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

Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants With Respiratory Distress Syndrome - A Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05024435

Enrollment

Registered

2021-08-27

Start date

2019-11-01

Completion date

2020-04-30

Last updated

2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatology, Perinatal Distress Syndrome

Keywords

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

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.

Interventions

DEVICESurfactant Administration

Laryngoscopy, intratracheal catheter placement and surfactant administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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)

Design outcomes

Primary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026