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

Study Overview
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Brief Summary
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The overall aim of this study is to determine the differences between two surfactant administration catheters in preterm infants.

Detailed Description
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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.

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

Conditions
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Neonatology, Perinatal Distress Syndrome

Intervention / Treatment
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* Device: Surfactant Administration


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasogastric Tube<br> | Device: Surfactant Administration<br>* Laryngoscopy, intratracheal catheter placement and surfactant administration<br>|
| Experimental: Lisacath<br> | Device: Surfactant Administration<br>* Laryngoscopy, intratracheal catheter placement and surfactant administration<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Less Invasive Surfactant Administration, Minimal Invasive Surfactant Treatment, Preterm Infant, Respiratory Distress Syndrome, Surfactant