Breast Feeding Analgesia in Preterm Infants

Phase 1

Completed

• Conditions: Pain
• Interventions: Procedure: Blood collection

• Registration Number: NCT00175409
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-15
• Study Start: 2008-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-11
• Last Update Posted: 2011-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Blood collection	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.
2	Blood collection	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.

Primary Outcome Measures

Name	Time	Method
Behavioral Indicators of Infant Pain (BIIP) - total score
Heart Rate
Videotaped and recorded at Baseline, Lance and Recovery:

Secondary Outcome Measures

Name	Time	Method
Videotaped and Recorded at Baseline, Lance and Recovery:
Hand Movements
Sleep/Wake States
Preterm Infant Breastfeeding Behavior Scale
Samples taken at baseline, lance and recovery
Salivary Cortisol sample
Recorded before the breast feeding intervention and at 24 hours following:

Trial Locations

Locations (2)

Children's and Women's Health Centre of British Columbia - Neonatal Intensive Care Unit & Intermediate Care Nursery; 🇨🇦 Vancouver, British Columbia, Canada

Lions Gate Hospital - Special Care Nursery; 🇨🇦 North Vancouver, British Columbia, Canada