The Use of Sedation Drugs in the Procedure of Administering Surfactant Without Intubation (LISA/MIST)

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 second goal is to compare the frequency of complications during LISA with both premedication regimens.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Warsaw
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• Need for intubation and mechanical ventilation at the Delivery Room

• Infant with clinically significant maxillo-facial, tracheal or pulmonary malformations