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

NCT03718507 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-08-04

No results posted yet for this study

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

Interventions

DRUG

Fentanyl

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

DRUG

Sucrose 24% Oral Solution

0.5 ml given orally 2 minutes before LISA procedure

Sponsors & Collaborators

  • ASST Fatebenefratelli Sacco

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
27 Weeks
Max Age
29 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2019-12-20
Completion
2020-02-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03718507 on ClinicalTrials.gov