CClinicalTrials.gg
Sign In
CompletedNCT05024435Updated Sep 2, 2021

Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants

An interventional study of Surfactant Administration in Neonatology and Perinatal Distress Syndrome, sponsored by Salzburger Landeskliniken. Completed at 1 site in Austria. Per ClinicalTrials.gov, last updated 2021-09-02.

Sponsored by Salzburger Landeskliniken · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Nov 2019, registered Aug 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Sex
All
01

Study summary

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.

02

Conditions studied

  • Neonatology
  • Perinatal Distress Syndrome

Keywords

  • Less Invasive Surfactant Administration
  • Minimal Invasive Surfactant Treatment
  • Preterm Infant
  • Respiratory Distress Syndrome
  • Surfactant
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 31 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Salzburger Landeskliniken is the lead sponsor of 14 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Nasogastric Tube

    Device: Surfactant Administration

  • Experimental
    Lisacath

    Device: Surfactant Administration

Interventions

  • DeviceSurfactant Administration

    Laryngoscopy, intratracheal catheter placement and surfactant administration

06

What researchers measure

Primary outcomes

  1. Successful intratracheal tube Placement

    Time frame: Birth to 24 hours after birth

07

Study locations

1 site
  • Salzburger Landeskliniken
    Salzburg, 5020, Austria
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05024435
Lead sponsor
Salzburger Landeskliniken
Responsible party
Lorenz Auer-Hackenberg (Medical Doctor, University Hospital Salzburg, Department of Pediatrics and Adolescent Medicine, Physician Division of Neonatology, Salzburger Landeskliniken) — Principal investigator
First posted
Aug 27, 2021
Start date
Nov 1, 2019
Primary completion
Apr 30, 2020
Completion
Apr 30, 2020
Last update
Sep 2, 2021

Study contacts

Martin Wald, MD, Assoc. Prof.
principal investigator · Paracelsus Medical Private University Salzburg, University Clinic of Pediatrics and Adolescent Medicine Division of Neonatology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Respiratory Distress Syndrome→

Other studies from this sponsor

Salzburger Landeskliniken

Start the discussion