Circumcision and Breastfeeding
Timing of Circumcision and Breastfeeding Frequency: A Randomized Clinical Trial
1 other identifier
interventional
150
1 country
2
Brief 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. 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. 3\) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2016
CompletedFirst Submitted
Initial submission to the registry
August 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJuly 17, 2019
July 1, 2019
3 years
August 2, 2018
July 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Breastfeeding Rates
Exclusive Breastfeeding Rates
From birth thru 6 months of age
Study Arms (3)
Early Circumcision
ACTIVE COMPARATORRoutine Circumcision
PLACEBO COMPARATORDelayed Circumcision
ACTIVE COMPARATORInterventions
Early vs. Routine vs. Delayed Circumcision and their impact on exclusive breastfeeding rates
Eligibility Criteria
You may qualify if:
- All male infants born at the 3 participating sites
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brooke Army Medical Centerlead
- United States Naval Medical Center, San Diegocollaborator
- Dartmouth-Hitchcock Medical Centercollaborator
Study Sites (2)
Naval Medical Center San Diego
San Diego, California, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Related Publications (1)
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.
PMID: 35574656DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neonatologist
Study Record Dates
First Submitted
August 2, 2018
First Posted
August 7, 2018
Study Start
May 20, 2016
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
July 17, 2019
Record last verified: 2019-07