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

Phase 1

• Conditions: Gestational Age Conditions; Neonatal Respiratory Distress Syndrome
• Interventions: Drug: Ketamine; Drug: Glucose

• Registration Number: NCT04409665
• Lead Sponsor: Medical University of Warsaw

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 Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-06-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-16
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-03-31
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine sedated group	Ketamine	30 randomized patients will receive Ketamine 1 mg/kg , I.V. 2 minutes before LISA
Glucose sedated group	Glucose	30 patients will receive Glucose 30% 1 mL, sublingually, 2 minutes before LISA

Primary Outcome Measures

Name	Time	Method
Assessment of patient sedation	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	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.

Secondary Outcome Measures

Name	Time	Method
Frequency of complications	During the procedure	Monitoring the possible side effects of used drugs

Trial Locations

Locations (1)

Uniwersyteckie Centrum Zdrowia Kobiety Noworodka; 🇵🇱 Warsaw, Mazowieckie, Poland