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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Oral water with soother and tucking | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete a standard ECHO | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's & Women's Health Centre of BC | Vancouver | British Columbia | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26496361 | Derived | 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. |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D012996 | Solutions |
| D014867 | Water |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D004364 |
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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.
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| 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. |
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| 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 |
| Pharmaceutical Preparations |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |