此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Early Use of Raw Milk and Breastfeeding Continuation (DOAL)

2019年5月3日 更新者:Hospices Civils de Lyon

Early Use of Mother's Own Raw Milk, Maternal Satisfaction, and Breastfeeding Continuation in Hospitalised Neonates: A Prospective Cohort Study

BACKGROUND:

Despite the critical importance of breast milk for preterm and sick neonates, there is no consensus regarding the use of raw mother's own milk (MOM) in neonatal units.

OBJECTIVES:

This study aimed to describe the use of raw MOM in hospitalised neonates before day 7 (early use), and to investigate: (i) related factors, (ii) maternal satisfaction, and (iii) the association with breastfeeding continuation.

METHODS:

This prospective cohort included 516 neonates intended to be breastfed in 2 French neonatal units. Neonates receiving raw MOM before day 7 were compared to those who did not. The association between early use of MOM and breastfeeding continuation at hospital discharge, and up to 6 months later, was measured by logistic regression.

研究概览

地位

完全的

研究类型

观察性的

注册 (实际的)

516

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 6个月 (孩子)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

Neonates male or female admitted between April 2012 andJune 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.

描述

Inclusion Criteria:

  • Eligible neonates were those admitted between April 2012 and June 2013, who were intended to be breastfed and remained hospitalized for 7 days or more.

Exclusion Criteria:

  • Neonates with parents not fluent in French were excluded.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Raw maternal own milk before day 7
Without any intervention, investigators observed whether neonates received raw MOM during the first week of life. Accordingly, the neonates were grouped as "exposed" when they received any raw MOM before day 7, versus "unexposed" when they did not receive any raw MOM before day 7.
No Raw maternal own milk before day 7
Without any intervention, investigators observed whether neonates received raw MOM during the first week of life. Accordingly, the neonates were grouped as "exposed" when they received any raw MOM before day 7, versus "unexposed" when they did not receive any raw MOM before day 7.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in breastfeeding after hospital discharge
大体时间:On Day 60 and Day 180 after hospital discharge
Breastfeeding was defined as the consumption of any mother's own milk (MOM), provided either directly at the breast or after having been expressed. Information on breastfeeding continuation was extracted from the electronic chart during the last 2 days preceding hospital discharge. It was classed as "exclusive" when all the fed milk was MOM, or "partial" when it was completed by other milk and/or food.
On Day 60 and Day 180 after hospital discharge

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sophie Laborie, MD、Hospices Civils de Lyon

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年4月1日

初级完成 (实际的)

2013年12月1日

研究完成 (实际的)

2014年4月1日

研究注册日期

首次提交

2019年4月9日

首先提交符合 QC 标准的

2019年5月3日

首次发布 (实际的)

2019年5月6日

研究记录更新

最后更新发布 (实际的)

2019年5月6日

上次提交的符合 QC 标准的更新

2019年5月3日

最后验证

2019年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • DOAL

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

3
订阅