Status:
COMPLETED
Sweetheart Study: Oral Glucose for Reducing Stress During Echocardiographic Assessment in Infants in the NICU
Lead Sponsor:
Children's & Women's Health Centre of British Columbia
Conditions:
Cardiac Echocardiography Assessment
Eligibility:
All Genders
Up to 6 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
One hundred and four infants were randomized to one of four groups during a single np-ECHO examination, at the discretion of the medical team. Randomization to soother and water (Control) with and wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01253889
Start Date
December 1 2010
End Date
June 1 2013
Last Update
February 23 2017
Active Locations (1)
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1
Children's & Women's Health Centre of BC
Vancouver, British Columbia, Canada