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Circumcision and Breastfeeding

Brooke Army Medical Center logo

Brooke Army Medical Center

Status

Completed

Conditions

Circumcision
Breastfeeding, Exclusive

Treatments

Procedure: Circumcision

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT03619369
C.2016.112d

Details and patient eligibility

About

  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.

  2. 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.

Enrollment

150 patients

Sex

All

Ages

Under 6 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 3 patient groups, including a placebo group

Early Circumcision
Active Comparator group
Treatment:
Procedure: Circumcision
Routine Circumcision
Placebo Comparator group
Treatment:
Procedure: Circumcision
Delayed Circumcision
Active Comparator group
Treatment:
Procedure: Circumcision

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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