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

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ClinicalTrials.gov Identifier: NCT04409665
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
PAWEL KRAJEWSKI, MD, Medical University of Warsaw

Tracking Information
First Submitted Date  ICMJE May 20, 2020
First Posted Date  ICMJE June 1, 2020
Last Update Posted Date June 1, 2020
Actual Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
  • Assessment of patient sedation [ Time Frame: First assessment 10 minutes before procedure, second during the procedure ]
    Assessment of patient sedation change before and after LISA using COMFORT scale
  • Assessment of patient sedation [ Time Frame: First assessment 10 minutes before procedure, second during the procedure ]
    Assessment of patient sedation change before and after LISA using FANS scale
  • Comparing ketamine and glucose [ Time Frame: Comparing the scores through study completion, an average of two years ]
    Comparison of the effectiveness of sedation with ketamine and glucose using the FANS scale scores. The FANS scale ranges from 0 points at minimum to 10 points at maximum. The higher the score, the lower the sedation.
  • Comparing ketamine and glucose [ Time Frame: Comparing the scores through study completion, an average of two years ]
    Comparison of the effectiveness of sedation with ketamine and glucose using the COMFORT scale scores. The Comfort scale ranges from 8 points at minimum, to 40 at maximum. The higher the score, the lower the sedation level.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
Frequency of complications [ Time Frame: During the procedure ]
Monitoring the possible side effects of used drugs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Sedation Drugs in the Procedure of Administering Surfactant Without Intubation (LISA/MIST)
Official Title  ICMJE The Use of Sedation Drugs in the Procedure of Administering Surfactant Without Intubation (LISA/MIST): a Randomized Study Comparing Intravenous Ketamine With Sublingual 30% Glucose
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 second goal is to compare the frequency of complications during LISA with both premedication regimens.
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 will be acquired from parents or legal guardians. After the consent, infants needing the LISA will receive premedication as follows: caffeine citrate according to the clinical routine at study site, and randomly, either ketamine or sublingual glucose 30%. This study is a pilot study and 60 patients that will be randomized 1:1. Ketamine will be given in slow intravenous injection over 60 seconds. Glucose 30% will be given sublingually in the volume of 1 mL. After two minutes (from the end of administration of the study drug or reference drug), laryngoscopy will be started. To assess the effectiveness of both types of sedation, patients will be assessed using two pain assessment scales - the COMFORT scale and the FANS scale. 10 minutes before the procedure, the first assessment in the COMFORT and FANS scales will take place. The next assessment on both scales will take place during the procedure.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
60 infants randomized 1:1 to receive ketamine or glucose
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Neonatal Respiratory Distress Syndrome
  • Gestational Age Conditions
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Ketamine sedated group
    30 randomized patients will receive Ketamine 1 mg/kg , I.V. 2 minutes before LISA
    Intervention: Drug: Ketamine
  • Active Comparator: Glucose sedated group
    30 patients will receive Glucose 30% 1 mL, sublingually, 2 minutes before LISA
    Intervention: Drug: Glucose
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 26, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 4 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tomasz Piotr Pomianek, MD 502536300 ext +48 tomek.pomianek@gmail.com
Contact: Paweł Krajewski, MD, PhD
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04409665
Other Study ID Numbers  ICMJE LISA KGS TRIAL 2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial will be available, after de-identification. The study protocol will also be available. These documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.
Supporting Materials: Study Protocol
Time Frame: Immediately following publication. No end date.
Access Criteria: Anyone who provides a methodologically sound proposal.
Responsible Party PAWEL KRAJEWSKI, MD, Medical University of Warsaw
Study Sponsor  ICMJE Medical University of Warsaw
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paweł Krajewski, MD, PhD Medical University of Warsaw
PRS Account Medical University of Warsaw
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP