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Breast Feeding Analgesia in Preterm Infants

This study is currently recruiting participants.

Study NCT00175409. Last updated on July 14, 2008. Information provided by University of British Columbia

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Breast Feeding Analgesia in Preterm Infants

Official Title ^†

Breast Feeding Analgesia in Preterm Infants

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:

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.

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 Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

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 Measure ^†

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 ]

Condition ^†

Pain

Intervention ^†

Procedure: Blood collection

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

January 2008

Completion Date

December 2009

Eligibility 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

Gender

Both

Ages

up to 37 Weeks

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Colleen Jantzen, BA

604-875-2000 ext 5995

cjantzen@cw.bc.ca

Location Countries ^†

Canada

Administrative Information Fields

NCT ID ^†

NCT00175409

Organization ID

C05-0248

Secondary IDs ^††

Study Sponsor ^†

University of British Columbia

Collaborators ^††

SickKids Foundation

Investigators ^†

Principal Investigator:

Liisa Holsti, PhD, OT

University of British Columbia

Information Provided By

University of British Columbia

Verification Date

July 2008

First Received Date ^†

September 11, 2005

Last Updated Date

July 14, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.