Status:
UNKNOWN
The Use of Sedation Drugs in the Procedure of Administering Surfactant Without Intubation (LISA/MIST)
Lead Sponsor:
Medical University of Warsaw
Conditions:
Neonatal Respiratory Distress Syndrome
Gestational Age Conditions
Eligibility:
All Genders
1-4 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the efficacy and impact of intravenous ketamine or sublingual 30% glucose as sedation drugs used in preterm premature babies during the LISA procedure. The sec...
Detailed Description
All infants fulfilling the inclusion criteria during the 12 months recruitment window will potentially be enrolled in this randomized controlled trial of LISA premedication. Written informed consent w...
Eligibility Criteria
Inclusion
- Infant with established Respiratory Distress Syndrome (RDS) or at risk for RDS
- Gestational age 28 0/7 - 32 6/7 weeks
- Non-invasive respiratory support with nasal CPAP (incl. BiPAP) or NIPPV
- Need for administration of exogenous surfactant
Exclusion
- Need for intubation and mechanical ventilation at the Delivery Room
- Infant with clinically significant maxillo-facial, tracheal or pulmonary malformations
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04409665
Start Date
January 1 2020
End Date
April 30 2022
Last Update
January 19 2022
Active Locations (1)
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1
Uniwersyteckie Centrum Zdrowia Kobiety Noworodka
Warsaw, Masovian Voivodeship, Poland, 02-015