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Completed

NCT Number: NCT02725814

Sucrose Practices for Pain in Neonates Part B

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.

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Key information

Conditions

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

Age range

Up to 10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Centre, Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Neurodevelopment (social-emotional functioning)

    Time frame: 36 months corrected gestational age

    Assessed by the Ages & Stages Questionnaires: Social-Emotional, Second Edition (ASQ:SE-2)

  6. 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)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SPiN

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2016
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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