Clinical Trial Details
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NCT03272594 : The Influence of Breastfeeding on Cortical Activity During Procedures
PhasePhase 3
AgesMin: N/A Max: 72 Hours
Inclusion Criteria:

- Healthy, full term, normally breastfeeding infants, whose mother is willing to
breastfeed during the painful procedure and consents to study participation. Normally
breastfeeding infants will be defined as those infants who had fed directly at the
breast a minimum of two times in the 24-hours prior to blood collection and whose
mother and/or staff nurse reported active sucking and swallowing during those feeds.
Infants who have undergone repeated heel lancing for blood glucose and/or bilirubin
monitoring (e.g., small or large for gestational age infants, infants born to diabetic
mothers, or with hyperbilirubinemia) will be considered eligible, however, diagnosis
and the number of prior painful procedures will be recorded and retained for
statistical analysis.

Exclusion Criteria:

- Infants will not be eligible for study participation if they are a twin birth
(including all classifications of monozygotic and dizygotic twins) due to the
potential for non-independence of outcomes between twin pairs, show signs of
infection, significant lower limb tissue damage, have had previous surgery or
intra-ventricular hemorrhage, are born to opioid using mothers or with significant
genetic disorders, are unable to breastfeed or have contraindications to sucrose
administration, or whose parents are unable to provide written informed consent.
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