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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03619369
Other study ID # C.2016.112d
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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