Sucrose Practices for Pain in Neonates Part B

NCT02725814 | Completed DMC

• 2 other identifiers: REB1000051066126167
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 5

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.

Conditions

Pain

Keywords

Sucrose; Effectiveness; Healthcare Delivery; Neonates; Nursing

Outcome Measures

Primary Outcomes (6)

• Pain intensity

  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

  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)

  Assessed by the Bayley Scales of Infant and Toddler Development (BSITD-III)

  18 months corrected gestational age

• Neurodevelopment (cognitive, language and motor development)

  Assessed by the Bayley Scales of Infant and Toddler Development (BSITD-III)

  36 months corrected gestational age

• Neurodevelopment (social-emotional functioning)

  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)

  Assessed by the Health Status Classification System-Preschool (HSCS-PS)

  36 months corrected gestational age

Study Arms (1)

Sucrose

EXPERIMENTAL

Other: 24% Sucrose Solution

Interventions

24% Sucrose Solution OTHER

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.

Sucrose

Eligibility Criteria

• Age: Up to 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Sunnybrook Health Sciences Centre: collaborator
• IWK Health Centre: collaborator
• The Ottawa Hospital: collaborator
• Children's Hospital of Eastern Ontario: collaborator

Study Sites (5)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 38986541 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bonnie Stevens, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Nursing Research, Senior Scientist

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: April 1, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)