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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-04-30

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.

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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.

Conditions

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Neonatology Perinatal Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasogastric Tube

Group Type EXPERIMENTAL

Surfactant Administration

Intervention Type DEVICE

Laryngoscopy, intratracheal catheter placement and surfactant administration

Lisacath

Group Type EXPERIMENTAL

Surfactant Administration

Intervention Type DEVICE

Laryngoscopy, intratracheal catheter placement and surfactant administration

Interventions

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Surfactant Administration

Laryngoscopy, intratracheal catheter placement and surfactant administration

Intervention Type DEVICE

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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No