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 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT01800318
Eligibility Criteria:
Inclusion Criteria:
* Newborn infants born at 37-42 weeks gestational age
* Less than 3 days of age
* Requiring a heelstick for clinically indicated blood sampling
* Written, informed consent from their parents.
Exclusion Criteria:
* Newborns who have received any analgesic treatment
* Exposed to chronic opiates in utero (excluding opiates given only at the time of delivery) or with a positive drug screen based on review of medical records.
* Current maternal cigarette smoking.
* Infants exposed to birth asphyxia (5-minute Apgar scores of \<5 or cord pH \<7.0).
* Infants on mechanical ventilation.
* Newborns with suspected or confirmed neuromuscular diseases, congenital anomalies, or sepsis.
* Infants with birth trauma to the lower extremities (bruising or other) or those exposed multiple heelsticks in the previous 24 hours (e.g. requiring frequent glucose or bilirubin measurements).
* Infants born from mothers with drug addiction, diabetes, pre-eclampsia, or systemic inflammatory conditions.
* Abnormal neurological exam
* Congenital heart defects
* Enrollment or participation in other studies
* Dermatologic condition in the area of electrode placement or elsewhere
* Local or systemic infection documented or suspected
* Reasonable known allergy to the gel/adhesive
* Bleeding abnormality
* Connection to other medical equipment or devices that might interfere with the workings or functioning of the transcutaneous electrical nerve stimulation (TENS) unit
* Any condition the investigator determines will put the subject at risk if participating in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
3 Days
Study:
NCT01800318
Study Brief:
Protocol Section:
NCT01800318