PainSPiNNCT02725814
Sucrose Practices for Pain in Neonates Part B
A study testing 24% Sucrose Solution in people with Pain, run by The Hospital for Sick Children at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 10 days
- Conditions the study is for
- Pain
- What is being tested?
- 24% Sucrose Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 5 sitesCanada
- Study dates
- Mar 2016to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: 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.
- Conditions
- Pain
- Being tested
- 24% Sucrose Solution
- Keywords
- Sucrose, Effectiveness, Healthcare Delivery, Neonates, Nursing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24% Sucrose SolutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Experimental | Not described Receives: Other: 24% Sucrose Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Assessed by the Premature Infant Pain Profile - Revised (PIPP-R)
Measured: 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: 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)
Measured: 18 months corrected gestational age
Neurodevelopment (cognitive, language and motor development)
Assessed by the Bayley Scales of Infant and Toddler Development (BSITD-III)
Measured: 36 months corrected gestational age
Neurodevelopment (social-emotional functioning)
Assessed by the Ages \& Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2)
Measured: 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)
Measured: 36 months corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2022
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, IWK Health Centre, The Ottawa Hospital, Children's Hospital of Eastern Ontario
- Responsible party
- Principal investigator, Bonnie Stevens, The Hospital for Sick Children
- Investigators
- Bonnie Stevens, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725814
- Sponsor's protocol ID
- REB1000051066
- Other IDs
- 126167
- Acronym
- SPiN
- Status last verified
- Jun 2022
- First submitted
- 9 Mar 2016
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bueno M, Ballantyne M, Campbell-Yeo M, Estabrooks C, Gibbins S, Harrison D, McNair C, Riahi S, Squires J, Synnes AR, Taddio A, Victor C, Yamada J, Stevens B. Cumulative sucrose exposure for repeated procedural pain in preterm neonates and neurodevelopment at 18 months of corrected age: a prospective observational longitudinal study. BMJ Paediatr Open. 2024 Jul 10;8(1):e002604. doi: 10.1136/bmjpo-2024-002604.
PubMed 38986541
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sucrose Practices for Pain in Neonates Part B: Efficacy of Repeated Sucrose Administration, Infant Response to Administration, and Effect on Outcomes
- ClinicalTrials.gov ID
- NCT02725814
- Acronym / sponsor ID
- SPiN / REB1000051066
- Conditions
- Pain
- Keywords
- Sucrose, Effectiveness, Healthcare Delivery, Neonates, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, IWK Health Centre, The Ottawa Hospital, Children's Hospital of Eastern Ontario
- Study start
- Mar 2016
- Primary completion
- Apr 2022 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Experimental | Other: 24% Sucrose Solution |
Who may qualify
- Ages
- Up to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24% Sucrose SolutionTwo 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. | Other | Sucrose |
Primary outcome
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)
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)
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)
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)
Neurodevelopment (social-emotional functioning)
Time frame: 36 months corrected gestational age
Assessed by the Ages \& Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Derived from this study: PubMed 38986541Bueno M, Ballantyne M, Campbell-Yeo M, Estabrooks C, Gibbins S, Harrison D, McNair C, Riahi S, Squires J, Synnes AR, Taddio A, Victor C, Yamada J, Stevens B. Cumulative sucrose exposure for repeated procedural pain in preterm neonates and neurodevelopment at 18 months of corrected age: a prospective observational longitudinal study. BMJ Paediatr Open. 2024 Jul 10;8(1):e002604. doi: 10.1136/bmjpo-2024-002604.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Stevens, PhD principal investigator
The Hospital for Sick Children
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24% Sucrose Solution in people with Pain, run by The Hospital for Sick Children at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Measured 30 seconds post-painful procedure. (NB: Enrolled infants may be evaluated for multiple painful procedures.)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.