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

NCT04409665 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-01-19

No results posted yet for this study

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.

Conditions

  • Neonatal Respiratory Distress Syndrome
  • Gestational Age Conditions

Interventions

DRUG

Ketamine

Patient will be sedated using Ketamine 2 minutes before the LISA procedure. 10 minutes prior the procedure and during the procedure the patient's pain and/or discomfort will be evaluated using COMFORT and FANS scales

DRUG

Glucose

Patient will be sedated using Glucose 2 minutes before the LISA procedure. 10 minutes prior the procedure and during the procedure the patient's pain and/or discomfort will be evaluated using COMFORT and FANS scales

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Paweł Krajewski, MD, PhD · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-03-31
Completion
2022-04-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04409665 on ClinicalTrials.gov