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Effectiveness of Oral Sucrose During Lung Ultrasound

NCT05717088 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-03-17

No results posted yet for this study

Summary

Background: control of pain in neonates has an important role in preventing long- term effects on neurodevelopment and pain reactivity. Oral sucrose and non-nutritive suckling are considered a non-pharmacological treatment that has many advantages. Currently, there is controversy regarding the use of sucrose during point of care lung ultrasound (LUS) scan as many consider LUS is not a painful procedure.

Objective: Determine the efficacy of oral sucrose solution + soother versus soother alone in reducing infant's agitation during LUS scan Method: This is a blinded, prospective, parallel group randomized controlled trial comparing the Premature infant pain profile (PIPP) score in infants randomized to receive oral sucrose followed by soother soother vs. soother alone while having LUS scan Study outcomes: The primary outcome of this study is to compare the changes in PIPP scores at 4 time points between infants receiving oral sucrose solution + soother versus soother alone. The secondary outcomes are 1) total time to complete a standard LUS scan from start of scanning to the end, 2) Association of LUS with adverse events e.g., episodes of desaturation, tachycardia, bradycardia or apnea.

Conditions

Interventions

OTHER

24% Sucrose solution

Infants will either receive oral sucrose (24%) 2 minutes before the procedure "LUS scan". The dose will be 0.2 mL, 0.5 mL and 1 mL for infants with current weight \< 1500g, 1500-2500g, and \> 2500g respectively.

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Adel Mohamed, MD · Sinai Health System

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-18
Primary Completion
2023-02-01
Completion
2023-04-01

Countries

  • Canada

Study Locations

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Entities

Diseases

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 NCT05717088 on ClinicalTrials.gov