Breast Feeding Analgesia in Preterm Infants

University of British Columbia50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pain

Interventions

Blood collectionPROCEDURE

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.

Blood collectionPROCEDURE

For the feeding condition, infants will be held and then breast fed by their mother during the blood collection.

Eligibility

Sex: ALLMin age: 3 DaysMax age: 37 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

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

Outcomes

Primary Outcomes

Videotaped and recorded at Baseline, Lance and Recovery:

Behavioral Indicators of Infant Pain (BIIP) - total score

Heart Rate

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

Data from ClinicalTrials.gov

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