Evaluation of Semi-rigid and Flexible Catheters for Less... | NCT05024435

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

NCT05024435

Sponsor

Salzburger Landeskliniken

Status

Completed

Last Update Posted

Sep 2, 2021Actual

Enrollment

31Actual

Phase

Not Applicable

Conditions

Neonatology
Perinatal Distress Syndrome

Interventions

Surfactant Administration

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

Apr 30, 2020Actual

Completion Date

Apr 30, 2020Actual

First Submitted Date

Aug 23, 2021

First Submission Date that Met QC Criteria

Aug 23, 2021

First Posted Date

Aug 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2021

Last Update Posted Date

Sep 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lorenz Auer-Hackenberg, Medical Doctor, University Hospital Salzburg, Department of Pediatrics and Adolescent Medicine, Physician Division of Neonatology, Salzburger LandesklinikenPrincipal Investigator

Lead Sponsor

Salzburger LandesklinikenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nasogastric Tube	Experimental		Device: Surfactant Administration
Lisacath	Experimental		Device: Surfactant Administration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surfactant Administration	Device	Laryngoscopy, intratracheal catheter placement and surfactant administration	Lisacath Nasogastric Tube

Measure	Description	Time Frame
Successful intratracheal tube Placement		Birth to 24 hours after birth

Eligibility Module

Eligibility Criteria

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:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Wald, MD, Assoc. Prof.	Paracelsus Medical Private University Salzburg, University Clinic of Pediatrics and Adolescent Medicine Division of Neonatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Salzburger Landeskliniken		Salzburg		5020	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36333741	Derived	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.

ID	Term
D047928	Premature Birth
D012128	Respiratory Distress Syndrome

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications