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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT00971958
Eligibility Criteria:
Inclusion Criteria:
* Mothers (and fathers) of liveborn male infants at one of the four study sites who are \> 21 years of age (mothers less than 21 years of age, age of majority in Botswana, will provide assent, and will need consent from a guardian to allow participation of mother and infant in this study).
* Fathers of liveborn male infants at one of the four study sites who are \> 21 years of age
* Ability to follow up regularly at study clinic until 4 months postpartum
* Provision of written informed consent
Exclusion Criteria:
* Neonatal sepsis or other severe illness requiring infant hospitalization
* Penile abnormality that might require reconstructive surgery in the future (penile torsion / median raphe not midline, hypospadias / blind urethral pit, buried penis, penile-scrotal web, hydrocoele, dorsal hood / ventral foreskin missing, lack of scrotal ruggae suggesting lack of testicles bilaterally as could be karyotypic XX, megameatus or any other abnormality that may require consultation with urologist)
* Family history of bleeding disorder
* Estimated infant gestational age \< 37 weeks
* Infant delivery weight \< 2,500 grams
* Infant \> 4 weeks of age
* Infant receipt of methaemoglobin-inducing agents
* Current involuntary incarceration of mother
Healthy Volunteers:
True
Sex:
MALE
Maximum Age:
28 Days
Study:
NCT00971958
Study Brief:
Protocol Section:
NCT00971958