- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03735563
Premedication for Less Invasive Surfactant Administration (LISA-Med)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All infants fulfilling the inclusion criteria during the study period are asked to participate in this randomized controlled trial of LISA premedication. Written informed parental consent is acquired from all of the participants. After the consent, individuals needing the LISA will receive premedication as follows: caffeine (in case of gestational age <32 weeks and not already given), glycopyrrolate, and randomly either ketamine or fentanyl. The investigators and medical staff are blinded to the fact which study medication is given. This study is a pilot study and 20 patients are recruited for both groups. Randomization is done in the blocks of four.
S-ketamine (Ketanest-S 5 mg/ml) or fentanyl (Fentanyl-Hamel diluted to 5 μg/ml) is used as a masked study drug. Both study drug solutions appear equally transparent. Drug administration is started with glucopyrrolate (Robinul 0.2 mg/ml), which is given intravenously at a dose of 5 µg/kg. Thereafter, the masked study drug is administered intravenously slowly in one to two minute injection of 0.2 ml/kg. In this way, doses of S-ketamine 1 mg/kg or alternatively fentanyl 1 μg/kg is received. After five minutes (from the beginning of administration of the study drug), videolaryngoscopy is started. If the study drug does not have sufficient effect, the study drug may be repeated with the same dose. If study drug fails to give appropriate conditions to LISA procedure, midazolam 0,1 mg/kg can be used as an additional drug.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Eveliina Ronkainen, MD, PhD
- Phone Number: +358 8 3152011
- Email: eveliina.ronkainen@oulu.fi
Study Contact Backup
- Name: Antti Härmä, MD
- Phone Number: +358 8 3152011
- Email: aharma@paju.oulu.fi
Study Locations
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-
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Oulu, Finland
- Recruiting
- Oulu University Hospital
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Contact:
- Eveliina Ronkainen, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Gestational age at birth ≥26 weeks
- Respiratory insufficiency managed with non-invasive respiratory support (nasal continuous positive airway pressure or high-flow)
- Requirement for oxygen to maintain oxygen saturation in the target range and need for surfactant treatment (according to clinician's assessment)
- If further doses of surfactant are needed, patient can be re-randomized
Exclusion Criteria:
- Severe RDS with high oxygen requirements, severe respiratory acidosis and/or widespread atelectasis radiologically, such that ongoing ventilator support will be necessary after surfactant therapy (intubation in preferable to LISA if FiO2 >40% at GA <28 weeks and >60% at GA ≥28 weeks)
- Maxillo-facial, tracheal or known pulmonary malformations
- Any known chromosomal abnormality or severe malformation
- An alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketamine
Individuals needing the LISA will receive premedication as follows: caffeine (in case of gestational age <32 weeks and not already given), glycopyrrolate, and randomly either ketamine or fentanyl.
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Individuals will receive randomly either ketamine or fentanyl as a premedication
Other Names:
|
Experimental: Fentanyl
Individuals needing the LISA will receive premedication as follows: caffeine (in case of gestational age <32 weeks and not already given), glycopyrrolate, and randomly either ketamine or fentanyl.
|
Individuals will receive randomly either ketamine or fentanyl as a premedication
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event
Time Frame: 1 hour
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The need of positive pressure ventilation (PPV), intubation, heart rate below 80 per minute, mean arterial pressure change more than 20%, pH change more than 0.4, and CO2 change more than 20%, and saturation <85 for more than 1 minute
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1 hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of the procedure
Time Frame: 1 hour
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Duration of the procedure is evaluated retrospectively from the recording of the videolaryngoscopy (an attempt begins when the laryngoscope enters the mouth and ends with LISACath in the trachea)
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1 hour
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Number of attempts to get the catether intratracheally
Time Frame: 1 hour
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Number of attempts to get the catether intratracheally is evaluated retrospectively from the recording of the videolaryngoscopy (one laryngoscopy = one attempt)
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1 hour
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Pain score NIAPAS
Time Frame: 1 hour
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Pain will be scored with validated Neonatal Infant Acute Pain Assessment Scale (NIAPAS) tool.
The scale includes five behavioral and three physiological indicators, and takes into account the gestational age of neonates as a contextual factor.
The indicators are rated on a 2, 3, or 4-point scale for a possible total score of 18. Assessments of each neonate include alertness, facial expressions, crying, muscle tension, reaction to handling, and breathing.
In addition, the neonates on monitors are assessed for changes in heart rate and oxygen saturation (Copyright Pölkki T, Korhonen A, Axelin A. 2013)
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1 hour
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The need for additional dosing of study drug or midazolam (number of addtional dosages)
Time Frame: 1 hour
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If the study drug does not have sufficient effect, the study drug may be repeated with the same dose.
If study drug fails to give appropriate conditions to LISA procedure, midazolam 0,1 mg/kg can be used as an additional drug.
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1 hour
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Edi-signals
Time Frame: 1 hour
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Special Edi (Electronic Diaphragm Monitoring) Catheter is placed to read the electrical activity of the diaphragm.
Edi min and Edi max in different time points will be collected.
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1 hour
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Riitta Marttila, MD, docent, Oulu University and Oulu University Hospital
Publications and helpful links
General Publications
- Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.
- Vento M, Dargaville P, Bohlin K, Herting E & Roehr C LISA Training Advisory Board Report.
- Polkki T, Korhonen A, Axelin A, Saarela T, Laukkala H. Development and preliminary validation of the Neonatal Infant Acute Pain Assessment Scale (NIAPAS). Int J Nurs Stud. 2014 Dec;51(12):1585-94. doi: 10.1016/j.ijnurstu.2014.04.001. Epub 2014 Apr 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Infant, Newborn, Diseases
- Infant, Premature, Diseases
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Ketamine
- Fentanyl
Other Study ID Numbers
- OY062018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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