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临床试验/NCT03619369
NCT03619369已完成不适用

Timing of Circumcision and Breastfeeding Frequency: A Randomized Clinical Trial

Brooke Army Medical Center2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Breastfeeding Rates

研究概览

简要总结

  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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 6 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •All male infants born at the 3 participating sites

排除标准

  • •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.

研究组 & 干预措施

Early Circumcision

Active Comparator

干预措施: Circumcision (Procedure)

Routine Circumcision

Placebo Comparator

干预措施: Circumcision (Procedure)

Delayed Circumcision

Active Comparator

干预措施: Circumcision (Procedure)

结局指标

主要结局

Breastfeeding Rates

时间窗: From birth thru 6 months of age

Exclusive Breastfeeding Rates

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Thornton Mu

Neonatologist

Brooke Army Medical Center

研究点 (2)

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