ChiCTR1800018193Active, not recruitingNot Applicable
比较顺序与同时双侧吸乳法在产后无法即时哺乳者中对泌乳开始时间和维持泌乳量的随机化对照试验
研究者发起项目1 site in 1 country150 target enrollmentStarted: March 1, 2018Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- 乳汁体积差
Study Overview
Brief Summary
本研究旨在探讨因某些原因在婴儿出生后 1 小时内不能直接吸吮时，单侧顺序与双侧同时吸乳对泌乳开始时间的影响；对已经开始直接喂哺的母亲，偶尔婴儿不在身边需要规律吸乳时，单侧顺序吸乳和双侧同时吸乳对维持泌乳量的差异；以及最终对此类人群的哺乳持续时间和喂哺方式的影响，比如提高产后 6 个月时纯母乳直接喂哺的比例。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 随机平行对照
- Masking
- N/a
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •(1) 分娩前有直接哺乳意愿;
- •(2) 计划必要时吸乳;
- •(3) 产假≥4 个月;
- •(4) 年龄 20～40 岁;
- •(5) 参加过医院提供的产前母乳喂养课程;
- •(6) 孕周≥34 周、出生体重≥2000 g 或剖宫产(包括晚期早产和足月产儿、双胎和单胎);
- •(7) Apgar 评分(1 min) ≥7;
- •注：晚期早产占早产儿的 3/4，新生儿死亡率和发病风险增加，即黄疸、喂养不良、呼吸窘迫、低血糖和败血症[J Obstet Gynecol Neonatal Nurs 2011,40:9-24; BMC pediatrics 2016,16:179]。
Exclusion Criteria
- •(1) 母亲有直接哺乳禁忌症，如活动性传染病或传染病筛查指标阳性、弱智妇女或正使用的药物有可能能过母乳影响婴儿;
- •(2) 有饮酒或吸烟问题的母亲;
- •(3) 可能在母乳直接喂哺方面有缺陷的重大畸形婴儿;
- •(4) 婴儿直接哺乳禁忌症;
- •(5) 拒绝参加本次试验。
Arms & Interventions
研究组 1（双侧同时吸乳组）
双边电动吸乳器
单侧续贯吸乳组
单边电动吸乳器
对照组
Outcomes
Primary Outcomes
乳汁体积差
泌乳开始时间
Secondary Outcomes
- 母乳喂哺方式
- 纯母乳喂养持续时间
- 纯母乳喂养率
Investigators
Study Sites (1)
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