Neonatal Male CircumcisionPhase 2/3NCT02596282
Enhanced Provision of Male Circumcision (MC) for HIV Prevention, Rakai, Uganda
A Phase 2/3 study testing Neonatal circumcision under topical anesthesia in people with Neonatal Male Circumcision, run by Johns Hopkins Bloomberg School of Public Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Male Circumcision
- What is being tested?
- Neonatal circumcision under topical anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Jul 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- age 1-28 days
- birth weight >= 2,500 gm
- gestational age >=37 weeks
- no illness. normal temperature
- no genital anatomic abnormality
Who cannot join
- age >28 days
- birth weight <2,500 gm
- gestational age <37 weeks
- Ill health
- genital abnormality
About this study
Official title: A Randomized Trial of the Acceptability and Safety of Early Infant Male Circumcision (EIMC) Conducted by Nurse Midwives and Clinical Offices Using the Mogen Clamp
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.
Read the 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.
- Conditions
- Neonatal Male Circumcision
- Being tested
- Neonatal circumcision under topical anesthesia
- Keywords
- neonatal male circumcision, Clinical officers vs Nurse midwives, Rakai, Uganda, acceptability and safety of neonatal male circumcision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal circumcision under topical anesthesiaProcedure or surgery
Also called Mogen clamp, Pre-operative analgesia
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Officer (CO), | Active comparator | COs were trained and provided neonatal male circumcision under topical anesthesia using the Mogen clamp Receives: Procedure: Neonatal circumcision under topical anesthesia |
| Nurse Midwife (NMW) | Experimental | NMWs were trained and provided neonatal male circumcision under topical anesthesia using the Mogen clamp Receives: Procedure: Neonatal circumcision under topical anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events related to circumcision
Adverse events graded as mild, moderate and severe
Measured: 4 weeks
Acceptability as measured by the proportion of mothers directly informed about the study who consented to enroll in the trial
Proportion of registered mother-child pairs in which the male infant was circumcised
Measured: through study completion, an of 1 year
Wound healing
Completed wound healing (clean intact scar without a scab or stitch sinus)
Measured: 4 weeks
Secondary outcomes (3)
Procedure time
Length of time from preoperative prep to completion
Measured: Less than 15 minutes
Parental satisfaction
Mother's report of satisfaction with the procedure
Measured: 4 weeks
Neonatal pain scale (NIPS)
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.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Male CircumcisionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Rakai Health Sciences Program, MRC/UVRI and LSHTM Uganda Research Unit
- Responsible party
- Principal investigator, Ronald Gray, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Ronald H Gray, MD MSc, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596282
- Sponsor's protocol ID
- 00004524
- Status last verified
- Nov 2015
- First submitted
- 23 Oct 2015
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kankaka EN, Murungi T, Kigozi G, Makumbi F, Nabukalu D, Watya S, Kighoma N, Nampijja R, Kayiwa D, Nalugoda F, Serwadda D, Wawer M, Gray RH. Randomised trial of early infant circumcision performed by clinical officers and registered nurse midwives using the Mogen clamp in Rakai, Uganda. BJU Int. 2017 Jan;119(1):164-170. doi: 10.1111/bju.13589. Epub 2016 Sep 6.
PubMed 27597563
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Acceptability and Safety of Early Infant Male Circumcision (EIMC) Conducted by Nurse Midwives and Clinical Offices Using the Mogen Clamp
- ClinicalTrials.gov ID
- NCT02596282
- Acronym / sponsor ID
- 00004524
- Conditions
- Neonatal Male Circumcision
- Keywords
- neonatal male circumcision, Clinical officers vs Nurse midwives, Rakai, Uganda, acceptability and safety of neonatal male circumcision
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Rakai Health Sciences Program, MRC/UVRI and LSHTM Uganda Research Unit
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Officer (CO), | Active comparator | Procedure: Neonatal circumcision under topical anesthesiaCOs were trained and provided neonatal male circumcision under topical anesthesia using the Mogen clamp |
| Nurse Midwife (NMW) | Experimental | Procedure: Neonatal circumcision under topical anesthesiaNMWs were trained and provided neonatal male circumcision under topical anesthesia using the Mogen clamp |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age 1-28 days
- birth weight >= 2,500 gm
- gestational age >=37 weeks
- no illness. normal temperature
- no genital anatomic abnormality
Key exclusion criteria (5 listed)
- age >28 days
- birth weight <2,500 gm
- gestational age <37 weeks
- Ill health
- genital abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neonatal circumcision under topical anesthesiaAlso: Mogen clamp, Pre-operative analgesiaThe 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. | Procedure or surgery | Clinical Officer (CO),, Nurse Midwife (NMW) |
Primary outcome
Adverse events related to circumcision
Time frame: 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
Time frame: through study completion, an of 1 year
Proportion of registered mother-child pairs in which the male infant was circumcised
Wound healing
Time frame: 4 weeks
Completed wound healing (clean intact scar without a scab or stitch sinus)
3 secondary outcomes
Procedure time
Time frame: Less than 15 minutes
Parental satisfaction
Time frame: 4 weeks
Neonatal pain scale (NIPS)
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- Derived from this study: PubMed 27597563Kankaka EN, Murungi T, Kigozi G, Makumbi F, Nabukalu D, Watya S, Kighoma N, Nampijja R, Kayiwa D, Nalugoda F, Serwadda D, Wawer M, Gray RH. Randomised trial of early infant circumcision performed by clinical officers and registered nurse midwives using the Mogen clamp in Rakai, Uganda. BJU Int. 2017 Jan;119(1):164-170. doi: 10.1111/bju.13589. Epub 2016 Sep 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald H Gray, MD MSc principal investigator
Johns Hopkins Bloomberg School of Public Health
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Neonatal circumcision under topical anesthesia in people with Neonatal Male Circumcision, run by Johns Hopkins Bloomberg School of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events related to circumcision (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02596282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.