Clinical trial NCT06563726: Sodium Awareness in Lactation Trial
Official title: Partnering With Parents for Pumping Success: Feasibility of Personalized Lactation Support Utilizing Point-of-Care Human Milk Biomarkers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding
Preterm Birth
Breast Pumping
Lactation; Insufficient, Partial
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2024-08-21
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: multi-centre, non-blinded, non-randomized prospective interventional pilot study
Primary purpose: DIAGNOSTIC

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. Consent provided
2. 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
3. Day 5 or less postpartum (Day 1 = day of delivery) upon enrollment (ideally day 3 or less)
4. Plans to lactate at least 2 weeks and initiate lactation with a breast pump
5. Expected infant NICU stay of 7+ (ideally 14+) days in enrollment NICU(s)

Exclusion Criteria:

1. 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
2. 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)
3. Lactation contraindication(s) (i.e., active chemotherapy) or declines lactation initiation
4. History of breast surgery that may affect ability to lactate (i.e., breast reduction; breast augmentation that utilized nipple incisions)
5. Using or planning to use hormonal birth control in the first 14 days post-partum as may affect secretory activation/lactation
6. Unable/unwilling to be present in study NICU during any of first 5 days postpartum
7. Presumption by the medical team that infant will be in study NICU for \<5 days

Primary outcomes:
measure: Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: economic
timeFrame: First 14 days postpartum
measure: Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via interviews
timeFrame: First 14 days postpartum
measure: Establish feasibility of parent-led longitudinal parent milk Na testing in the first 14 days postpartum: parent acceptance via surveys
timeFrame: First 14 days postpartum
Secondary outcomes:
measure: Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na levels and longer term lactation outcomes (milk provision at NICU discharge).
timeFrame: Enrollment to infant NICU discharge, up to 52 weeks (average NICU stay is about 10 weeks)
measure: Investigate inter-relationships between pumping frequency, parent lactation risk factors, daily milk Na and short term lactation outcomes (coming to volume)
timeFrame: First 14 days postpartum
Other outcomes:
measure: Explore if POC Na data used to recommend changes in pumping behaviour is associated with actual changes in parent pumping behaviour
timeFrame: First 14 days postpartum
measure: Explore how POC Na data used to recommend changes in pumping behaviour is associated with short-term milk volumes
timeFrame: First 14 days postpartum
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center - Montlake
state: Washington
Study officials:
affiliation: The Hospital for Sick Children
name: Samantha J. Anthony, PhD
role: PRINCIPAL_INVESTIGATOR
References: