跳至主要内容
临床试验/NCT06061913
NCT06061913已完成不适用

Comparison of Breast Pump Suction Patterns in Achievement of Coming to Volume in Breast Pump-Dependent Mothers of Critically Ill Infants

University of Florida1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
Pumped milk volume

研究概览

简要总结

Compare effectiveness of breast pump patterns on lactation outcomes of pump dependent mothers of critically ill infants

详细描述

Insufficient Mothers Own Milk (MOM) has its origins during the first 14 days postpartum, a critical window that includes secretory activation (SA; milk coming in; lactogenesis II) and the achievement of coming to volume (CTV; providing 500 mLs/day of MOM by day 14 postpartum). For all lactating mothers, SA must be achieved for lactation to continue, and CTV predicts provision of MOM through to neonatal intensive care unit (NICU) discharge in preterm very low birth weight (VLBW; <1500 g birth weight) infants. For this study, we posit that alternate breast pump suction patterns (BPSP; suction rate, intensity, and rhythm) may facilitate achievement of CTV in mothers who have achieved SA, but whose daily pumped MOM volumes indicate a high risk of not achieving CTV. Therefore, the overall objective of this study is to compare the clinical effectiveness of three different breast pump suction patterns on lactation outcomes, including achievement of SA, among pump dependent mothers of critically ill infants who demonstrate faltering lactation after achievement of SA. At 6-8 days postpartum, 90 pump dependent mothers of critically ill infants who have achieved SA but demonstrate faltering lactation (<350 mLs/day pumped MOM volume), will be randomized to use one of three different BPSPs with two groups having alternative BPSPs and one group using the current practice standard for 7 days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •> 18 years of age
  • •delivered an infant admitted to the NICU
  • •Intent to provide exclusive mother's own milk to their infants for the first 14 days postpartum
  • •Expect to be breast pump dependent for the first 14 days postpartum

排除标准

  • •Breast reduction or augmentation
  • •Infant not expected to survive
  • •Medications or maternal conditions incompatible with providing mother's own milk to a NICU infant
  • •Resides over 60 miles from University of Florida (UFHealth) in Gainesville, FL.

研究组 & 干预措施

Breast Pump Suction Pattern 3

Sham Comparator

干预措施: Breast Pump suction pattern (Behavioral)

Breast Pump Suction Pattern 1

Active Comparator

干预措施: Breast Pump suction pattern (Behavioral)

Breast Pump Suction Pattern 2

Active Comparator

干预措施: Breast Pump suction pattern (Behavioral)

结局指标

主要结局

Pumped milk volume

时间窗: Days 1-15 post-partum

Daily volume of milk pumped daily

次要结局

  • Maintenance of secretory activation(Days 1-15 post-partum)
  • Maternal perceptions of comfort, effectiveness, efficiency, and convenience(Day 15 post-partum)
  • Proportion of infant feeds consisting of mother's own milk .(Days 1 post-partum until 6 months .)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验