Dexmedetomidine for LISA Procedure in Preterm Infants

NCT04820101 | Unknown

• 1 other identifier: DEXLISA 920/CE Marca
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

RDS

Keywords

RDS; LISA; preterm; sedation; dexmedetomidine

Outcome Measures

Primary Outcomes (2)

• effectiveness of dexmedetomidine in achieving sedation for LISA 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

  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 Outcomes (16)

• number of laryngoscopies needed to perform LISA

  during the procedure

• time needed to perform LISA

  during the procedure

• Intubation conditions

  during the procedure

• the evolution of cardiorespiratory parameters

  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

  1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection

Study Arms (1)

Every preterm newborns 26+0 -36+6 wGA with RDS needing surfactant therapy

EXPERIMENTAL

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

Interventions

Dexmedetomidine DRUG

administrating dexmedetomidine in order to evaluate the efficacy in achieving sedation for LISA procedure

Also known as: LISA procedure

Every preterm newborns 26+0 -36+6 wGA with RDS needing surfactant therapy

Eligibility Criteria

• Age: 26 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Need for emergency intubation in the delivery room
• Major congenital malformations (such as cardiopathies)
• Chromosomic abnormalities
• Fetal Hydrops
• Hypercapnia: CO2 \> 65 mmHg
• Pneumothorax
• Hemodynamic compromise

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Paola Lago

Treviso, 31100, Italy

Location

Related Publications (24)

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  PMID: 30974433 RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Paola Lago, MD

CONTACT

00390422322608; paola.lago@aulss2.veneto.it

Beatrice Galeazzo, MD

CONTACT

00390422322608; beatrice.galeazzo@aulss2.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neonatal Intensive Care Unit, Principal Investigator

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 29, 2021
• Study Start: May 15, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: at the end of the study (April 2023)
• Access Criteria: The investigators will access the data and the statistician

Locations

IT (1)