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| Name | Class |
|---|---|
| SickKids Foundation | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 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. |
|
| 2 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Videotaped and recorded at Baseline, Lance and Recovery: | ||
| Behavioral Indicators of Infant Pain (BIIP) - total score | ||
| Heart Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Videotaped and Recorded at Baseline, Lance and Recovery: | ||
| Hand Movements | ||
| Sleep/Wake States |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liisa Holsti, PhD, OT | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Blood collection | Procedure | For the feeding condition, infants will be held and then breast fed by their mother during the blood collection. |
|
| 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 |
| Vancouver |
| British Columbia |
| V6H 3V4 |
| Canada |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |