NeonatologyNCT05024435
Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants
A study testing Surfactant Administration in people with Neonatology and Perinatal Distress Syndrome, run by Salzburger Landeskliniken at 1 site in Austria.
Trial summary
The overall aim of this study is to determine the differences between two surfactant administration catheters in preterm infants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatology, Perinatal Distress Syndrome
- What is being tested?
- Surfactant Administration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2019to 30 Apr 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm infants born less than 37 weeks of gestation
- Treating physician in charge of admission decides to administer intratracheal surfactant via standardized institution- LISA protocol (regardless of this study) (see Supplement file 1)
- Written informed consent signed by caregivers or legal representative to participate
Who cannot join
- Refusal to participate in study or not providing written informed consent by caregivers/parents
- Treating physician decides to use different route of surfactant administration or does not adhere to LISA protocol.
- Rupture of membranes (ROM) at less than 22 weeks of gestation or more than 6 weeks before birth
- Estimated birth weight < 3rd percentile using 2013 Fenton growth trajectories
- Twins with feto-fetal transfusion syndrome (FFTS) and FFTS being the cause of premature delivery
- Contraindications listed in the LISAcath® or Nasogastric Tube manual (esophageal/pharyngeal varices or other vascular lesions, esophageal/pharyngeal tumor, nasal fracture, skull fracture, known allergy to material)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants With Respiratory Distress Syndrome - A Randomized Controlled Trial
The overall aim of this study is to determine the differences between two surfactant administration catheters in preterm infants.
Read the detailed description
In this single-center, open-label, randomized-controlled trial, preterm infants requiring surfactant administration after birth, using a standardized minimal invasive protocol, were randomised to two different modes of endotracheal catheterization: Flexible Ch-4 feeding tube inserted using Magill forceps (group 1) and semi-rigid catheter (group 2). Primary outcome was duration of laryngoscopy. Secondary outcomes were complication rate and vital parameters during laryngoscopy.
- Conditions
- Neonatology, Perinatal Distress Syndrome
- Being tested
- Surfactant Administration
- Keywords
- Less Invasive Surfactant Administration, Minimal Invasive Surfactant Treatment, Preterm Infant, Respiratory Distress Syndrome, Surfactant
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surfactant AdministrationDevice
Laryngoscopy, intratracheal catheter placement and surfactant administration
| Study group | Role | What they receive |
|---|---|---|
| Nasogastric Tube | Experimental | Not described Receives: Device: Surfactant Administration |
| Lisacath | Experimental | Not described Receives: Device: Surfactant Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful intratracheal tube Placement
Measured: Birth to 24 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Nov 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salzburger Landeskliniken
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenz Auer-Hackenberg, Salzburger Landeskliniken
- Investigators
- Martin Wald, MD, Assoc. Prof., Principal investigator, Paracelsus Medical Private University Salzburg, University Clinic of Pediatrics and Adolescent Medicine Division of Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024435
- Sponsor's protocol ID
- 415-E/2532/7-2019
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Auer-Hackenberg L, Brandner J, Hofstatter E, Stroicz P, Hager T, Eichhorn A, Schutz S, Feldner R, Wald M. A pilot study of evaluation of semi-rigid and flexible catheters for less invasive surfactant administration in preterm infants with respiratory distress syndrome-a randomized controlled trial. BMC Pediatr. 2022 Nov 4;22(1):637. doi: 10.1186/s12887-022-03714-3.
PubMed 36333741
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants With Respiratory Distress Syndrome - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05024435
- Acronym / sponsor ID
- 415-E/2532/7-2019
- Conditions
- Neonatology, Perinatal Distress Syndrome
- Keywords
- Less Invasive Surfactant Administration, Minimal Invasive Surfactant Treatment, Preterm Infant, Respiratory Distress Syndrome, Surfactant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Salzburger LandesklinikenUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 27 Aug 2021 (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 overall aim of this study is to determine the differences between two surfactant administration catheters in preterm infants.
Detailed description
In this single-center, open-label, randomized-controlled trial, preterm infants requiring surfactant administration after birth, using a standardized minimal invasive protocol, were randomised to two different modes of endotracheal catheterization: Flexible Ch-4 feeding tube inserted using Magill forceps (group 1) and semi-rigid catheter (group 2). Primary outcome was duration of laryngoscopy. Secondary outcomes were complication rate and vital parameters during laryngoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasogastric Tube | Experimental | Device: Surfactant Administration |
| Lisacath | Experimental | Device: Surfactant Administration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preterm infants born less than 37 weeks of gestation
- Treating physician in charge of admission decides to administer intratracheal surfactant via standardized institution- LISA protocol (regardless of this study) (see Supplement file 1)
- Written informed consent signed by caregivers or legal representative to participate
Key exclusion criteria (6 listed)
- Refusal to participate in study or not providing written informed consent by caregivers/parents
- Treating physician decides to use different route of surfactant administration or does not adhere to LISA protocol.
- Rupture of membranes (ROM) at less than 22 weeks of gestation or more than 6 weeks before birth
- Estimated birth weight < 3rd percentile using 2013 Fenton growth trajectories
- Twins with feto-fetal transfusion syndrome (FFTS) and FFTS being the cause of premature delivery
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 |
|---|---|---|
| Surfactant AdministrationLaryngoscopy, intratracheal catheter placement and surfactant administration | Device | Lisacath, Nasogastric Tube |
Primary outcome
Successful intratracheal tube Placement
Time frame: Birth to 24 hours after birth
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 2 Sep 2021.
- Derived from this study: PubMed 36333741Auer-Hackenberg L, Brandner J, Hofstatter E, Stroicz P, Hager T, Eichhorn A, Schutz S, Feldner R, Wald M. A pilot study of evaluation of semi-rigid and flexible catheters for less invasive surfactant administration in preterm infants with respiratory distress syndrome-a randomized controlled trial. BMC Pediatr. 2022 Nov 4;22(1):637. doi: 10.1186/s12887-022-03714-3.
- Individual participant dataSharing planned: Undecided
Related trials for Neonatology
RecruitingObservational study
Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections
Neonatal Infection
Not yet recruiting
Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
Vascular Access Devices, Vascular Access
Not yet recruitingPhase 2/3
Dexmedetomidine for Invasive Ventilation In the NEOnate
Invasive Ventilation, Infant Pain
Recruiting
EXTERNAL NEGATIVE PRESSURE DURING LISA
Neonatology
Recruiting
NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn Infants
Neonatal Intensive Care
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.
Martin Wald, MD, Assoc. Prof. principal investigator
Paracelsus Medical Private University Salzburg, University Clinic of Pediatrics and Adolescent Medicine Division of Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surfactant Administration in people with Neonatology and Perinatal Distress Syndrome, run by Salzburger Landeskliniken at 1 site in Austria.
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 3 inclusion and 6 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 2 Sep 2021. 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 Austria. 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?
Successful intratracheal tube Placement (time frame: Birth to 24 hours after 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 NCT05024435, which also lists 1 linked publication.
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 2 Sep 2021.