Breastfeeding, ExclusiveNCT03619369
Circumcision and Breastfeeding
A study testing Circumcision in people with Breastfeeding, Exclusive and Circumcision, run by Brooke Army Medical Center at 2 sites in United States.
Trial summary
1) To determine when the majority of male infants are being circumcised at 3 hospitals across the US (Brooke Army Medical Center, Naval Medical Center San Diego, and Dartmouth Hitchcock Medical Center. 2) To assess the breastfeeding patterns of circumcised male infants at the above-mentioned academic medical centers. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Exclusive, Circumcision
- What is being tested?
- Circumcision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2016to Jun 2019
- Phase
- Interventional
- 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 Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All male infants born at the 3 participating sites
Who cannot join
- Gestational age <38 weeks, twin/multiple deliveries, NICU admission, mothers who are strictly formula feeding their newborns from the time of delivery, and mothers under 18 years of age.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire
Naval Medical Center San Diego
San Diego, California
About this study
Official title: Timing of Circumcision and Breastfeeding Frequency: A Randomized Clinical Trial
- To determine when the majority of male infants are being circumcised at 3 hospitals across the US (Brooke Army Medical Center, Naval Medical Center San Diego, and Dartmouth Hitchcock Medical Center. 2) To assess the breastfeeding patterns of circumcised male infants at the above-mentioned academic medical centers. Specifically, to determine if these babies are breastfeeding at the time of hospital discharge, at their newborn visit, their 2-week visit, and all subsequent well visits up until 6 months of age.
- To determine if there is a significant relationship between the timing of newborn circumcision and breastfeeding initiation, establishment, and maintenance in the first 6 months of life. We hypothesize that the timing of circumcision will not be significantly associated with frequency of breastfeeding among mother-infant dyads during the initial months of life.
- Conditions
- Breastfeeding, Exclusive, Circumcision
- Being tested
- Circumcision
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircumcisionProcedure or surgery
Early vs. Routine vs. Delayed Circumcision and their impact on exclusive breastfeeding rates
| Study group | Role | What they receive |
|---|---|---|
| Early Circumcision | Active comparator | Not described Receives: Procedure: Circumcision |
| Routine Circumcision | Placebo comparator | Not described Receives: Procedure: Circumcision |
| Delayed Circumcision | Active comparator | Not described Receives: Procedure: Circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Rates
Exclusive Breastfeeding Rates
Measured: From birth thru 6 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start20 May 2016
- Primary completionJun 2019
- Study completionJun 2019
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 Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Naval Medical Center, San Diego, Dartmouth-Hitchcock Medical Center
- Responsible party
- Principal investigator, Thornton Mu, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619369
- Sponsor's protocol ID
- C.2016.112d
- Status last verified
- Jul 2019
- First submitted
- 2 Aug 2018
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mondzelewski L, Mu T, Michalski A, Ward J, Cheng L, Chen M, Riffenburgh R, Holmes A. Timing of Circumcision and Breastfeeding Frequency: A Multicenter, Randomized Clinical Trial. Hosp Pediatr. 2022 Jun 1;12(6):555-560. doi: 10.1542/hpeds.2021-006400.
PubMed 35574656
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Circumcision and Breastfeeding Frequency: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03619369
- Acronym / sponsor ID
- C.2016.112d
- Conditions
- Breastfeeding, Exclusive, Circumcision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- United States Naval Medical Center, San Diego, Dartmouth-Hitchcock Medical Center
- Study start
- 20 May 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 7 Aug 2018 (actual)
- 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.
- To determine when the majority of male infants are being circumcised at 3 hospitals across the US (Brooke Army Medical Center, Naval Medical Center San Diego, and Dartmouth Hitchcock Medical Center. 2) To assess the breastfeeding patterns of circumcised male infants at the above-mentioned academic medical centers. Specifically, to determine if these babies are breastfeeding at the time of hospital discharge, at their newborn visit, their 2-week visit, and all subsequent well visits up until 6 months of age.
- To determine if there is a significant relationship between the timing of newborn circumcision and breastfeeding initiation, establishment, and maintenance in the first 6 months of life. We hypothesize that the timing of circumcision will not be significantly associated with frequency of breastfeeding among mother-infant dyads during the initial months of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Circumcision | Active comparator | Procedure: Circumcision |
| Routine Circumcision | Placebo comparator | Procedure: Circumcision |
| Delayed Circumcision | Active comparator | Procedure: Circumcision |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All male infants born at the 3 participating sites
Key exclusion criteria (1 listed)
- Gestational age <38 weeks, twin/multiple deliveries, NICU admission, mothers who are strictly formula feeding their newborns from the time of delivery, and mothers under 18 years of age.
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 |
|---|---|---|
| CircumcisionEarly vs. Routine vs. Delayed Circumcision and their impact on exclusive breastfeeding rates | Procedure or surgery | Delayed Circumcision, Early Circumcision, Routine Circumcision |
Primary outcome
Breastfeeding Rates
Time frame: From birth thru 6 months of age
Exclusive Breastfeeding Rates
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 17 Jul 2019.
- Derived from this study: PubMed 35574656Mondzelewski L, Mu T, Michalski A, Ward J, Cheng L, Chen M, Riffenburgh R, Holmes A. Timing of Circumcision and Breastfeeding Frequency: A Multicenter, Randomized Clinical Trial. Hosp Pediatr. 2022 Jun 1;12(6):555-560. doi: 10.1542/hpeds.2021-006400.
- Individual participant dataSharing planned: Undecided
Related trials for Breastfeeding, Exclusive
Not yet recruiting
Effect of a Breastfeeding Chatbot on Mothers' Breastfeeding Attitudes, Behaviors, and Self-Efficacy
Breastfeeding, Breastfeeding Attitudes
Not yet recruiting
Healthy Habits During and After Gestational Diabetes
GDM
Recruiting
Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center
Growth & Development, Breastfeeding Satisfaction
RecruitingObservational study
Evaluation of a Health Mediation Program in the Maternity Ward.
Breast Feeding, Exclusive
Recruiting
Hybrid Breastfeeding Education in Late Pregnancy: Effects on Antenatal Attachment and Breastfeeding
Breast Feeding, Exclusive Breast Feeding
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circumcision in people with Breastfeeding, Exclusive and Circumcision, run by Brooke Army Medical Center at 2 sites in United States.
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 1 inclusion and 1 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 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Breastfeeding Rates (time frame: From birth thru 6 months of age). 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 NCT03619369, 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 17 Jul 2019.