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临床试验/NCT03617549
NCT03617549已完成不适用

A Pilot Test to Evaluate the Effect of Maternal Stress on Breastmilk Quantity and Stress Biomarkers in Mothers and Their Infants

University of Rochester1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2019年6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
27
试验地点
1
主要终点
Correlation between secretory IgA levels in mother's serum and reported stress

研究概览

简要总结

The overall goal of this research is to clarify the relationship between reported maternal stress, biological measures of maternal stress, breast milk biomarkers and milk quantity. Our primary hypothesis is that measures of maternal stress are associated with cortisol, cytokines, and other stress markers in the blood, which impacts breast milk quantity and composition and which may impact infant health.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Baby will remain in mom's legal custody
  • Intends to exclusively breastfeed during the NICU stay
  • Has kept a daily log of milk expression (pump or hand expression) with date/time/quantity since birth of their child
  • Less than 7 days postpartum

排除标准

  • Baby and mother are to be separated due to legal custody issues
  • Medical contraindication to breastfeeding
  • Non-English speaking
  • Unable to answer a written survey in English
  • More than 50% of infant intake is not mother's own milk at 4 weeks postpartum

结局指标

主要结局

Correlation between secretory IgA levels in mother's serum and reported stress

时间窗: 1 month

Mother's stress will be measured using the The Parent Stress Scale: Neonatal Intensive Care Unit. This scale ranges from 1-130 with higher numbers indicating more stress. Serum will be collected from mothers at enrollment and 4 weeks postpartum. Maternal venipuncture will be used to collect an 0.5mL aliquot of whole blood at the time of mother's first morning pump session in the neonatal intensive care unit. IgA will be quantitated using the Millipore Magpix 100 System. Multivariate regression analysis will be used to test for correlations.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Casey Rosen-Carole

Assistant Professor

University of Rochester

研究点 (1)

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