Recruiting

Sucrose & Soother

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT05717088

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

24% Sucrose solution

Study Details

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

Study ID

NCT05717088

Start date

Dec 18, 2020

Status verified date

Jan, 2023

Completion date

Apr 1, 2023

Anticipated

Primary completion date

Feb 1, 2023

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria: Patient must meet all inclusion criteria to be eligible for participation that include;

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Premature infant pain profile Score (PIPP) measured in (points 0-21) ranging 0-21 points [ Time Frame: 1 YEAR ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Mar 17, 2023

Last verified

Jan, 2023

Keywords

  • Preterm, Lung, PIPP score, infants, neonates

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2023-03-17.