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

February 20, 2017 updated by: Liisa Holsti, Children's & Women's Health Centre of British Columbia

Glucose 25% and Facilitated Tucking for Reducing Procedural Stress During Neonatologist-performed Cardiac Echocardiography in Infants in the NICU

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Children's & Women's Health Centre of BC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 (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.
Other Names:
  • 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 (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.
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 (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.
Other Names:
  • 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 (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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Behavioral Indicators of Infant Pain (BIIP) Score
Time Frame: study day 1
The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.
study day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to complete a standard ECHO
Time Frame: study day 1
Defined when ultrasound images have been acquired for all four cardiac views
study day 1
Total number of times solutions are given to infants (max 4 times)
Time Frame: study day 1
study day 1
Quality of np-ECHO images assessed by blinded cardiologists
Time Frame: study day 1
study day 1
Mean heart rate from baseline to end of ECHO
Time Frame: study day 1
study day 1
Cardiorespiratory instability
Time Frame: study day 1
study day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's & Women's Health Centre of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H10-02069

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