Status:
COMPLETED
The Influence of Breastfeeding on Cortical Activity During Procedures
Lead Sponsor:
Britney Benoit
Collaborating Sponsors:
Dalhousie University
IWK Health Centre
Conditions:
Pain
Neonatal
Eligibility:
All Genders
Up to 72 years
Phase:
PHASE3
Brief Summary
Background: Even the healthiest infants undergo painful procedures as part of universal medical care. Untreated early pain is associated with heightened pain response during later procedures in infanc...
Eligibility Criteria
Inclusion
- Healthy, full term, normally breastfeeding infants, whose mother is willing to breastfeed during the painful procedure and consents to study participation. Normally breastfeeding infants will be defined as those infants who had fed directly at the breast a minimum of two times in the 24-hours prior to blood collection and whose mother and/or staff nurse reported active sucking and swallowing during those feeds. Infants who have undergone repeated heel lancing for blood glucose and/or bilirubin monitoring (e.g., small or large for gestational age infants, infants born to diabetic mothers, or with hyperbilirubinemia) will be considered eligible, however, diagnosis and the number of prior painful procedures will be recorded and retained for statistical analysis.
Exclusion
- Infants will not be eligible for study participation if they are a twin birth (including all classifications of monozygotic and dizygotic twins) due to the potential for non-independence of outcomes between twin pairs, show signs of infection, significant lower limb tissue damage, have had previous surgery or intra-ventricular hemorrhage, are born to opioid using mothers or with significant genetic disorders, are unable to breastfeed or have contraindications to sucrose administration, or whose parents are unable to provide written informed consent.
Key Trial Info
Start Date :
November 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2019
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03272594
Start Date
November 29 2017
End Date
January 29 2019
Last Update
November 8 2019
Active Locations (1)
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1
Britney Benoit
Halifax, Nova Scotia, Canada, B3K6R8