Partnering With Parents for Pumping Success: Feasibility of Personalized Lactation Support Utilizing Point-of-Care Human Milk Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: economic
研究概览
简要总结
SALT is a multi-centre, non-blinded, non-randomized prospective interventional pilot study teaching lactating parents of hospitalized preterm infants how to test their breastmilk sodium (Na) using point-of-care (POC) meters. A drop in Na is a sign of secretory activation in the breast that is associated with adequate short and long-term breast milk volumes in this vulnerable population.
Primary Objective: Establish feasibility, acceptance, and time cost of parent-led parent milk Na testing in the first 14 days postpartum
Secondary Objective: Further investigate relationships between pumping behaviours, lactation risk factors, daily milk Na and lactation outcomes
Exploratory Objective: Explore how POC Na data may be used to modify pumping behaviour and milk volumes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consent provided
- •Have delivered a preterm singleton or twin infant at <35 weeks gestation admitted to a study NICU at birth or transferred into a study NICU from another NICU within the first 72 hours postpartum
- •Day 5 or less postpartum (Day 1 = day of delivery) upon enrollment (ideally day 3 or less)
- •Plans to lactate at least 2 weeks and initiate lactation with a breast pump
- •Expected infant NICU stay of 7+ (ideally 14+) days in enrollment NICU(s)
排除标准
- •Potential study participant's infant is critically ill and not expected to survive or has lethal diagnosis with plans by medical team/family to redirect care
- •Has delivered triplets or higher order multiples (potential confounder for lactation challenges; of note, triplets or higher are rare, on the order of a few parents annually)
- •Lactation contraindication(s) (i.e., active chemotherapy) or declines lactation initiation
- •History of breast surgery that may affect ability to lactate (i.e., breast reduction; breast augmentation that utilized nipple incisions)
- •Using or planning to use hormonal birth control in the first 14 days post-partum as may affect secretory activation/lactation
- •Unable/unwilling to be present in study NICU during any of first 5 days postpartum
- •Presumption by the medical team that infant will be in study NICU for <5 days
结局指标
主要结局
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: economic
时间窗: First 14 days postpartum
We will collect time cost of milk testing, including teaching parents how to test milk and daily time testing milk. This outcome will include time (in hours) spent in the first 14 days for parent and staff, with a health economist determining costs for that time
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via interviews
时间窗: First 14 days postpartum
We will collect qualitative data on parent acceptance and feelings about Na testing from parent interviews
Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via surveys
时间窗: First 14 days postpartum
We will collect qualitative data on parent acceptance and feelings about Na testing from parent surveys
次要结局
- Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na levels and longer term lactation outcomes (milk provision at NICU discharge).(Enrollment to infant NICU discharge, up to 52 weeks (average NICU stay is about 10 weeks))
- Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na and short term lactation outcomes (coming to volume)(First 14 days postpartum)
研究者
Samantha Anthony
Health Clinician Scientist, Associate Professor
The Hospital for Sick Children