Sweetheart Study: Oral Glucose for Reducing Stress During Echocardiographic Assessment in Infants in the NICU

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effect of a 25% glucose solution given via a soother with or without facilitated tucking with a similarly administered water placebo (control condition) on infant stress responses during and immediately after a neonatologist performed ECHO (np-ECHO).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's & Women's Health Centre of British Columbia
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Infants born between 26-42 weeks of gestational age admitted to the Neonatal Intensive Care Unit who require a np-ECHO for clinical purposes as indicated by the medical team.

Exclusion Criteria:

• Infants who have congenital anomalies, or a lethal condition in whom intensive care is not indicated;

• Infants below the gestational age of 26 completed weeks;

• Infants who have received analgesics or sedatives within 72 hours of the assessment;

• History of maternal abuse of controlled drugs and substances.

• Infants who are too unstable to receive oral medications or be exposed to a np-ECHO or who already have had an ECHO performed by a Pediatric Cardiologist within 4 hours.