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OpenTrials
Completed

NCT Number: NCT03619369

Circumcision and Breastfeeding

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.

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Key information

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Circumcision

Procedure

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

Primary outcomes

  1. Breastfeeding Rates

    Time frame: From birth thru 6 months of age

    Exclusive Breastfeeding Rates

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Collaborators

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

Registry information

Official study title

Timing of Circumcision and Breastfeeding Frequency: A Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2018
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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