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

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

Status and phase: Completed; Phase 4

Conditions: Cardiac Echocardiography Assessment

Treatments: Other: Oral water; Drug: Glucose 25% oral solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01253889

H10-02069

Details and patient eligibility

About

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).

Full 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.

Enrollment: 104 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 4 patient groups, including a placebo group

Oral Glucose with soother

Active Comparator group

Description:

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.

Treatment:

Drug: Glucose 25% oral solution

Oral water with soother

Placebo Comparator group

Description:

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.

Treatment:

Other: Oral water

Oral glucose with soother and tucking

Active Comparator group

Description:

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.

Treatment:

Drug: Glucose 25% oral solution

Oral water with soother and tucking

Placebo Comparator group

Description:

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.

Treatment:

Other: Oral water