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The Holding Study: Feeding Analgesia in Preterm Infants
This study is currently recruiting participants.
Study NCT00414258   Information provided by University of British Columbia
First Received: December 19, 2006   Last Updated: September 24, 2008   History of Changes

December 19, 2006
September 24, 2008
September 2006
December 2008   (final data collection date for primary outcome measure)
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:Neonatal Facial Coding System – total facial score; Heart Rate
Complete list of historical versions of study NCT00414258 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Videotaped and Recorded at Baseline, Lance and Recovery:Hand Movements; Sleep/Wake States
  • Samples taken at baseline and recovery;Salivary Cortisol sample
 
The Holding Study: Feeding Analgesia in Preterm Infants
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.

 
Interventional
Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Pain
Procedure: breastfeeding
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
 
Yes
Contact: Colleen Jantzen 604-875-2000 ext 5995 cjantzen@cw.bc.ca
Canada
 
NCT00414258
Dr. Liisa Holsti, University of British Columbia
C06 - 0347
University of British Columbia
 
Principal Investigator: Liisa Holsti, Ph.D University of British Columbia
University of British Columbia
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP