- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00175409
Breast Feeding Analgesia in Preterm Infants
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:
- When breast fed by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
- Following breast feeding during the blood collection, mothers will find no differences in their infants' breast feeding ability.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research Method:
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
British Columbia
-
North Vancouver, British Columbia, Canada
- Lions Gate Hospital - Special Care Nursery
-
Vancouver, British Columbia, Canada, V6H 3V4
- Children's and Women's Health Centre of British Columbia - Neonatal Intensive Care Unit & Intermediate Care Nursery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- born between 30-36 weeks gestational age
- breastfeeding
- mother has fluent English
Exclusion Criteria:
- CNS injury
- congenital anomaly
- active infection
- has had surgeries or analgesics/sedatives in last 72 hours
- history of maternal drug exposure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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.
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Videotaped and recorded at Baseline, Lance and Recovery:
|
Behavioral Indicators of Infant Pain (BIIP) - total score
|
Heart Rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Videotaped and Recorded at Baseline, Lance and Recovery:
|
Hand Movements
|
Sleep/Wake States
|
Samples taken at baseline, lance and recovery
|
Salivary Cortisol sample
|
Recorded before the breast feeding intervention and at 24 hours following:
|
Preterm Infant Breastfeeding Behavior Scale
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Liisa Holsti, PhD, OT, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- C05-0248
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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