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Breast Feeding Analgesia in Preterm Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00175409
First Posted: September 15, 2005
Last Update Posted: April 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
SickKids Foundation
Information provided by:
University of British Columbia
September 11, 2005
September 15, 2005
April 12, 2011
January 2008
June 2010   (Final data collection date for primary outcome measure)
  • Videotaped and recorded at Baseline, Lance and Recovery:
  • Behavioral Indicators of Infant Pain (BIIP) - total score
  • Heart Rate
  • Videotaped and recorded at Baseline, Lance and Recovery:
  • 1. Neonatal Facial Coding System – total facial score
  • 2. Heart Rate
Complete list of historical versions of study NCT00175409 on ClinicalTrials.gov Archive Site
  • Videotaped and Recorded at Baseline, Lance and Recovery:
  • Hand Movements
  • Sleep/Wake States
  • Samples taken at baseline, lance and recovery
  • Salivary Cortisol sample
  • Recorded before the breast feeding intervention and at 24 hours following:
  • Preterm Infant Breastfeeding Behavior Scale
  • Videotaped and Recorded at Baseline, Lance and Recovery:
  • 1. Hand Movements
  • 2. Sleep/Wake States
  • 3. Oxygen Saturation
  • Samples taken at baseline and recovery:
  • 1. Salivary Cortisol sample
  • Recorded before the breast feeding intervention and at 24 hours following:
  • 1. Preterm Infant Breastfeeding Behavior Scale
Not Provided
Not Provided
 
Breast Feeding Analgesia in Preterm Infants
Breast Feeding Analgesia in Preterm Infants

The purpose of this study is to compare the effects of mothers' breastfeeding with the effects of pacifier sucking on preterm infant biobehavioural responses during and immediately after a painful procedure

Hypothesis:

  1. When breast fed by their mothers during blood collection, preterm infants will show less pain reaction than when sucking on a pacifier.
  2. Following breast feeding during the blood collection, mothers will find no differences in their infants' breast feeding ability.

Research Method:

In a within subjects, randomized, cross-over design, 50 stable preterm infants born between 30-36 weeks gestational age will be studied. Infants will be randomized to two interventions which will take place during two separate 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 feeding condition, infants will be held and then breast fed by their mother during the blood collection.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pain
  • Procedure: Blood collection
    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.
  • Procedure: Blood collection
    For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
  • Active Comparator: 1
    Infants will be randomized to two interventions which will take place during two separate 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.
    Intervention: Procedure: Blood collection
  • Active Comparator: 2
    Infants will be randomized to two interventions which will take place during two separate blood collections that are required for clinical management. For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.
    Intervention: Procedure: Blood collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • born between 30-36 weeks gestational age
  • breastfeeding
  • mother has fluent English

Exclusion Criteria:

  • CNS injury
  • congenital anomaly
  • active infection
  • has had surgeries or analgesics/sedatives in last 72 hours
  • history of maternal drug exposure
Sexes Eligible for Study: All
up to 37 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00175409
C05-0248
No
Not Provided
Not Provided
Dr. Liisa Holsti, University of British Columbia
University of British Columbia
SickKids Foundation
Principal Investigator: Liisa Holsti, PhD, OT University of British Columbia
University of British Columbia
April 2011

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