Clinical trial NCT01253889: Sweetheart Study: Oral Glucose for Reducing Stress During Echocardiographic Assessment in Infants in the NICU
Official title: Glucose 25% and Facilitated Tucking for Reducing Procedural Stress During Neonatologist-performed Cardiac Echocardiography in Infants in the NICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Echocardiography Assessment
Keywords: Functional echocardiography
oral glucose
neonatal stress
Lead sponsor: Children's & Women's Health Centre of British Columbia
Sponsor class: OTHER
First posted: 2010-12-06
Enrollment: 104
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in Behavioral Indicators of Infant Pain (BIIP) Score
timeFrame: study day 1
Secondary outcomes:
measure: Time to complete a standard ECHO
timeFrame: study day 1
measure: Total number of times solutions are given to infants (max 4 times)
timeFrame: study day 1
measure: Quality of np-ECHO images assessed by blinded cardiologists
timeFrame: study day 1
measure: Mean heart rate from baseline to end of ECHO
timeFrame: study day 1
measure: Cardiorespiratory instability
timeFrame: study day 1
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Children's & Women's Health Centre of BC
state: British Columbia
Study officials:
References:
citation: Lavoie PM, Stritzke A, Ting J, Jabr M, Jain A, Kwan E, Chakkarapani E, Brooks P, Brant R, McNamara PJ, Holsti L. A Randomized Controlled Trial of the Use of Oral Glucose with or without Gentle Facilitated Tucking of Infants during Neonatal Echocardiography. PLoS One. 2015 Oct 23;10(10):e0141015. doi: 10.1371/journal.pone.0141015. eCollection 2015.