Early infant male circumcision using devices

Not Applicable

• Conditions: HIV/AIDS; Surgery; Urological and Genital Diseases; Paediatrics; Early infant circumcision ultimately for HIV prevention

• Registration Number: PACTR201301000465398
• Lead Sponsor: Bill and Melinda Gates Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-27
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

Live born male infants at study sites aged 7-10 days.
Ability to follow-up regularly at study clinic until 2 weeks postpartum
Mother prepared to provide locator information and to be visited home between delivery and circumcision
Mother prepared to provide verifiable cell phone (mobile) number
Provision of written informed consent
Baby should have received vitamin K (routine or offered by study staff)

Exclusion Criteria

Neonatal sepsis or other severe illness requiring infant hospitalization
Penile abnormality that might require reconstructive surgery in the future
Family history of bleeding disorder
Estimated infant gestational age < 36 weeks (we envisage that this information would be sufficiently and accurately recorded on the child health card by clinic staff)
Infant delivery weight < 2,500 grams (we envisage that this information would be sufficiently and accurately recorded on the child health card by clinic staff)
Infant >10 days of age
Infant receipt of methaemoglobin-inducing agents
Current involuntary incarceration of mother

Study & Design

• Study Type: Interventional
• Study Design: Not specified