Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants
1 other identifier
interventional
31
1 country
1
Brief Summary
The overall aim of this study is to determine the differences between two surfactant administration catheters in preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedFirst Submitted
Initial submission to the registry
August 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedSeptember 2, 2021
August 1, 2021
6 months
August 23, 2021
August 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful intratracheal tube Placement
Birth to 24 hours after birth
Study Arms (2)
Nasogastric Tube
EXPERIMENTALLisacath
EXPERIMENTALInterventions
Laryngoscopy, intratracheal catheter placement and surfactant administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Salzburger Landeskliniken
Salzburg, 5020, Austria
Related Publications (1)
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.
PMID: 36333741DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Wald, MD, Assoc. Prof.
Paracelsus Medical Private University Salzburg, University Clinic of Pediatrics and Adolescent Medicine Division of Neonatology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, University Hospital Salzburg, Department of Pediatrics and Adolescent Medicine, Physician Division of Neonatology
Study Record Dates
First Submitted
August 23, 2021
First Posted
August 27, 2021
Study Start
November 1, 2019
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
September 2, 2021
Record last verified: 2021-08