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

NCT04409665 | Unknown Phase 1

• 1 other identifier: LISA KGS TRIAL 2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Respiratory Distress Syndrome; Gestational Age Conditions

Keywords

LISA; LISA sedation; MIST; MIST sedation; Ketamine; Glucose; RDS; Newborn

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Frequency of complications

  During the procedure

Study Arms (2)

Ketamine sedated group

EXPERIMENTAL

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

Drug: Ketamine

Glucose sedated group

ACTIVE COMPARATOR

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

Drug: Glucose

Interventions

Ketamine 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

Ketamine sedated group

Glucose 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

Glucose sedated group

Eligibility Criteria

• Age: 1 Minute - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Need for intubation and mechanical ventilation at the Delivery Room
• Infant with clinically significant maxillo-facial, tracheal or pulmonary malformations

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Uniwersyteckie Centrum Zdrowia Kobiety Noworodka

Warsaw, Masovian Voivodeship, 02-015, Poland

RECRUITING

Related Publications (9)

• McPherson C, Grunau RE. Neonatal pain control and neurologic effects of anesthetics and sedatives in preterm infants. Clin Perinatol. 2014 Mar;41(1):209-27. doi: 10.1016/j.clp.2013.10.002. Epub 2013 Dec 17.

  PMID: 24524456 BACKGROUND

• Kurepa D, Perveen S, Lipener Y, Kakkilaya V. The use of less invasive surfactant administration (LISA) in the United States with review of the literature. J Perinatol. 2019 Mar;39(3):426-432. doi: 10.1038/s41372-018-0302-9. Epub 2019 Jan 11.

  PMID: 30635595 BACKGROUND

• 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.

  PMID: 29532502 BACKGROUND

• Dekker J, Lopriore E, Rijken M, Rijntjes-Jacobs E, Smits-Wintjens V, Te Pas A. Sedation during Minimal Invasive Surfactant Therapy in Preterm Infants. Neonatology. 2016;109(4):308-13. doi: 10.1159/000443823. Epub 2016 Feb 24.

  PMID: 26907795 BACKGROUND

• McPherson C, Inder T. Perinatal and neonatal use of sedation and analgesia. Semin Fetal Neonatal Med. 2017 Oct;22(5):314-320. doi: 10.1016/j.siny.2017.07.007. Epub 2017 Jul 19.

  PMID: 28734732 BACKGROUND

• Allegaert K, van den Anker JN. Neonatal pain management: still in search for the Holy Grail. Int J Clin Pharmacol Ther. 2016 Jul;54(7):514-23. doi: 10.5414/CP202561.

  PMID: 27087155 BACKGROUND

• Fernandez C, Boix H, Camba F, Comunas JJ, Castillo F. Less Invasive Surfactant Administration in Spain: A Survey Regarding Its Practice, the Target Population, and Premedication Use. Am J Perinatol. 2020 Feb;37(3):277-280. doi: 10.1055/s-0039-1678534. Epub 2019 Feb 4.

  PMID: 30716788 BACKGROUND

• 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.

  PMID: 22379381 BACKGROUND

• 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.

  PMID: 19221401 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

Ketamine; Glucose

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Paweł Krajewski, MD, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Piotr Pomianek, MD

CONTACT

502536300; tomek.pomianek@gmail.com

Paweł Krajewski, MD, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the division of neonatology

Model Details: 60 infants randomized 1:1 to receive ketamine or glucose

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 1, 2020
• Study Start: January 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: April 30, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who provides a methodologically sound proposal.

Locations

PL (1)