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

NCT ID: NCT04409665

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2022-04-30

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.

Conditions

Neonatal Respiratory Distress Syndrome; Gestational Age Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Ketamine sedated group

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Glucose sedated group

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

Group Type: ACTIVE_COMPARATOR

Glucose

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

PAWEL KRAJEWSKI, MD

Head of the division of neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paweł Krajewski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

Uniwersyteckie Centrum Zdrowia Kobiety Noworodka

Warsaw, Masovian Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Tomasz Piotr Pomianek, MD

Role: CONTACT

tomek.pomianek@gmail.com

502536300 ext. +48

Paweł Krajewski, MD, PhD

Role: CONTACT

Facility Contacts

Tomasz Pomianek, MD

Role: primary

tomek.pomianek@gmail.com

502536300 ext. +48

Paweł Krajewski, PhD, MD

Role: backup

pawelkrajewski@outlook.com

References

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Reference Type: BACKGROUND

PMID: 24524456 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 30635595 (View on PubMed)

Bourgoin L, Caeymaex L, Decobert F, Jung C, Danan C, Durrmeyer X. Administering atropine and ketamine before less invasive surfactant administration resulted in low pain scores in a prospective study of premature neonates. Acta Paediatr. 2018 Jul;107(7):1184-1190. doi: 10.1111/apa.14317. Epub 2018 Apr 16.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 26907795 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 30716788 (View on PubMed)

Barrington K. Premedication for endotracheal intubation in the newborn infant. Paediatr Child Health. 2011 Mar;16(3):159-71. doi: 10.1093/pch/16.3.159.

Reference Type: BACKGROUND

PMID: 22379381 (View on PubMed)

Milesi C, Cambonie G, Jacquot A, Barbotte E, Mesnage R, Masson F, Pidoux O, Ferragu F, Thevenot P, Mariette JB, Picaud JC. Validation of a neonatal pain scale adapted to the new practices in caring for preterm newborns. Arch Dis Child Fetal Neonatal Ed. 2010 Jul;95(4):F263-6. doi: 10.1136/adc.2008.144758. Epub 2009 Feb 16.

Reference Type: BACKGROUND

PMID: 19221401 (View on PubMed)

Other Identifiers

LISA KGS TRIAL 2020

Identifier Type: -

Identifier Source: org_study_id