Breast Feeding Analgesia in Preterm Infants
1 other identifier
interventional
50
1 country
2
Brief Summary
The purpose of this study is to compare the effects of mothers' breastfeeding with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure Hypothesis:
- 1.When breast fed by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
- 2.Following breast feeding during the blood collection, mothers will find no differences in their infants' breast feeding ability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 pain
Started Jan 2008
Longer than P75 for phase_1 pain
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedApril 12, 2011
April 1, 2011
2.4 years
September 11, 2005
April 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Videotaped and recorded at Baseline, Lance and Recovery:
Behavioral Indicators of Infant Pain (BIIP) - total score
Heart Rate
Secondary Outcomes (7)
Videotaped and Recorded at Baseline, Lance and Recovery:
Hand Movements
Sleep/Wake States
Samples taken at baseline, lance and recovery
Salivary Cortisol sample
- +2 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORInfants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection.
2
ACTIVE COMPARATORInfants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
Interventions
For the standard care condition, infants will remain in their isolettes and will be positioned in prone and given a pacifier to suck on throughout the blood collection.
Eligibility Criteria
You may qualify if:
- born between 30-36 weeks gestational age
- breastfeeding
- mother has fluent English
You may not qualify if:
- CNS injury
- congenital anomaly
- active infection
- has had surgeries or analgesics/sedatives in last 72 hours
- history of maternal drug exposure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- SickKids Foundationcollaborator
Study Sites (2)
Lions Gate Hospital - Special Care Nursery
North Vancouver, British Columbia, Canada
Children's and Women's Health Centre of British Columbia - Neonatal Intensive Care Unit & Intermediate Care Nursery
Vancouver, British Columbia, V6H 3V4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liisa Holsti, PhD, OT
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 11, 2005
First Posted
September 15, 2005
Study Start
January 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
April 12, 2011
Record last verified: 2011-04