The Holding Study: Feeding Analgesia in Preterm Infants
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
- When held by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
- Following holding during the blood collection, mothers will find no differences in their infants' feeding ability.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Holding Pilot Study: Feeding Analgesia in Preterm Infants|
- Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Samples taken at baseline and recovery;Salivary Cortisol sample [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414258
|Canada, British Columbia|
|Children's and Women's Health Centre of British Columbia, Special Care Nursery|
|Vancouver, British Columbia, Canada, V6H 3V4|
|Principal Investigator:||Liisa Holsti, Ph.D||University of British Columbia|