Breast Feeding Analgesia in Preterm Infants - Full Text View

Sponsor:	University of British Columbia
Collaborator:	SickKids Foundation
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175409

Purpose

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:

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

Condition	Intervention	Phase
Pain	Procedure: Blood collection	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Breast Feeding Analgesia in Preterm Infants

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding Premature Babies

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Videotaped and recorded at Baseline, Lance and Recovery: [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Behavioral Indicators of Infant Pain (BIIP) - total score [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Heart Rate [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Videotaped and Recorded at Baseline, Lance and Recovery: [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Hand Movements [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Sleep/Wake States [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Samples taken at baseline, lance and recovery [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Salivary Cortisol sample [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Recorded before the breast feeding intervention and at 24 hours following: [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Preterm Infant Breastfeeding Behavior Scale [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2008
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	up to 37 Weeks
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Dr. Liisa Holsti, University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175409 History of Changes
Other Study ID Numbers:	C05-0248
Study First Received:	September 11, 2005
Last Updated:	April 11, 2011
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Pain Response

ClinicalTrials.gov processed this record on February 12, 2012