AzTrials
AzTrials

Neonatal Respiratory Distress SyndromePhase 1LISA KGSNCT04409665

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

A Phase 1 study testing Ketamine and Glucose in people with Neonatal Respiratory Distress Syndrome and Gestational Age Conditions, run by Medical University of Warsaw at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 minute to 4 months
What is being tested?
Ketamine and Glucose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePoland
Study dates
1 Jan 2020to 30 Apr 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 minute to 4 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Tomasz Piotr Pomianek, MD contact

502536300 ext. +48

tomek.pomianek@gmail.com

Paweł Krajewski, MD, PhD contact

Poland1 site, 1 recruiting

  • Uniwersyteckie Centrum Zdrowia Kobiety Noworodka

    Warsaw, Masovian Voivodeship, 02-015

    Tomasz Pomianek, MD, 502536300 ext. +48, tomek.pomianek@gmail.com

    Paweł Krajewski, PhD, MD, pawelkrajewski@outlook.com

    Recruiting

Other trials in Poland

About this study

Official title: 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

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.

Read the 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.

Being tested
Ketamine, Glucose
Keywords
LISA, LISA sedation, MIST, MIST sedation, Ketamine, Glucose, RDS, Newborn
Medical subject headings
Respiratory Distress Syndrome, Newborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

    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

  • GlucoseDrug

    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

Study groups in NCT04409665
Study groupRoleWhat they receive
Ketamine sedated groupExperimental30 randomized patients will receive Ketamine 1 mg/kg , I.V. 2 minutes before LISA
Receives: Drug: Ketamine
Glucose sedated groupActive comparator30 patients will receive Glucose 30% 1 mL, sublingually, 2 minutes before LISA
Receives: Drug: Glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of patient sedation

    Assessment of patient sedation change before and after LISA using COMFORT scale

    Measured: First assessment 10 minutes before procedure, second during the procedure

  2. Assessment of patient sedation

    Assessment of patient sedation change before and after LISA using FANS scale

    Measured: First assessment 10 minutes before procedure, second during the procedure

  3. 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.

    Measured: Comparing the scores through study completion, an average of two years

  4. 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.

    Measured: Comparing the scores through study completion, an average of two years

Secondary outcomes (1)

  1. Frequency of complications

    Monitoring the possible side effects of used drugs

    Measured: During the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2020
  2. Study start1 Jan 2020
  3. Primary completion31 Mar 2022 (estimated)
  4. Study completion30 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
60 infants randomized 1:1 to receive ketamine or glucose
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04409665
Sponsor's protocol ID
LISA KGS TRIAL 2020
Acronym
LISA KGS
Status last verified
Jan 2022
First submitted
20 May 2020
Last updated
19 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial will be available, after de-identification. The study protocol will also be available. These documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.

Publications

  • 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.

    PubMed 24524456

  • 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.

    PubMed 30635595

  • 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.

    PubMed 29532502

  • 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.

    PubMed 26907795

  • 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.

    PubMed 28734732

  • 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.

    PubMed 27087155

  • 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.

    PubMed 30716788

  • 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.

    PubMed 22379381

  • 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.

    PubMed 19221401

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ketamine and Glucose in people with Neonatal Respiratory Distress Syndrome and Gestational Age Conditions, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tomasz Piotr Pomianek, MD (502536300 ext. +48, tomek.pomianek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of patient sedation (time frame: First assessment 10 minutes before procedure, second during the procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04409665, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in