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

NCT01253889 | Completed Phase 4

• 1 other identifier: H10-02069
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiac Echocardiography Assessment

Keywords

Functional echocardiography; oral glucose; neonatal stress

Outcome Measures

Primary Outcomes (1)

• Change in Behavioral Indicators of Infant Pain (BIIP) Score

  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 Outcomes (5)

• Time to complete a standard ECHO

  study day 1

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

  study day 1

• 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

Study Arms (4)

Oral Glucose with soother

ACTIVE COMPARATOR

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

Oral water with soother

PLACEBO COMPARATOR

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

Oral glucose with soother and tucking

ACTIVE COMPARATOR

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

Oral water with soother and tucking

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: glucose

Oral Glucose with soother; Oral glucose with soother and tucking

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.

Oral water with soother; Oral water with soother and tucking

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's & Women's Health Centre of British Columbia: lead

Study Sites (1)

Children's & Women's Health Centre of BC

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• 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.

  PMID: 26496361 DERIVED

MeSH Terms

Interventions

Glucose; Solutions; Water

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Pharmaceutical Preparations; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tier 2 Canada Research Chair in Neonatal Health and Development

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 6, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

CA (1)