Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 126167 | Other Grant/Funding Number | Canadian Institutes of Health Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
| IWK Health Centre | OTHER |
| The Ottawa Hospital | OTHER |
| Children's Hospital of Eastern Ontario |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures, such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for reducing babies' pain during painful procedures. Unfortunately, sucrose is not used as often as it could be to reduce babies' pain. This may be due to lack of certainty about the least effective amount of sucrose to use and concerns about the long-term effects of repeated use of sucrose on infant development. Factors within the hospital units where babies receive care may also influence caregivers' decisions to use sucrose. In this research the investigators will conduct two main studies. In the first study the investigators determined the lowest amount of sucrose needed to manage babies' pain effectively. In the second study the investigators will explore (a) if this amount of sucrose can manage pain when it is used repeatedly for all painful procedures while the baby is hospitalized and (b) whether consistent use of sucrose influences the development of babies when they are 18 and 36 months old. During the second study, the investigators will also examine the hospital units where the babies receive care. They will look at staff support for research, time and resources and other factors that promote and prevent sucrose use. The results of these studies will be used to determine the best management of babies' pain during painful procedures in hospitals to achieve the best outcomes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sucrose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24% Sucrose Solution | Other | Two minutes prior to the start of a painful procedure neonates will receive 0.12ml of 24% sucrose solution, over a period of no more than 1 minute. A pacifier will be offered immediately following sucrose administration for non-nutritive sucking if the infant is able to hold the pacifier securely. The sucrose study dose is to be repeated as needed based on pain response and procedure duration. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Assessed by the Premature Infant Pain Profile - Revised (PIPP-R) | Measured 30 seconds post-painful procedure. (NB: Enrolled infants may be evaluated for multiple painful procedures.) |
| Pain intensity | Assessed by the Premature Infant Pain Profile - Revised (PIPP-R) | Measured 60 seconds post-painful procedure. (NB: Enrolled infants may be evaluated for multiple painful procedures.) |
| Neurodevelopment (cognitive, language and motor development) | Assessed by the Bayley Scales of Infant and Toddler Development (BSITD-III) | 18 months corrected gestational age |
| Neurodevelopment (cognitive, language and motor development) | Assessed by the Bayley Scales of Infant and Toddler Development (BSITD-III) | 36 months corrected gestational age |
| Neurodevelopment (social-emotional functioning) | Assessed by the Ages & Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2) | 36 months corrected gestational age |
| Neurodevelopment (vision, hearing, speech, emotion, dexterity, self-care, cognition, pain, general health and behaviour) | Assessed by the Health Status Classification System-Preschool (HSCS-PS) | 36 months corrected gestational age |
Not provided
Not provided
Inclusion:
Exclusion:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bonnie Stevens, PhD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada | ||
| Children's Hospital of Eastern Ontario |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38986541 | Derived | Bueno M, Ballantyne M, Campbell-Yeo M, Estabrooks C, Gibbins S, Harrison D, McNair C, Riahi S, Squires J, Synnes AR, Taddio A, Victor C, Yamada J, Stevens B. Cumulative sucrose exposure for repeated procedural pain in preterm neonates and neurodevelopment at 18 months of corrected age: a prospective observational longitudinal study. BMJ Paediatr Open. 2024 Jul 10;8(1):e002604. doi: 10.1136/bmjpo-2024-002604. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ottawa |
| Ontario |
| K1H 8L1 |
| Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |