Clinical trial NCT02725814: Sucrose Practices for Pain in Neonates Part B
Official title: Sucrose Practices for Pain in Neonates Part B: Efficacy of Repeated Sucrose Administration, Infant Response to Administration, and Effect on Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Sucrose
Effectiveness
Healthcare Delivery
Neonates
Nursing
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: IWK Health Centre
name: The Ottawa Hospital
name: Children's Hospital of Eastern Ontario
First posted: 2016-04-01
Enrollment: 172
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Pain intensity
timeFrame: Measured 30 seconds post-painful procedure. (NB: Enrolled infants may be evaluated for multiple painful procedures.)
measure: Pain intensity
timeFrame: Measured 60 seconds post-painful procedure. (NB: Enrolled infants may be evaluated for multiple painful procedures.)
measure: Neurodevelopment (cognitive, language and motor development)
timeFrame: 18 months corrected gestational age
measure: Neurodevelopment (cognitive, language and motor development)
timeFrame: 36 months corrected gestational age
measure: Neurodevelopment (social-emotional functioning)
timeFrame: 36 months corrected gestational age
measure: Neurodevelopment (vision, hearing, speech, emotion, dexterity, self-care, cognition, pain, general health and behaviour)
timeFrame: 36 months corrected gestational age
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Bonnie Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References: