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

• 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 ]

• 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: study end ] [ Designated as safety issue: No ]

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).

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.

• 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
• 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
  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.
  Intervention: Drug: Glucose 25% oral solution
• 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.
  Intervention: Other: Oral water
• 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.
  Intervention: Drug: Glucose 25% oral solution
• 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.
  Intervention: Other: Oral water

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.