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

Primary Purpose

Neonatology, Perinatal Distress Syndrome

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Surfactant Administration

About this trial

This is an interventional treatment trial for Neonatology focused on measuring Less Invasive Surfactant Administration, Minimal Invasive Surfactant Treatment, Preterm Infant, Respiratory Distress Syndrome, Surfactant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Salzburger Landeskliniken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Nasogastric Tube

Lisacath

Arm Description

Outcomes

Primary Outcome Measures

Successful intratracheal tube Placement

Secondary Outcome Measures

Full Information

NCT ID

NCT05024435

First Posted

August 23, 2021

Last Updated

August 27, 2021

Sponsor

Salzburger Landeskliniken

1. Study Identification

Unique Protocol Identification Number

NCT05024435

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Salzburger Landeskliniken

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neonatology, Perinatal Distress Syndrome

Keywords

Less Invasive Surfactant Administration, Minimal Invasive Surfactant Treatment, Preterm Infant, Respiratory Distress Syndrome, Surfactant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nasogastric Tube

Arm Type

Experimental

Arm Title

Lisacath

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Surfactant Administration

Intervention Description

Laryngoscopy, intratracheal catheter placement and surfactant administration

Primary Outcome Measure Information:

Title

Successful intratracheal tube Placement

Time Frame

Birth to 24 hours after birth

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Wald, MD, Assoc. Prof.

Organizational Affiliation

Paracelsus Medical Private University Salzburg, University Clinic of Pediatrics and Adolescent Medicine Division of Neonatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Salzburger Landeskliniken

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

36333741

Citation

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.

Results Reference

derived

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

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