Neonatal Male Circumcision
Conditions
Keywords
neonatal male circumcision, Clinical officers vs Nurse midwives, Rakai, Uganda, acceptability and safety of neonatal male circumcision
Brief summary
Background: Medical male circumcision (MMC) for HIV prevention is a priority in 14 East and Southern African countries, and the long-term sustainability of MMC programs could best be achieved by early infant male circumcision (EIMC.) However, the acceptability and safety of EIMC provided by non-physicians is unknown. Methods: We conducted a trial of EIMC using the Mogen clamp provided by newly trained clinical officers (CO) and nurse midwives (NMWs) in 4 health centers in rural Rakai, Uganda. 501 healthy neonates aged 1-28 days with normal birth weight and gestational age were randomized to CO (n=256) and NMWs (n=245), and were followed up at 24 hours, 7 and 28 days. Combined analgesia was provided by paracetamol suppository, Eutectic Mixture of Local Anesthetics (EMLA) cream and a 24% sucrose solution.
Detailed description
The objective was to assess the acceptability and safety of neonatal male circumcision performed by clinical officers (equivalent to US physician assistants) and nurse midwives, using the Mogen clamp. This was a randomized, blinded trial of circumcision using the Mogen clamp under topical anesthesia in healthy male infants aged 1-28 days, with normal birth weight and gestational age, performed by trained clinical officers or nurse midwives, randomized 1:1 in Rakai District, Uganda. Mothers of male infants born in 4 health centers were invited to participate and signed an informed consent for screening and enrollment. Infants were screened on enrollment prior to randomization (1;1) to clinical officer and nurse midwife circumcision providers. Follow up was via a phone call at 24 hours, 7 days and 4 weeks post-circumcision.
Interventions
The standard procedure for neonatal circumcision is as follows: combined analgesia was topical 2.5% lidocaine and 2.5% prilocaine \<1 gm applied 60 minutes and 40mg acetaminophen suppository 30 minutes prior to surgery. Infants were given a 24% sucrose solution pacifier if needed. Infants under 2 weeks of age received subcutaneous Vitamin K 1 mg. The perineum cleaned, and the penis swabbed with povidone iodine. Hemostats were applied at 3 and 9 o'clock positions and the glans pushed down. Traction was applied before placing the Mogen clamp, the clamp was closed for 5 minutes and the foreskin removed with a scalpel. Petroleum jelly (e.g., Vaseline) was applied to the glans and the wound covered with sterile gauze. Infants were observed for one hour. Mothers were instructed in wound care.
Sponsors
Study design
Eligibility
Inclusion criteria
* age 1-28 days * birth weight \>= 2,500 gm * gestational age \>=37 weeks * no illness. normal temperature * no genital anatomic abnormality
Exclusion criteria
* age \>28 days * birth weight \<2,500 gm * gestational age \<37 weeks * Ill health * genital abnormality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events related to circumcision | 4 weeks | Adverse events graded as mild, moderate and severe |
| Acceptability as measured by the proportion of mothers directly informed about the study who consented to enroll in the trial | through study completion, an of 1 year | Proportion of registered mother-child pairs in which the male infant was circumcised |
| Wound healing | 4 weeks | Completed wound healing (clean intact scar without a scab or stitch sinus) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | Less than 15 minutes | Length of time from preoperative prep to completion |
| Parental satisfaction | 4 weeks | Mother's report of satisfaction with the procedure |
| Neonatal pain scale (NIPS) | During surgery | based of facial expression, crying, breathing patterns, movement of arms and legs, and state of arousal. NIPS scores 0 were classified as no pain, scores 1-2 mild, scores 3-4 as moderate and \>4 as severe pain. |