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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

40

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

May 15, 2021

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

April 1, 2023

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (ACTUAL)

March 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on RDS

Clinical Trials on Dexmedetomidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe