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Recruiting NCT05717088

Effectiveness of Oral Sucrose During Lung Ultrasound

Conditions: Pain

Sex: All
Ages: 0 Days – 37 Weeks
Phase: NA
Enrollment: 64
Sponsor: Mount Sinai Hospital, Canada

Location: Canada

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 Criteria

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), andWritten informed parental consent is obtained.Exclusion Criteria:Infants with neurological disorders, congenital anomalies that interfere with oral intake,On pain medications, orreceiving nothing per oral because of medical condition e.g. necrotizing enterocolitis are excluded

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05717088). StuddyBuddy aggregates publicly available trial information.