Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-02 @ 6:46 AM
Study NCT ID:
NCT00414258
Status:
COMPLETED
Last Update Posted:
2011-04-14
First Post:
2006-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Holding Study: Feeding Analgesia in Preterm Infants
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
The Holding Pilot Study: Feeding Analgesia in Preterm Infants
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: