Dexmedetomidine for LISA Procedure in Preterm Infants (DEXLISA)

April 27, 2021 updated by: Paola Lago, University of Padova

Dexmedetomidine for LISA Procedure in Preterm Infants: a Pilot Study

The investigators aim to evaluate: the effectiveness of dexmedetomidine for analgesia and sedation during LISA procedure, without compromising the respiratory drive; the safety of this drug on the preterm infant in a pilot study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Information will be given to parents of preterm babies <36 wGA upon their admission to the NICU (neonatal intensive care unit), and informed consent will be obtained as soon as possible. Eligible babies for LISA procedure (dyspneic and FiO2 > 0.30 on CPAP pressure of at least 6 cmH2O) undergo sedation with dexmedetomidine 1 mcg/kg, administered slowly iv in 10 minutes, together with non pharmacological techniques. After the step of sedation LISA is performed. Before/during and after the procedure pain will be assessed by the NIPS scale and the quality of intubation will be evaluated; then other events related to the procedure will be strictly collected for the first 24 hours. Babies will then be managed in usual NICU way and clinical data will be unregistered on respiratory, neurological and hemodynamic outcomes during the hospital stay, and especially at discharge.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Treviso, Italy, 31100
        • Paola Lago
        • Contact:
        • Sub-Investigator:
          • Beatrice Galeazzo, MD
        • Sub-Investigator:
          • Nadia Battajon, MD
        • Sub-Investigator:
          • Valentina Favero, MD
        • Sub-Investigator:
          • Silvia Vendramin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 months to 8 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Preterm newborns between 26+0 and 36+6 weeks of gestation stratified in two groups: VLBWI 26-31+6and LBWI 32-36+6.
  2. Respiratory distress syndrome requiring surfactant therapy

Exclusion Criteria:

  1. Need for emergency intubation in the delivery room
  2. Major congenital malformations (such as cardiopathies)
  3. Chromosomic abnormalities
  4. Fetal Hydrops
  5. Hypercapnia: CO2 > 65 mmHg
  6. Pneumothorax
  7. Hemodynamic compromise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Every preterm newborns 26+0 -36+6 wGA with RDS needing surfactant therapy
Every preterm newborns 26+0-36+6 wGA who undergoes LISA procedure will receive sedation with dexmedetomidine in order to evaluate its efficacy in achieving pain control and comfort.
Drug: Dexmedetomidine
administrating dexmedetomidine in order to evaluate the efficacy in achieving sedation for LISA procedure
Other Names:
  • LISA procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
effectiveness of dexmedetomidine in achieving sedation for LISA procedure
Time Frame: basal (before procedure), during and immediately after the procedure
evaluation of changes in Neonatal Infant Pain Scale (NIPS) score (0-2 points= no pain, 3-4 points = moderate pain; > 4 = severe pain)
basal (before procedure), during and immediately after the procedure
Safety of dexmedetomidine in sedating preterm infants
Time Frame: 24 hours
evaluation of number of apneas ( > 20 seconds or < 20 seconds with bradycardia < 100 bpm or desaturation ( SpO2 < 85%)); number of severe apnea and bradycardia (defined by the American Academy of Pediatrics Guidelines as apnea > 30 seconds and/or heart rate < 60 beats/minute for more than 10 seconds); need for intubation.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
number of laryngoscopies needed to perform LISA
Time Frame: during the procedure
calculate the number of laryngoscopies needed to perform LISA
during the procedure
time needed to perform LISA
Time Frame: during the procedure
calculate the time needed to perform LISA
during the procedure
Intubation conditions
Time Frame: during the procedure
evaluated by the operator using the Goldberg scale (3 = excellent intubation conditions; 4-6= good intubation conditions; 7-9 = poor intubation conditions; 10-12 = inadequate intubation conditions)
during the procedure
the evolution of cardiorespiratory parameters
Time Frame: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
heart rate (beats per minute)
1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
the evolution of cardiorespiratory parameters
Time Frame: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
respiratory rate (breaths per minute)
1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
the evolution of cardiorespiratory parameters
Time Frame: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
pulse oximetry (%)
1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
the evolution of cardiorespiratory parameters
Time Frame: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
blood pressure (mmHg)
1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
the evolution of cardiorespiratory parameters
Time Frame: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
FiO2 maxima during the procedure maintained for at least 30 seconds (%)
1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
changes in ventilation mode
Time Frame: 1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
inspiratory and end-expiratory ventilation pressures changes (cmH2O)
1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection
The incidence of drug adverse effects
Time Frame: 24 hours after drug injection
respiratory events (i.e. bronchospasm) or cardiovascular events (bradycardia, hypotension)
24 hours after drug injection
The incidence of pneumothorax or selective administration of surfactant
Time Frame: 24 hours after drug injection
RX evaluation
24 hours after drug injection
Long term outcomes
Time Frame: at 40 weeks PMA
mortality (%)
at 40 weeks PMA
Long term outcomes
Time Frame: at 40 weeks PMA
bronchopulmonary dysplasia (%), defined as oxygen administration and/or respiratory support at 36 wGA
at 40 weeks PMA
Long term outcomes
Time Frame: at 40 weeks PMA
intraventricular hemorrhage (%) and periventricular leukomalacia (%)
at 40 weeks PMA
Long term outcomes
Time Frame: at 40 weeks PMA
necrotizing enterocolitis (%)
at 40 weeks PMA
Long term outcomes
Time Frame: at 40 weeks PMA
retinopathy of prematurity (%)
at 40 weeks PMA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DEXLISA 920/CE Marca

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

at the end of the study (April 2023)

IPD Sharing Access Criteria

The investigators will access the data and the statistician

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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