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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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