Effectiveness of Oral Sucrose for Preterm Infants Undergoing Point-of-care Lung Ultrasound: A Randomized Controlled Trial

Status: Unknown
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 8 months
Healthy Volunteers: f
View:

• Preterm infants (GA \< 37 weeks) admitted to the neonatal intensive care unit, Mount Sinai Hospital,

• Undergoing LUS for clinical or research purpose,

• Hemodynamically stable (not requiring any circulatory support), and

• Written informed parental consent is obtained.

Locations
Other Locations
Canada
Mount Sinai Hospital
RECRUITING
Toronto
Contact Information
Primary
Adel Mohamed, MD
adel.mohamed@sinaihealth.ca
4165864800
Time Frame
Start Date: 2020-12-18
Completion Date: 2023-04-01
Participants
Target number of participants: 64
Treatments
Experimental: Oral sucrose + soother group (group A)
Group A: Infants will receive oral sucrose (24%) followed by a soother 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.
No_intervention: Soother alone group (group B)
Group B (control group): infants will receive a soother 2 minutes before LUS scan.
Sponsors
Leads: Mount Sinai Hospital, Canada

This content was sourced from clinicaltrials.gov