Pain
Conditions
Keywords
Pain Response
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.
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.
Interventions
PROCEDUREBlood 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.
Sponsors
SickKids Foundation
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Days to 37 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Videotaped and recorded at Baseline, Lance and Recovery: | — |
| Behavioral Indicators of Infant Pain (BIIP) - total score | — |
| Heart Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Samples taken at baseline, lance and recovery | — |
| Salivary Cortisol sample | — |
| Videotaped and Recorded at Baseline, Lance and Recovery: | — |
| Preterm Infant Breastfeeding Behavior Scale | — |
| Recorded before the breast feeding intervention and at 24 hours following: | — |
| Hand Movements | — |
| Sleep/Wake States | — |
Countries
Canada
Outcome results
None listed