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

Children's & Women's Health Centre of British Columbia104 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

104

Conditions

Cardiac Echocardiography Assessment

Interventions

Glucose 25% oral solutionDRUG

0.5ml of 25% glucose (26-31 weeks gestational age group) or 1.0 ml of 25% glucose (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of 25% glucose in the 26-31 weeks gestational age group or 4ml of 25% glucose in the 32-42 weeks gestational age group.

Oral waterOTHER

0.5ml of oral water (26-31 weeks gestational age group) or 1.0 ml of oral water (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of oral water in the 26-31 weeks gestational age group or 4ml of oral water in the 32-42 weeks gestational age group.

Eligibility

Sex: ALLMax age: 6 Months

Medical Language ↔ Plain English

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.

Locations (1)

Children's & Women's Health Centre of BC

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Change in Behavioral Indicators of Infant Pain (BIIP) Score

The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.

Time frame: study day 1

Secondary Outcomes

Time to complete a standard ECHO

Defined when ultrasound images have been acquired for all four cardiac views

Time frame: study day 1

Total number of times solutions are given to infants (max 4 times)

Time frame: study day 1

Quality of np-ECHO images assessed by blinded cardiologists

Time frame: study day 1

Mean heart rate from baseline to end of ECHO

Time frame: study day 1

Cardiorespiratory instability

Time frame: study day 1

Data from ClinicalTrials.gov

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