Study on the Effects of Different Premedication for LISA on Stress and Cerebral Tissue Oxygenation in Preterm Infants

NCT03718507 | Withdrawn Phase 1

• 1 other identifier: SL2018PS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Given the popularity that LISA technique has gainig in worldwide neonatal units, the lack of evidence regarding its premedication is becoming even more relevant to provide the best care to premature infants. Objective of this clinical trial is to establish the best premedication for LISA procedure considering neonatal pain assessed with premature infants pain scale, salivary cortisol levels as an indicator of stress and crSO2 values as indicators of cerebral oxygenation. Moreover, we aim to verify if sucrose 24% given orally is an effective tool for pain management in preterm neonates also in more invasive procedure, comparable to pharmacological treatment.

Conditions

Respiratory Distress Syndrome; Surfactant Deficiency Syndrome Neonatal; Near Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

• PIPP SCALE score

  Verify which is the best premedication for LISA procedure to reduce neonatal pain.

  during the LISA procedure

Study Arms (2)

GROUP Fentanyl

ACTIVE COMPARATOR

patients will receive atropine (0.01-0.02 mg/kg i.v. bolus) and fentanyl (0.5-2 mcg/kg i.v. in 5 minutes) before LISA in addition to standard care (wrapping). NIRS will be monitored during the whole procedure, which will be video-recorded.

Drug: Fentanyl

GROUP Sucrose

EXPERIMENTAL

patients will be given atropine (0.01-0.02 mg/kg i.v. bolus) and oral sucrose 24% (0.5 ml) 2 minutes before LISA in addition to standard care (wrapping). NIRS will be monitored during the whole procedure, which will be video-recorded.

Drug: Sucrose 24% Oral Solution

Interventions

Fentanyl DRUG

atropine (0.01-0.02 mg/kg i.v. bolus) and fentanyl (0.5-2 mcg/kg i.v. in 5 minutes)

Also known as: atropine

GROUP Fentanyl

Sucrose 24% Oral Solution DRUG

0.5 ml given orally 2 minutes before LISA procedure

Also known as: atropine

GROUP Sucrose

Eligibility Criteria

• Age: 27 Weeks - 29 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonate 27-29+6 weeks AND
• Need for non-invasive respiratory support (CPAP or nHFT) AND
• Need for surfactant according to the unit guidelines AND
• Written informed consent

You may not qualify if:

• No written informed consent and/or
• Severe malformation of the upper/lower airways, brain and/or heart and/or lung and/or prenatal cerebral injury.

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pulmonary Atelectasis

Interventions

Fentanyl; Atropine; Sucrose; Solutions

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 24, 2018
• Study Start: May 20, 2019
• Primary Completion: December 20, 2019
• Study Completion: February 20, 2020
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share