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临床试验/NCT01167517
NCT01167517已完成不适用

Lactation Education Study in Mothers of Very Low Birth Weight Infants

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Maternal breast milk proportion of enteral feeding.

研究概览

简要总结

This study will test the effectiveness of breast milk expression discharge instructions in digital video disc (DVD) format for home use by mothers of very low birth weight infants on the dose and duration of mother's breast milk feeding in their infants compared to breast milk expression discharge instructions in printed format. The investigators hypothesize that infants whose mothers receive breast milk expression discharge instructions via DVD will receive a larger dose of maternal breast milk and for longer duration during the initial neonatal intensive care unit hospitalization than infants whose mothers receive discharge instructions in printed format.

详细描述

Very low birth weight (VLBW; <1500 g) infants who receive maternal breast milk, as opposed to infant formula, are less likely to experience the serious illnesses and poor developmental outcomes associated with VLBW. However, a disparity exists in breast milk feeding. Infants whose mothers have low educational attainment and low income are less likely to receive maternal breast milk than infants whose mothers who do not have low educational attainment and low income. The primary objective of this proposed research is to determine the effect of lactation discharge instructions in an audio-visual format provided to mothers for home viewing on the dose and duration of maternal breast milk received by their VLBW infants during the neonatal intensive care unit hospitalization.

Methods. Forty mothers of VLBW infants will be randomly assigned to receive a breast milk expression instruction digital video disc (DVD) in addition to standard of care lactation education or assigned to receive written instructions in addition to standard of care lactation education. In addition to comparing infant intake of maternal breast milk intake, pre and post intervention lactation and breast milk expression knowledge will be compared between groups and DVD viewing frequency and acceptability will be determined with a log and questionnaire to be completed by the intervention group and collected the first month after delivery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Infant birth weight less than 1500 grams
  • Maternal educational attainment less than/equal to 12 years
  • Maternal low income status (Medicaid participant prior to delivery)

排除标准

  • Non-English speaking
  • Illicit drug use during pregnancy

结局指标

主要结局

Maternal breast milk proportion of enteral feeding.

时间窗: Daily during the initial hospitalization which is an average of 60 days

Volume (ml) of maternal breast milk received daily by the infant divided by the total daily volume of all enteral feeding received.

Volume of daily maternal milk intake in relation to infant weight.

时间窗: Daily during the initial hospitalization which is an average of 60 days

Daily maternal milk intake(ml)divided by daily infant weight (kilograms).

次要结局

  • Maternal lactation and breast milk expression knowledge.(One month postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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