Sweetheart Study: Oral Glucose for Reducing Stress During Echocardiographic Assessment in Infants in the NICU - Full Text View

Purpose

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).

Condition	Intervention	Phase
Cardiac Echocardiography Assessment	Drug: Glucose 25% oral solution Other: Oral water	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Glucose 25% and Facilitated Tucking for Reducing Procedural Stress During Neonatologist-performed Cardiac Echocardiography in Infants in the NICU

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by Children's & Women's Health Centre of British Columbia:

Primary Outcome Measures:

Change in Behavioral Indicators of Infant Pain (BIIP) Score [ Time Frame: during assessment ] [ Designated as safety issue: No ]
The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.

Secondary Outcome Measures:

Time to complete a standard ECHO [ Time Frame: end of assessment ] [ Designated as safety issue: No ]
Defined when ultrasound images have been acquired for all four cardiac views
Total number of times solutions are given to infants (max 4 times) [ Time Frame: end of assessment ] [ Designated as safety issue: No ]
Quality of np-ECHO images assessed by blinded cardiologists [ Time Frame: end of assessment ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	December 2010
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Oral Glucose with soother 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.	Drug: Glucose 25% oral solution 0.5ml of 25% glucose (27-31 weeks gestational age group) or 1.0 ml of 25% glucose (32-40 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 27-31 weeks gestational age group or 4ml of 25% glucose in the 32-40 weeks gestational age group. Other Name: glucose
Placebo Comparator: Oral water with soother 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.	Other: Oral water 0.5ml of oral water (27-31 weeks gestational age group) or 1.0 ml of oral water (32-40 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 27-31 weeks gestational age group or 4ml of oral water in the 32-40 weeks gestational age group.
Active Comparator: Oral glucose with soother and tucking 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.	Drug: Glucose 25% oral solution 0.5ml of 25% glucose (27-31 weeks gestational age group) or 1.0 ml of 25% glucose (32-40 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 27-31 weeks gestational age group or 4ml of 25% glucose in the 32-40 weeks gestational age group. Other Name: glucose
Placebo Comparator: Oral water with soother and tucking 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.	Other: Oral water 0.5ml of oral water (27-31 weeks gestational age group) or 1.0 ml of oral water (32-40 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 27-31 weeks gestational age group or 4ml of oral water in the 32-40 weeks gestational age group.

Detailed Description:

Ninety infants will be 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

Ages Eligible for Study:	up to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Infants born between 27-40 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 27 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 be exposed to a np-ECHO or who already have an ECHO performed by a Pediatric Cardiologist within 4 hours.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253889

Locations

Canada, British Columbia
Children's & Women's Health Centre of BC	Recruiting
Vancouver, British Columbia, Canada
Contact: Liisa Holsti, MD lholsti@cw.bc.ca
Principal Investigator: Liisa Holsti, PhD
Sub-Investigator: Amelie Stritzke, MD

Sponsors and Collaborators

Children's & Women's Health Centre of British Columbia

More Information

No publications provided

Responsible Party:	Dr. Liisa Holsti, University of British Columbia
ClinicalTrials.gov Identifier:	NCT01253889 History of Changes
Other Study ID Numbers:	H10-02069
Study First Received:	December 2, 2010
Last Updated:	September 8, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Children's & Women's Health Centre of British Columbia:

Functional echocardiography
oral glucose
neonatal stress

ClinicalTrials.gov processed this record on May 16, 2013