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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Neonatal Respiratory Distress Syndrome, Gestational Age Conditions

Intervention / Treatment
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* Drug: Ketamine
* Drug: Glucose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 60 infants randomized 1:1 to receive ketamine or glucose
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine sedated group<br>30 randomized patients will receive Ketamine 1 mg/kg , I.V. 2 minutes before LISA | Drug: Ketamine<br>* 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<br>|
| Active Comparator: Glucose sedated group<br>30 patients will receive Glucose 30% 1 mL, sublingually, 2 minutes before LISA | Drug: Glucose<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of patient sedation | Assessment of patient sedation change before and after LISA using COMFORT scale | First assessment 10 minutes before procedure, second during the procedure | 
| Assessment of patient sedation | Assessment of patient sedation change before and after LISA using FANS scale | First assessment 10 minutes before procedure, second during the procedure | 
| Comparing ketamine and glucose | 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 the scores through study completion, an average of two years | 
| Comparing ketamine and glucose | 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. | Comparing the scores through study completion, an average of two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of complications | Monitoring the possible side effects of used drugs | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LISA, LISA sedation, MIST, MIST sedation, Ketamine, Glucose, RDS, Newborn