Sucrose Practices for Pain in Neonates Part B

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: 24% Sucrose Solution

• Registration Number: NCT02725814
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-28
• Study First Posted: 2016-04-01
• Primary Completion: 2022-04
• Study Completion: 2022-04
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-05
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sucrose	24% Sucrose Solution	-

Primary Outcome Measures

Name	Time	Method
Neurodevelopment (vision, hearing, speech, emotion, dexterity, self-care, cognition, pain, general health and behaviour)	36 months corrected gestational age	Assessed by the Health Status Classification System-Preschool (HSCS-PS)
Pain intensity	Measured 60 seconds post-painful procedure. (NB: Enrolled infants may be evaluated for multiple painful procedures.)	Assessed by the Premature Infant Pain Profile - Revised (PIPP-R)
Neurodevelopment (cognitive, language and motor development)	36 months corrected gestational age	Assessed by the Bayley Scales of Infant and Toddler Development (BSITD-III)
Neurodevelopment (social-emotional functioning)	36 months corrected gestational age	Assessed by the Ages \& Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2)

Trial Locations

Locations (5)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada