The Influence of Breastfeeding on Cortical Activity During Procedures
Status:
Completed
Trial end date:
2019-01-29
Target enrollment:
Participant gender:
Summary
Background: Even the healthiest infants undergo painful procedures as part of universal
medical care. Untreated early pain is associated with heightened pain response during later
procedures in infancy and alteration in response to pain in childhood. Oral sucrose is
currently considered the standard of care for acute pain relief in infants. Compelling
evidence from 57 randomized controlled trials suggests that oral sucrose reduces
bio-behavioral pain response. However, recent data examining the influence of oral sucrose on
pain-specific brain activity measured using electroencephalogram (EEG) questions the efficacy
of this intervention for reducing pain in the infant brain. Evidence supports the
effectiveness of breastfeeding as a pain relieving intervention, however, no studies to date
have examined the effect of breastfeeding on pain-specific activity in the newborn brain.
Aims: The primary aim of this study is to examine the influence of breastfeeding in
comparison to oral sucrose on pain-specific activity in the newborn brain during a heel
lance. The secondary aim will be to determine if there is convergence among outcome measures
in either of the intervention conditions.
Methods: Utilizing a single blind, randomized controlled trial design, 126 healthy term
infants will be recruited within the first two days of life. Infants will be randomized to
have a medically indicated heel lance completed in one of two possible conditions: 1)
breastfeeding (n = 63) or 2) sucrose in an infant cot (n = 63). Infants will not be eligible
for study participation if they show signs of lower limb tissue damage, have had previous
surgery or intraventricular hemorrhage, are born to opioid using mothers or with significant
genetic disorders, are unable to breastfeed, or have contraindications to sucrose
administration. Pain-specific brain activity will be recorded on EEG for the duration of the
blood collection. Infant facial response will be video recorded, and heart rate and oxygen
saturation will be measured for calculation of Premature Infant Pain Profile-Revised (PIPP-R)
Score, a reliable and valid bio-behavioral measure of pain in infants' 26-44 weeks
gestational age. For infants randomized to the breastfeeding condition, data collection will
begin with recording of a one-minute baseline (BL1). Following this, a non-painful control
stimulus will be applied to the infant's foot to capture a baseline response on EEG to a
non-painful event. The infant will then be transferred to the mother and active breastfeeding
will be facilitated. A second baseline (BL2) will be recorded prior to heel lance. Pain
response will be recorded from the initiation of the heel lance until procedure completion.
In the sucrose condition, all monitoring will take place while the infant is in a cot
(considered standard of care). Procedures will be consistent with those outlined above with
the exception of administration of 24% oral sucrose two minutes prior to the heel lance.
Analysis and inference will be calculated based on the intention-to-treat principle. Data
from the EEG recording will be grouped into basic waveforms using principal component
analysis. Two one-way analysis of variances will be used to assess the effect of stimulation
type (non-painful control, painful heel lance) and treatment (24% oral sucrose,
breastfeeding) on the principal components. To assess for the effect of treatment on PIPP-R
score, group means will be compared using unpaired Student's t-tests.
Hypotheses: Infants in the breastfeeding condition will demonstrate both lower pain-specific
brain response and lower bio-behavioral pain scores than infants in the sucrose condition.
Significance: This will be the first study to examine the effect of breastfeeding on
pain-specific brain response in infants. In light of the negative consequences of unmanaged
pain in infants, it is imperative that effective pain relieving interventions are utilized.
Given recent evidence questioning the analgesic properties of sucrose, findings will have
important implications for informing optimal pain management practices in infants.