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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT00850993
Eligibility Criteria:
Inclusion Criteria:
Babies may only participate if they meet all the following criteria:
* Is a term or late preterm baby
* Is at risk for protocol-defined hemolytic disease
* Weighs at least 2500 g (5.5 lbs)
* Has total serum bilirubin (TSB) a specified amount lower than the phototherapy threshold for the age
* Has parents/guardians who are willing to follow light precautions and sign informed consent
Exclusion Criteria:
The following criteria will make a baby not eligible to participate:
* Needs medications that may prolong the QT interval
* Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome, or Porphyrias
* Has an Apgar score of 6 or below at age 5 minutes
* Has abnormalities or infections (in mother or child) that per protocol or in the opinion of the investigator may compromise the safety and well-being of the baby or analysis of study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Minute
Maximum Age:
48 Hours
Study:
NCT00850993
Study Brief:
Protocol Section:
NCT00850993