跳至主要内容
临床试验/NCT06919718
NCT06919718招募中不适用

Effects of Maternal Stress on Human Milk Composition and Subsequent Infant Outcomes

University of Idaho4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年12月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
4
主要终点
Maternal Stress

研究概览

简要总结

Mothers of preterm infants experience exaggerated emotional stressors compared to those typically associated with new motherhood, making these women particularly vulnerable to postpartum depression. As many as 70% of mothers of preterm infants experience postpartum depression compared to only 12.5% of those delivering full-term infants. Increased stress and depression during this critical period are detrimental because they hamper a mother's ability to care for her infant and are associated with increased neonatal sepsis and mortality, decreased neonatal growth, and delayed motor and cognitive development. Postpartum depression is also associated with excessive maternal weight gain and risk for metabolic diseases, anxiety, and sleep disturbances. Stress in breastfeeding mothers can also alter circulating concentrations of some bioactive components (e.g., immunoglobulins, cortisol) that can transfer into milk. As such, understanding factors predisposing these vulnerable women to extreme levels of stress and finding ways to lower this stress and lessen its negative health outcomes on mothers and infants are important public health challenges. The March of Dimes estimates that 8.5% of births in Idaho are preterm, making this topic particularly relevant for Idaho women. Risk factors for postpartum depression in mothers delivering term or preterm infants are complex, but maternal nutrient deficiencies may be involved. Vitamin D status, for instance, is inversely correlated with risk of postpartum depression in women delivering term infants. However, vitamin D interventions have yielded inconsistent results, perhaps due to confounding impacts of geographic location, skin color, and endogenous vitamin D synthesis. Endogenous vitamin D synthesis requires cutaneous sunlight exposure, placing Idaho women at even greater risk of vitamin D deficiency - particularly in the winter when days are extremely short (only 7 hr on the winter solstice). The impact of maternal vitamin D supplementation during lactation on infant variables (e.g., vitamin D status) has been examined. However, its effect on maternal mental health has not been rigorously studied - let alone in the 'frontier and remote' (FAR) rural West, including Idaho, with short periods of wintertime sunlight and poor access to healthcare. Our long term goal is to develop interventions to improve maternal and infant health in Idaho - particularly in the context of preterm births. The overall primary objective of this proposal is to determine if maternal vitamin D supplementation improves vitamin D status and mental health in Idahoan mothers of preterm infants. Our central hypothesis is that vitamin D supplementation improves vitamin D status and reduces stress and other indicators of poor postpartum maternal mental health in Idaho women delivering preterm infants. Secondarily, we will assess the effects of maternal vitamin D supplementation on human milk composition.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Mothers (>/= 18 years of age) of newborn infants (within first 4 months postpartum) in Idaho

排除标准

  • Mothers (<18 years of age) of newborn infants (within first 4 months postpartum)
  • Infants not anticipated to survive >72 hours

研究组 & 干预措施

Placebo Control

Placebo Comparator

干预措施: Placebo (Other)

Vitamin D

Experimental

干预措施: Vitamin D (Cholecalciferol ) (Dietary Supplement)

结局指标

主要结局

Maternal Stress

时间窗: baseline, 4-week, 8-week

Maternal stress measured by the validated questionnaire: Perceived Stress Scale (PSS). The PSS can range from 0 to 40 with higher scores indicating higher perceived stress: 0-13 = low stress 14-26 = moderate stress 27-40 = high stress

Maternal Vitamin D status

时间窗: baseline, 4-week, 8-week

Blood vitamin D concentration

Maternal Depression

时间窗: baseline, 4-week, 8-week

Maternal depression measured using the validated questionnaire: Edinburgh Postnatal Depression Scale. The Edinburgh Postnatal Depression Scale can range from 0 to 30 with higher scores indicating higher depression. Any total score \>10 indicates depression.

次要结局

  • Maternal Self-Compassion(8-week)
  • Maternal physiologic stress(baseline, 4-week, 8-week)
  • Physiologic Maternal Self-compassion(baseline, 4-week, 8-week)
  • Milk Immunomodulatory Composition(baseline, 4-week, 8-week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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