Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2008-01-31
2010-06-30
Brief Summary
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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.
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Detailed Description
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In a within subjects, randomized, cross-over design, 50 stable preterm infants born between 30-36 weeks gestational age will be studied. Infants 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. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
Infants 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.
Blood collection
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
Infants 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.
Blood collection
For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
Interventions
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Blood collection
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.
Blood collection
For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
Eligibility Criteria
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Inclusion Criteria
* breastfeeding
* mother has fluent English
Exclusion Criteria
* congenital anomaly
* active infection
* has had surgeries or analgesics/sedatives in last 72 hours
* history of maternal drug exposure
3 Days
37 Weeks
ALL
Yes
Sponsors
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SickKids Foundation
OTHER
University of British Columbia
OTHER
Responsible Party
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University of British Columbia
Principal Investigators
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Liisa Holsti, PhD, OT
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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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, Canada
Countries
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Other Identifiers
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C05-0248
Identifier Type: -
Identifier Source: org_study_id
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