Clinical trial NCT05024435: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neonatology
Perinatal Distress Syndrome
Keywords: Less Invasive Surfactant Administration
Minimal Invasive Surfactant Treatment
Preterm Infant
Respiratory Distress Syndrome
Surfactant
Lead sponsor: Salzburger Landeskliniken
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Successful intratracheal tube Placement
timeFrame: Birth to 24 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
Study officials:
affiliation: Paracelsus Medical Private University Salzburg, University Clinic of Pediatrics and Adolescent Medicine Division of Neonatology
name: Martin Wald, MD, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.