Sucrose Practices for Pain in Neonates Part B

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Sucrose Practices for Pain in Neonates Part B: Efficacy of Repeated Sucrose Administration, Infant Response to Administration, and Effect on Outcomes

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: 24% Sucrose Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: less than 32 weeks gestational age at birth admitted to the neonatal intensive care unit (NICU) expected to have heel lances for routine blood tests yet to reach 10 days of life at the time of study enrollment. Exclusion: known hypersensitivity to sucrose, corn, corn products or any component of the formulation short-bowel syndrome carbohydrate intolerance unable to swallow/absent gag reflex (e.g., pharmacologically muscle relaxed, unconscious, or heavily sedated)

Ages Eligible for Study
-----------------
Maximum Age: 10 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sucrose<br> | Other: 24% Sucrose Solution<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sucrose, Effectiveness, Healthcare Delivery, Neonates, Nursing