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

Salzburger Landeskliniken

Status

Completed

Conditions

Neonatology

Perinatal Distress Syndrome

Treatments

Device: Surfactant Administration

Study type

Interventional

Funder types

Other

Identifiers

NCT05024435

415-E/2532/7-2019

Details and patient eligibility

About

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

Full 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.

Enrollment

31 patients

Sex

All

Volunteers

No 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)