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

Phase 4

Completed

• Conditions: Cardiac Echocardiography Assessment
• Interventions: Drug: Glucose 25% oral solution; Other: Oral water

• Registration Number: NCT01253889
• Lead Sponsor: Children's & Women's Health Centre of British Columbia

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 infant stress responses during and immediately after a neonatologist performed ECHO (np-ECHO).

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 without facilitated tucking or to soother and 25% glucose (Intervention) with or without facilitated tucking will be determined by generating randomly permuted sequential blocks of four and six allocation numbers.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral glucose with soother and tucking	Glucose 25% oral solution	For the infants randomized to receive facilitated tucking throughout the procedure, the bedside nurse will provide gentle, firm containment of the extremities. The facilitated tucking will commence immediately after the baseline BIIP score is taken, but before the glucose/water is administered.
Oral Glucose with soother	Glucose 25% oral solution	Oral Glucose 25% first given two minutes before the first contact by the physician performing the np-ECHO. A soother will be held in the infant's mouth to ensure that continuous contact is maintained throughout the testing period. Repeat application of solution as per study protocol. No other non-pharmaceutical interventions for stress reduction will be applied. During each np-ECHO, infants have additional handling only if it is required to maintain physiological stability.
Oral water with soother and tucking	Oral water	For the infants randomized to receive facilitated tucking throughout the procedure, the bedside nurse will provide gentle, firm containment of the extremities. The facilitated tucking will commence immediately after the baseline BIIP score is taken, but before the glucose/water is administered.
Oral water with soother	Oral water	Oral water first given two minutes before the first contact by the physician performing the np-ECHO. A soother will be held in the infant's mouth to ensure that continuous contact is maintained throughout the testing period. Repeat application of solution as per study protocol. No other non-pharmaceutical interventions for stress reduction will be applied. During each np-ECHO, infants have additional handling only if it is required to maintain physiological stability.

Primary Outcome Measures

Name	Time	Method
Change in Behavioral Indicators of Infant Pain (BIIP) Score	study day 1	The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.

Secondary Outcome Measures

Name	Time	Method
Time to complete a standard ECHO	study day 1	Defined when ultrasound images have been acquired for all four cardiac views
Total number of times solutions are given to infants (max 4 times)	study day 1
Mean heart rate from baseline to end of ECHO	study day 1
Quality of np-ECHO images assessed by blinded cardiologists	study day 1
Cardiorespiratory instability	study day 1

Trial Locations

Locations (1)

Children's & Women's Health Centre of BC; 🇨🇦 Vancouver, British Columbia, Canada