Circumcision and Breastfeeding

Overview

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.

Full Title of Study: “Timing of Circumcision and Breastfeeding Frequency: A Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2019

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Early Circumcision
  • Placebo Comparator: Routine Circumcision
  • Active Comparator: Delayed Circumcision

Clinical Trial Outcome Measures

Primary Measures

  • Breastfeeding Rates
    • Time Frame: From birth thru 6 months of age
    • Exclusive Breastfeeding Rates

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 6 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brooke Army Medical Center
  • Collaborator
    • United States Naval Medical Center, San Diego
  • Provider of Information About this Clinical Study
    • Principal Investigator: Thornton Mu, Neonatologist – Brooke Army Medical Center

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