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Breast Feeding Analgesia in Preterm Infants

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ClinicalTrials.gov Identifier: NCT00175409
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 12, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Pain Procedure: Blood collection Phase 1

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Breast Feeding Analgesia in Preterm Infants
Study Start Date : January 2008
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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.
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.
Procedure: Blood collection
For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.


Outcome Measures

Primary Outcome Measures :
  1. Videotaped and recorded at Baseline, Lance and Recovery:
  2. Behavioral Indicators of Infant Pain (BIIP) - total score
  3. Heart Rate

Secondary Outcome Measures :
  1. Videotaped and Recorded at Baseline, Lance and Recovery:
  2. Hand Movements
  3. Sleep/Wake States
  4. Samples taken at baseline, lance and recovery
  5. Salivary Cortisol sample
  6. Recorded before the breast feeding intervention and at 24 hours following:
  7. Preterm Infant Breastfeeding Behavior Scale

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175409


Locations
Canada, British Columbia
Lions Gate Hospital - Special Care Nursery
North Vancouver, British Columbia, Canada
Children's and Women's Health Centre of British Columbia - Neonatal Intensive Care Unit & Intermediate Care Nursery
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
SickKids Foundation
Investigators
Principal Investigator: Liisa Holsti, PhD, OT University of British Columbia
More Information

Responsible Party: Dr. Liisa Holsti, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175409     History of Changes
Other Study ID Numbers: C05-0248
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 2011

Keywords provided by University of British Columbia:
Pain Response