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临床试验/NCT04097860
NCT04097860已完成不适用

Improving Lactation Success in Mothers of Critically Infants Using Personalized Real-Time Biomarker Based Text Messages

University of Florida2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
2
主要终点
Volume of breast milk (BM)

研究概览

简要总结

The purpose of this study is to determine the feasibility and potential benefits of a mHealth intervention to increase BM pumping frequency and BM production in mothers delivering critically ill infants admitted to the neonatal intensive care unit

详细描述

Although compelling evidence exists that breast milk (BM) improves infant health, mothers of critically ill infants frequently produce insufficient amounts BM which is likely due to inadequate daily breast pumping frequency. BM sodium levels are an easy to measure biomarker of pumping frequency and providing this information to mothers via text messaging may increase their pumping frequency and BM production. Therefore, the overall objective of this pilot study is to determine the feasibility and potential benefits of a mHealth intervention to increase BM pumping frequency and BM production in mothers delivering critically ill infants admitted to the neonatal intensive care unit (NICU) at University of Florida Health. Specific aims include (1) evaluate the feasibility of a mHealth intervention to increase BM pumping frequency and BM production and (2) assess whether results indicate a signal of effectiveness supporting a subsequent adequately powered randomized clinical trial (RCT). Following delivery, 50 mothers of critically ill infants admitted to the NICU will be randomized to one of two groups. The Enhanced Intervention Group will receive text messages including both general lactation information and a personalized message consisting of the mother's BM sodium level, pumping frequency and feedback regarding pumping frequency. The Standard Intervention Group will receive only general lactation information. Results will be used to revise the intervention and study processes and to estimate outcome measurement variability and effect sizes needed for sample size calculations for an adequately powered RCT.

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 (Outcomes Assessor)

盲法说明

Individuals monitoring breast milk production and sodium levels will be blinded

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

  • stated intent to provide BM to the infant
  • infant not expected to be stable enough to bottle/breastfeed for > 14 days
  • owns a mobile phone with unrestricted SMS capability.
  • English speaking

排除标准

  • known illicit drug use
  • breast reduction or augmentation
  • positive HIV status
  • does not anticipate being able to bring BM to the NICU at least 4X/week
  • infant not expected to live > 7 days following delivery
  • COVID-19 positive

结局指标

主要结局

Volume of breast milk (BM)

时间窗: Up to 2 weeks

All BM will be weighed (1 mg of BM = 1 mL) by a BM technician and the weight recorded in the infant's medical record. BM will be weighed on a portable digital scale accurate to within 0.1 grams.

次要结局

  • Breast milk sodium level(Up to 2 weeks)
  • Number of breast pumping episodes(Up to 2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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