Circumcision and Breastfeeding

• Sponsor: Brooke Army Medical Center (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT03619369
• Collaborator: United States Naval Medical Center, San Diego (U.S. Fed), Dartmouth-Hitchcock Medical Center (Other)
• Enrollment: 150
• Locations: 2
• Arms: 3
• Actual Duration (Months): 36.4
• Patients Per Site: 75
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

2. 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.

Condition or Disease	Intervention/Treatment	Phase
Breastfeeding, Exclusive; Circumcision	Procedure: Circumcision	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Timing of Circumcision and Breastfeeding Frequency: A Randomized Clinical Trial
• Actual Study Start Date: May 20, 2016
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Early Circumcision	Procedure: Circumcision; Early vs. Routine vs. Delayed Circumcision and their impact on exclusive breastfeeding rates
Placebo Comparator: Routine Circumcision	Procedure: Circumcision; Early vs. Routine vs. Delayed Circumcision and their impact on exclusive breastfeeding rates
Active Comparator: Delayed Circumcision	Procedure: Circumcision; Early vs. Routine vs. Delayed Circumcision and their impact on exclusive breastfeeding rates

Outcome Measures

Primary Outcome Measures

1. Breastfeeding Rates [From birth thru 6 months of age]

   Exclusive Breastfeeding Rates

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• All male infants born at the 3 participating sites

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Naval Medical Center San Diego	San Diego	California	United States
2	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States

Sponsors and Collaborators

• Brooke Army Medical Center
• United States Naval Medical Center, San Diego
• Dartmouth-Hitchcock Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thornton Mu, Neonatologist, Brooke Army Medical Center
• ClinicalTrials.gov Identifier: NCT03619369
• Other Study ID Numbers: C.2016.112d
• First Posted: Aug 7, 2018
• Last Update Posted: Jul 17, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 17, 2019