Pain Clinical Trial
Official title:
The Holding Pilot 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
Hypothesis:
1. When held by their mothers during blood collection, preterm infants will show less pain
reaction than when sucking on a pacifier.
2. Following holding during the blood collection, mothers will find no differences in
their infants' feeding ability.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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