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

Medical University of Warsaw

Status and phase: Unknown; Phase 1

Conditions: Gestational Age Conditions; Neonatal Respiratory Distress Syndrome

Treatments: Drug: Glucose; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04409665

LISA KGS TRIAL 2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 minute to 4 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Ketamine sedated group

Experimental group

Description:

30 randomized patients will receive Ketamine 1 mg/kg , I.V. 2 minutes before LISA

Treatment:

Drug: Ketamine

Glucose sedated group

Active Comparator group

Description:

30 patients will receive Glucose 30% 1 mL, sublingually, 2 minutes before LISA

Treatment:

Drug: Glucose