENCP
- Keywords
- LISA, negative pressure, neonatology, preterm, surfactant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENCPProcedure or surgery
Surfactant will be given in two doses within 2 minutes while continuous negative pressure is applied using the Hayek RTX thoracoabdominal cuirass. Negative pressure will be maintained during and for 10 minutes after administration.
| Study group | Role | What they receive |
|---|---|---|
| ENCP LISA | Experimental | Infants will remain on CPAP (6-8 cm H₂O) or HFNC (8 L/min) with FiO₂ titrated to maintain SpO₂ ≥92%. LISA catheter will be introduced under direct laryngoscopic vision 1-2 cm below the vocal cords. Two fractional boluses of surfactant (Curosurf, 200 mg/kg) will be administered within 2 minutes during ECNP support using Hayek RTX via a well-fitted thoracoabdominal cuirass. ECNP will be maintained at -10 cmH₂O throughout administration and for 10 minutes after. FiO₂ will not be reduced until SpO₂ stabilizes ≥92% and FiO₂ is ≤0.25. Receives: Procedure: ENCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the procedure
No more than 20% of neonates experience serious adverse events requiring procedural interruption.
Serious adverse events:
- apnea necessitating positive pressure ventilation (PPV) or intubation
- persistent desaturation (SpO₂ < 80%) unresponsive to increased FiO₂
- prolonged bradycardia (heart rate < 100 bpm) requiring interruption of the procedure
- any other adverse event or treatment failure leading to the need for a repeated surfactant administration.
Measured: 15 minutes
Secondary outcomes (1)
Completion of the LISA procedure without interruption
Completion of the LISA procedure without interruption due to desaturation, bradycardia, or apnea, and reduction of FiO₂ to ≤0.25 within 3 hours after surfactant administration.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start17 Mar 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for NeonatologyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Infants will remain on CPAP (6-8 cm H₂O) or HFNC (8 L/min) with FiO₂ titrated to maintain SpO₂ ≥92%. LISA catheter will be introduced under direct laryngoscopic vision 1-2 cm below the vocal cords. Two fractional boluses of surfactant (Curosurf, 200 mg/kg) will be administered within 2 minutes during ECNP support using Hayek RTX via a well-fitted thoracoabdominal cuirass. ECNP will be maintained at -10 cmH₂O throughout administration and for 10 minutes after. FiO₂ will not be reduced until SpO₂ stabilizes ≥92% and FiO₂ is ≤0.25.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ján Hlivák, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271368
- Sponsor's protocol ID
- 117/25 S-IV AP
- Acronym
- ENCP LISA
- Status last verified
- Aug 2026
- First submitted
- 26 Nov 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deep A, De Munter C, Desai A. Negative pressure ventilation in pediatric critical care setting. Indian J Pediatr. 2007 May;74(5):483-8. doi: 10.1007/s12098-007-0082-2.
PubMed 17526961Kribs A, Roll C, Gopel W, Wieg C, Groneck P, Laux R, Teig N, Hoehn T, Bohm W, Welzing L, Vochem M, Hoppenz M, Buhrer C, Mehler K, Stutzer H, Franklin J, Stohr A, Herting E, Roth B; NINSAPP Trial Investigators. Nonintubated Surfactant Application vs Conventional Therapy in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2015 Aug;169(8):723-30. doi: 10.1001/jamapediatrics.2015.0504.
PubMed 26053341Aldana-Aguirre JC, Pinto M, Featherstone RM, Kumar M. Less invasive surfactant administration versus intubation for surfactant delivery in preterm infants with respiratory distress syndrome: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102(1):F17-F23. doi: 10.1136/archdischild-2015-310299. Epub 2016 Nov 15.
PubMed 27852668Dargaville PA, Aiyappan A, Cornelius A, Williams C, De Paoli AG. Preliminary evaluation of a new technique of minimally invasive surfactant therapy. Arch Dis Child Fetal Neonatal Ed. 2011 Jul;96(4):F243-8. doi: 10.1136/adc.2010.192518. Epub 2010 Oct 21.
PubMed 20971722Roberts CT, Halibullah I, Bhatia R, Green EA, Kamlin COF, Davis PG, Manley BJ. Outcomes after Introduction of Minimally Invasive Surfactant Therapy in Two Australian Tertiary Neonatal Units. J Pediatr. 2021 Feb;229:141-146. doi: 10.1016/j.jpeds.2020.10.025. Epub 2020 Oct 14.
PubMed 33068569Dargaville PA, Ali SKM, Jackson HD, Williams C, De Paoli AG. Impact of Minimally Invasive Surfactant Therapy in Preterm Infants at 29-32 Weeks Gestation. Neonatology. 2018;113(1):7-14. doi: 10.1159/000480066. Epub 2017 Sep 19.
PubMed 28922658Kurepa D, Perveen S, Lipener Y, Kakkilaya V. The use of less invasive surfactant administration (LISA) in the United States with review of the literature. J Perinatol. 2019 Mar;39(3):426-432. doi: 10.1038/s41372-018-0302-9. Epub 2019 Jan 11.
PubMed 30635595Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
PubMed 18183564Mohammadizadeh M, Ardestani AG, Sadeghnia AR. Early administration of surfactant via a thin intratracheal catheter in preterm infants with respiratory distress syndrome: Feasibility and outcome. J Res Pharm Pract. 2015 Jan-Mar;4(1):31-6. doi: 10.4103/2279-042X.150053.
PubMed 25710048Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014 Jul 3;15:264. doi: 10.1186/1745-6215-15-264.
PubMed 24993581Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AN EXTERNAL NEGATIVE PRESSURE USE DURING THE LISA PROCEDURE. A FEASIBILITY STUDY
- ClinicalTrials.gov ID
- NCT07271368
- Acronym / sponsor ID
- ENCP LISA / 117/25 S-IV AP
- Conditions
- Neonatology
- Keywords
- LISA, negative pressure, neonatology, preterm, surfactant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Dec 2025 (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 goal of this clinical trial is to evaluate the feasibility, safety, and preliminary effectiveness of applying external continuous negative pressure (ECNP) during less invasive surfactant administration (LISA) in preterm infants with respiratory distress syndrome (RDS). It will also assess whether ECNP can improve surfactant distribution and reduce procedural complications. The main questions it aims to answer are:
Does ECNP during LISA improve surfactant distribution and oxygenation in preterm infants with RDS?
Does ECNP reduce the occurrence of complications such as desaturation, bradycardia, or apnea during the procedure?
Does ECNP reduce the need for repeated surfactant administration?
Researchers will evaluate ECNP combined with LISA in preterm infants on HFNC or CPAP to see if it improves outcomes compared to standard methods.
Participants will:
Receive LISA with ECNP support via a soft thoracoabdominal cuirass
Be monitored for procedural complications like desaturation, bradycardia, or apnea
Have their oxygenation levels, surfactant distribution, and need for repeated surfactant doses assessed
Primary Outcome:
The procedure will be considered safe if no more than 20% of participants experience serious adverse events, such as apnea requiring positive pressure ventilation or persistent desaturation.
Secondary Outcomes:
Completion of LISA without interruption due to complications
Reduction of FiO₂ to ≤0.25 within 3 hours post-surfactant administration
Avoidance of repeated surfactant doses via the INSURE method
Detailed description
This pilot study evaluates the feasibility, safety, and preliminary effectiveness of applying external continuous negative pressure (ECNP) during less invasive surfactant administration (LISA) in preterm infants with respiratory distress syndrome (RDS) supported by non-invasive respiratory support. ECNP, delivered via a modern negative-pressure ventilation device and a soft thoracoabdominal cuirass, generates a sustained sub-atmospheric pressure around the chest wall. This mode of support is intended to facilitate spontaneous breathing, promote more homogeneous lung inflation, and potentially enhance the distribution of intratracheally delivered surfactant.
LISA using thin catheters is a widely adopted method for surfactant administration in spontaneously breathing neonates receiving CPAP or HFNC. Although effective, the procedure is frequently complicated by transient hypoxemia, bradycardia, apnea, and surfactant reflux, occasionally requiring temporary interruption or conversion to more invasive therapy. These complications may impair surfactant delivery, contribute to uneven lung aeration, and lead to the need for repeated dosing. To date, the integration of continuous negative-pressure support during LISA has not been evaluated in clinical practice.
In this single-arm feasibility study, ECNP will be initiated shortly before and maintained throughout the LISA procedure. The study will assess whether negative-pressure support stabilizes spontaneous ventilation, improves oxygenation, and facilitates more uniform surfactant distribution during administration. Safety will be evaluated based on the occurrence of serious procedure-related events requiring interruption, such as significant desaturation, bradycardia, or apnea requiring positive-pressure ventilation. Effectiveness will be explored through measures of post-procedure oxygenation stability, need for repeat surfactant dosing, and indicators of adequate surfactant distribution (e.g., imaging assessments when clinically indicated).
This exploratory study is designed to inform the potential utility of ECNP as an adjunct during LISA and to determine whether a larger controlled trial is warranted. The protocol focuses on documenting feasibility (ability to complete LISA under ECNP), characterizing physiologic responses, and capturing any adverse events specifically associated with ECNP use in this population
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Infants will remain on CPAP (6-8 cm H₂O) or HFNC (8 L/min) with FiO₂ titrated to maintain SpO₂ ≥92%. LISA catheter will be introduced under direct laryngoscopic vision 1-2 cm below the vocal cords. Two fractional boluses of surfactant (Curosurf, 200 mg/kg) will be administered within 2 minutes during ECNP support using Hayek RTX via a well-fitted thoracoabdominal cuirass. ECNP will be maintained at -10 cmH₂O throughout administration and for 10 minutes after. FiO₂ will not be reduced until SpO₂ stabilizes ≥92% and FiO₂ is ≤0.25.
| Arm | Type | Receives |
|---|---|---|
| ENCP LISA | Experimental | Procedure: ENCPInfants will remain on CPAP (6-8 cm H₂O) or HFNC (8 L/min) with FiO₂ titrated to maintain SpO₂ ≥92%. LISA catheter will be introduced under direct laryngoscopic vision 1-2 cm below the vocal cords. Two fractional boluses of surfactant (Curosurf, 200 mg/kg) will be administered within 2 minutes during ECNP support using Hayek RTX via a well-fitted thoracoabdominal cuirass. ECNP will be maintained at -10 cmH₂O throughout administration and for 10 minutes after. FiO₂ will not be reduced until SpO₂ stabilizes ≥92% and FiO₂ is ≤0.25. |
Who may qualify
- Ages
- 1 hour to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Preterm infants ≥ 32 weeks of gestational age
- FiO₂ > 0.30 for more than 30 minutes on CPAP (6 - 8 cm H₂O) or HFNC (8 l/min)
- Increased work of breathing despite FiO₂ < 0.30
- Birth weight > 800 g
- X-ray confirmed RDS
Key exclusion criteria (4 listed)
- Requirement for endotracheal intubation or mechanical ventilation prior to surfactant administration
- Major congenital anomalies (cardiac, pulmonary, chromosomal)
- Known or suspected neuromuscular or metabolic disorders
- Lack or withdrawal of informed parental consent
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 |
|---|---|---|
| ENCPSurfactant will be given in two doses within 2 minutes while continuous negative pressure is applied using the Hayek RTX thoracoabdominal cuirass. Negative pressure will be maintained during and for 10 minutes after administration. | Procedure or surgery | ENCP LISA |
Primary outcome
Safety of the procedure
Time frame: 15 minutes
No more than 20% of neonates experience serious adverse events requiring procedural interruption. Serious adverse events: * apnea necessitating positive pressure ventilation (PPV) or intubation * persistent desaturation (SpO₂ < 80%) unresponsive to increased FiO₂ * prolonged bradycardia (heart rate < 100 bpm) requiring interruption of the procedure * any other adverse event or treatment failure leading to the need for a repeated surfactant administration.
1 secondary outcome
Completion of the LISA procedure without interruption
Time frame: 3 hours
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 21 Aug 2026.
- Background: PubMed 17526961Deep A, De Munter C, Desai A. Negative pressure ventilation in pediatric critical care setting. Indian J Pediatr. 2007 May;74(5):483-8. doi: 10.1007/s12098-007-0082-2.
- Background: PubMed 26053341Kribs A, Roll C, Gopel W, Wieg C, Groneck P, Laux R, Teig N, Hoehn T, Bohm W, Welzing L, Vochem M, Hoppenz M, Buhrer C, Mehler K, Stutzer H, Franklin J, Stohr A, Herting E, Roth B; NINSAPP Trial Investigators. Nonintubated Surfactant Application vs Conventional Therapy in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2015 Aug;169(8):723-30. doi: 10.1001/jamapediatrics.2015.0504.
- Background: PubMed 27852668Aldana-Aguirre JC, Pinto M, Featherstone RM, Kumar M. Less invasive surfactant administration versus intubation for surfactant delivery in preterm infants with respiratory distress syndrome: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102(1):F17-F23. doi: 10.1136/archdischild-2015-310299. Epub 2016 Nov 15.
- Background: PubMed 20971722Dargaville PA, Aiyappan A, Cornelius A, Williams C, De Paoli AG. Preliminary evaluation of a new technique of minimally invasive surfactant therapy. Arch Dis Child Fetal Neonatal Ed. 2011 Jul;96(4):F243-8. doi: 10.1136/adc.2010.192518. Epub 2010 Oct 21.
- Background: PubMed 33068569Roberts CT, Halibullah I, Bhatia R, Green EA, Kamlin COF, Davis PG, Manley BJ. Outcomes after Introduction of Minimally Invasive Surfactant Therapy in Two Australian Tertiary Neonatal Units. J Pediatr. 2021 Feb;229:141-146. doi: 10.1016/j.jpeds.2020.10.025. Epub 2020 Oct 14.
- Background: PubMed 28922658Dargaville PA, Ali SKM, Jackson HD, Williams C, De Paoli AG. Impact of Minimally Invasive Surfactant Therapy in Preterm Infants at 29-32 Weeks Gestation. Neonatology. 2018;113(1):7-14. doi: 10.1159/000480066. Epub 2017 Sep 19.
- Background: PubMed 30635595Kurepa D, Perveen S, Lipener Y, Kakkilaya V. The use of less invasive surfactant administration (LISA) in the United States with review of the literature. J Perinatol. 2019 Mar;39(3):426-432. doi: 10.1038/s41372-018-0302-9. Epub 2019 Jan 11.
- Background: PubMed 18183564Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
- Background: PubMed 25710048Mohammadizadeh M, Ardestani AG, Sadeghnia AR. Early administration of surfactant via a thin intratracheal catheter in preterm infants with respiratory distress syndrome: Feasibility and outcome. J Res Pharm Pract. 2015 Jan-Mar;4(1):31-6. doi: 10.4103/2279-042X.150053.
- Background: PubMed 24993581Teare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014 Jul 3;15:264. doi: 10.1186/1745-6215-15-264.
- Background: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
- Individual participant dataSharing planned: No
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History of Neonatology
Oral History
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 ENCP in people with Neonatology, run by Charles University, Czech Republic at 1 site in Czechia.
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 6 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: looking for participants now, as of the sponsor's last update on 21 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 Czechia. 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 Ján Hlivák, MUDr. (+420774221805, jan.hlivak@vfn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the procedure (time frame: 15 minutes). 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 NCT07271368, which also lists 11 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 21 Aug 2026.