Circumcision and Breastfeeding

Breastfeeding, Exclusive Clinical Trial

Official title:

Timing of Circumcision and Breastfeeding Frequency: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619369
• Other study ID #: C.2016.112d
• Status: Completed
• Phase: N/A
• Start date: May 20, 2016
• Est. completion date: June 2019

Study information

• Verified date: July 2019
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Breastfeeding, Exclusive
• Circumcision

Intervention

Procedure:
• Circumcision
Early vs. Routine vs. Delayed Circumcision and their impact on exclusive breastfeeding rates

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Brooke Army Medical Center	Dartmouth-Hitchcock Medical Center, United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding Rates	Exclusive Breastfeeding Rates	From birth thru 6 months of age