An interventional study of breastfeeding in Pain, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 3 Days and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-14.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
The purpose of this study is to compare the effects of mothers' skin-to-skin holding during feeding via a soother trainer with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure
Hypothesis:
Research Method:
In a between subjects, randomized design, 20 stable preterm infants born between 30-35 weeks gestational age will be studied. Infants will be randomized to one of two interventions which will take place during 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 holding condition, infants will be held skin-to-skin by their mothers and given breast milk using a soother trainer during the blood collection.
University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
See detailed description.
Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate
Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States
Samples taken at baseline and recovery;Salivary Cortisol sample
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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University of British Columbia