Skip to main content
Clinical Trials/NCT00175409
NCT00175409
Completed
Phase 1

Breast Feeding Analgesia in Preterm Infants

University of British Columbia2 sites in 1 country50 target enrollmentJanuary 2008
ConditionsPain

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Pain
Sponsor
University of British Columbia
Enrollment
50
Locations
2
Primary Endpoint
Behavioral Indicators of Infant Pain (BIIP) - total score
Status
Completed
Last Updated
15 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
June 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Behavioral Indicators of Infant Pain (BIIP) - total score

Heart Rate

Videotaped and recorded at Baseline, Lance and Recovery:

Secondary Outcomes

  • 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

Study Sites (2)

Loading locations...

Similar Trials