Sucrose Practices for Pain in Neonates Part B (SPiN)

June 5, 2022 updated by: Bonnie Stevens, The Hospital for Sick Children

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sucrose
Other: 24% Sucrose Solution
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Measured 30 seconds post-painful procedure. (NB: Enrolled infants may be evaluated for multiple painful procedures.)
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
Time Frame: 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)
Measured 60 seconds post-painful procedure. (NB: Enrolled infants may be evaluated for multiple painful procedures.)
Neurodevelopment (cognitive, language and motor development)
Time Frame: 18 months corrected gestational age
Assessed by the Bayley Scales of Infant and Toddler Development (BSITD-III)
18 months corrected gestational age
Neurodevelopment (cognitive, language and motor development)
Time Frame: 36 months corrected gestational age
Assessed by the Bayley Scales of Infant and Toddler Development (BSITD-III)
36 months corrected gestational age
Neurodevelopment (social-emotional functioning)
Time Frame: 36 months corrected gestational age
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)
Time Frame: 36 months corrected gestational age
Assessed by the Health Status Classification System-Preschool (HSCS-PS)
36 months corrected gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Sunnybrook Health Sciences Centre
The Ottawa Hospital
Children's Hospital of Eastern Ontario
IWK Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ACTUAL)

April 1, 2022

Study Completion (ACTUAL)

April 1, 2022

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (ESTIMATE)

April 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 5, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REB1000051066
  • 126167 (OTHER_GRANT: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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