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Clinical Trials/NCT00414258
NCT00414258
Completed
Not Applicable

The Holding Pilot Study: Feeding Analgesia in Preterm Infants

University of British Columbia1 site in 1 country15 target enrollmentSeptember 2006
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
University of British Columbia
Enrollment
15
Locations
1
Primary Endpoint
Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate
Status
Completed
Last Updated
15 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
December 2007
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Born between 30-35 weeks gestational age
  • Mother has fluent English

Exclusion Criteria

  • CNS injury
  • congenital anomaly
  • active infection
  • has had no surgeries or analgesics/sedatives in last 72 hours
  • history of maternal drug exposure

Outcomes

Primary Outcomes

Videotaped and recorded at Baseline, Lance and Recovery:Neonatal Facial Coding System - total facial score; Heart Rate

Secondary Outcomes

  • Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States
  • Samples taken at baseline and recovery;Salivary Cortisol sample

Study Sites (1)

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