Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03272594
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
72 Hours
Study:
NCT03272594
Study Brief:
Protocol Section:
NCT03272594