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Circumcision and Breastfeeding

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ClinicalTrials.gov Identifier: NCT03619369
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborators:
United States Naval Medical Center, San Diego
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Thornton Mu, Brooke Army Medical Center

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.


Condition or disease Intervention/treatment Phase
Breastfeeding, Exclusive Circumcision Procedure: Circumcision Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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




Primary Outcome Measures :
  1. Breastfeeding Rates [ Time Frame: From birth thru 6 months of age ]
    Exclusive Breastfeeding Rates



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619369


Contacts
Contact: Lisa Mondzelewski lisa.m.mondzelewski.mil@mail.mil

Locations
United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States
Contact: Lisa Mondzelewski       lisa.m.mondzelewski.mil@mail.mil   
Principal Investigator: Lisa Mondzelewski         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States
Contact: Alison Holmes       Alison.V.Holmes@hitchcock.org   
Principal Investigator: Alison Holmes         
Sponsors and Collaborators
Brooke Army Medical Center
United States Naval Medical Center, San Diego
Dartmouth-Hitchcock Medical Center

Responsible Party: Thornton Mu, Neonatologist, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT03619369     History of Changes
Other Study ID Numbers: C.2016.112d
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No