Effectiveness of Oral Sucrose During Lung Ultrasound

NCT05717088 | Unknown

• 1 other identifier: 20-0220-E
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Keywords

Preterm, Lung, PIPP score, infants, neonates

Outcome Measures

Primary Outcomes (1)

• Premature infant pain profile Score (PIPP) measured in (points 0-21) ranging 0-21 points

  To compare the changes in the Pain Score "Premature infant pain profile Score (PIPP)" at 4 time points between infants receiving oral sucrose solution + Pacifier versus Pacifier alone. PIPP score ranges from 0-21 points, where 0 means no pain and 21 is severe pain.

  1 YEAR

Secondary Outcomes (1)

• Total time to complete the scan (minutes)

  1 YEAR

Study Arms (2)

Oral sucrose + soother group (group A)

EXPERIMENTAL

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.

Other: 24% Sucrose solution

Soother alone group (group B)

NO INTERVENTION

Group B (control group): infants will receive a soother 2 minutes before LUS scan.

Interventions

24% Sucrose solution OTHER

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.

Oral sucrose + soother group (group A)

Eligibility Criteria

• Age: 0 Days - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Infants with neurological disorders, congenital anomalies that interfere with oral intake,
• On pain medications, or
• receiving nothing per oral because of medical condition e.g. necrotizing enterocolitis are excluded

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

RECRUITING

MeSH Terms

Conditions

Pain; Premature Birth

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Adel Mohamed, MD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adel Mohamed, MD

CONTACT

4165864800; adel.mohamed@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The random numbers will be placed in sequentially numbered, sealed, opaque envelopes and will be opened after obtaining informed consent and just before the procedure by one of the study investigators to ensure allocation concealment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 8, 2023
• Study Start: December 18, 2020
• Primary Completion: February 1, 2023
• Study Completion: April 1, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-01

Locations

CA (1)