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Completed

NCT Number: NCT01253889

Sweetheart Study: Oral Glucose for Reducing Stress During Echocardiographic Assessment 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).

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Key information

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's & Women's Health Centre of BC

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glucose 25% oral solution

Drug

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

Oral water

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to complete a standard ECHO

    Time frame: study day 1

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

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

    Time frame: study day 1

  3. Quality of np-ECHO images assessed by blinded cardiologists

    Time frame: study day 1

  4. Mean heart rate from baseline to end of ECHO

    Time frame: study day 1

  5. Cardiorespiratory instability

    Time frame: study day 1

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 6, 2010
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.