Cardiac Echocardiography Assessment
Conditions
Keywords
Functional echocardiography, oral glucose, neonatal stress
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.
Interventions
DRUGGlucose 25% oral solution
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.
OTHEROral water
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.
Sponsors
Children's & Women's Health Centre of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of np-ECHO images assessed by blinded cardiologists | study day 1 | — |
| Mean heart rate from baseline to end of ECHO | study day 1 | — |
| Cardiorespiratory instability | study day 1 | — |
| Total number of times solutions are given to infants (max 4 times) | study day 1 | — |
| Time to complete a standard ECHO | study day 1 | Defined when ultrasound images have been acquired for all four cardiac views |
Countries
Canada
Outcome results
None listed