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临床试验/NCT01428232
NCT01428232已完成不适用

Comparison of Two Clinic-based Interventions to Promote Early Initiation and Exclusive Breastfeeding Through 6 Months After Birth in Kinshasa, Democratic Republic of Congo

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 992 人开始时间: 2012年5月1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
992
试验地点
1
主要终点
Exclusive breastfeeding rate

研究概览

简要总结

A cluster-randomized controlled trial will be conducted in the Democratic Republic of Congo to compare rates of early initiation and exclusive breastfeeding between mothers who give birth in hospitals with the current standard of care, mothers who give birth in hospitals that have implemented the first nine steps of the Baby-Friendly Hospital Initiative, and mothers who give birth in hospitals that have implemented all ten steps of the Baby-Friendly Hospital Initiative, with the 10th step being the provision of breastfeeding support during well-child clinic visits.

详细描述

If at least 90% of children were exclusively breastfed for the first 6-months of life, the potential reduction in mortality that can be achieved will be higher than for any other interventions with sufficient evidence of effect. In the DRC >500,000 under-five deaths occurred in 2008. While >95% of children were breastfed at some point, 18% received something other than breast milk before initiation of breastfeeding, and half received something other than human milk by 1.4 months. Pre- and post-partum breastfeeding support has been shown to best improve the rate of exclusive breastfeeding (EBF). The global initiatives to improve breastfeeding practices have focused on maternity-level policies and procedures known as the Ten Steps to Successful Breastfeeding, which served as the basis for the Baby-Friendly Hospital Initiative. These quality of care steps impact hospital breastfeeding rates as well as breastfeeding rates throughout the 6 months postpartum period. However, EBF rates fall off rapidly in the DRC. In the proposed cluster randomized controlled trial, we plan to evaluate the effect of breastfeeding support provided by well-child clinic staff including the use of culturally appropriate messages in addition to the implementation of BFHI steps 1-9 Steps in maternities on the rate of breastfeeding initiation within 1 hour of birth and EBF throughout 6 months postpartum. If effective, this approach has great potential for scale up where most needed.

研究设计

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

入排标准

年龄范围
— 至 3 Days(Child)
性别
All
接受健康志愿者
是

入选标准

  • •mothers of healthy infants being discharged from participating maternities who intend to attend well-baby clinic visits in the same health care facilities until the child will be at least 6 months

排除标准

  • •refusal to participate, not speaking Lingala nor French, unable to breastfeed

研究组 & 干预措施

BFHI steps 1-9

Experimental

Hospital retrained in BFHI steps 1-9 Mothers can call hospital to obtain BF support/Mothers given phone # of maternity nurse whom she can call or go see if she has BF problems

干预措施: implementation of the Baby-Friendly Hospital Initiative (Other)

BFHI steps 1-9 +well-child clinic

Experimental

Hospital retrained in BFHI steps 1-9 Mothers can call hospital to obtain BF support/Mothers given phone # of maternity nurse whom she can call or go see if she has BF problems Provision of BF support during 1) clinic visit to obtain birth certificate or home visit if mother does not come into clinic and 2) well-child clinics Flyers to mother with culturally appropriate messages designed to address some of the most important local barrier to EBF

干预措施: BFHI steps 1-9 +well-child clinic (Other)

usual care

No Intervention

结局指标

主要结局

Exclusive breastfeeding rate

时间窗: up to 6 months after birth

Infants will be classified as exclusively breastfed if they received only breast milk (no water, other liquids, or solids)

Early initiation of breastfeeding

时间窗: Within 1 hour of birth

initiation of breastfeeding within one hour of birth

次要结局

  • Episodes of diarrhea(in the first 6 months of life)
  • Episodes of Lower Respiratory Track Infection(in the first 6 months of life)
  • Partial Breastfeeding rate(up to 6 months after birth)
  • Number of hospitalization(in the first 6 months of life)
  • Number of mothers seeking breastfeeding help(in the first 6 months of life)
  • Amount and type of breastfeeding support given by Health care provider to mothers(in the first 6 months after birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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