Sodium Awareness for Premature Birth

(SALT Trial)

Recruiting at 1 trial location

Overseen By Rebecca Hobban, MD, MPH

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Must not be taking: Chemotherapy, Hormonal birth control

Disqualifiers: Critically ill infant, Breast surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for parents of premature babies to check sodium levels in breast milk using simple, point-of-care devices. A drop in sodium can indicate efficient breast milk production, crucial for feeding preterm infants. The trial aims to determine if parents can easily and effectively perform this test themselves within the first two weeks after birth. It suits parents with a preterm baby in the NICU who plan to use a breast pump for at least two weeks. As an unphased trial, this study offers parents the chance to contribute to innovative research that could simplify and improve care for preterm infants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that using hormonal birth control in the first 14 days postpartum is not allowed. If you are on hormonal birth control, you may need to stop it for this trial.

What prior data suggests that parent-led parent milk sodium testing is safe?

Research has shown that using point-of-care (POC) meters to test sodium levels in breastmilk is safe and practical. This method helps parents of premature babies monitor sodium levels, indicating healthy milk production. Studies indicate that early nutrition for preterm infants, including monitoring and adjusting milk, can prevent growth problems and improve long-term health. Testing breastmilk in this manner has shown no negative effects. The focus is on teaching parents to use these meters, a process that has been well-received and easy to manage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for managing sodium levels in premature infants, which typically involve hospital-based interventions and monitoring, the Parent-led Parent Milk Sodium Testing approach empowers parents to test and manage sodium levels in breast milk themselves. This method is unique because it shifts the focus from clinical settings to home-based care, potentially allowing for more immediate and personalized adjustments to an infant's nutritional needs. Researchers are excited about this approach because it could lead to more proactive and tailored care for premature babies, potentially improving their growth and development outcomes by ensuring optimal sodium intake.

What evidence suggests that parent-led milk sodium testing is effective for improving lactation outcomes?

Research has shown that checking sodium levels in breast milk can help predict how well mothers of premature babies will produce milk. One study found that a key step in starting milk production is linked to these sodium levels. Lower sodium levels in breast milk suggest that milk production is progressing well. This information can help mothers adjust their pumping routines to boost milk supply. Using a mother's milk is crucial because it protects against serious conditions like necrotising enterocolitis, a severe intestinal disease, and supports the baby's overall health. ^{2 6 7 8 9}

Who Is on the Research Team?

Samantha J. Anthony, PhD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

The SALT study is for lactating parents with preterm infants (<35 weeks gestation) in the NICU. Participants must consent, be within 5 days postpartum, plan to pump breast milk for at least 2 weeks, and expect their infant's NICU stay to be over a week.

Inclusion Criteria

I have given my consent to participate.

I gave birth to a preterm baby before 35 weeks who was admitted to a NICU.

I plan to breastfeed and start using a breast pump within 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are taught to test their breastmilk sodium using point-of-care meters and modify pumping behavior based on sodium levels

2 weeks

Daily interactions (in-person or virtual)

Follow-up

Participants are monitored for lactation outcomes and milk provision at NICU discharge

Up to 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Parent-led Parent Milk Sodium Testing

Trial Overview This pilot study teaches participants how to test breastmilk sodium levels using POC meters. It aims to determine if this practice is feasible and acceptable, and whether it can influence pumping behavior and improve lactation outcomes.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9105142/

Efficacy of Donated Milk in Early Nutrition of Preterm Infants Compared with formula, donated breast milk could significantly reduce the incidence of NEC, the duration of parenteral nutrition, and the time of full enteral ...

2. withpower.com withpower.com/trial/phase-pumping-breast-8-2024-7f370

Sodium Awareness for Premature Birth (SALT Trial) This pilot study teaches participants how to test breastmilk sodium levels using POC meters. It aims to determine if this practice is feasible and acceptable.

3. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)27958-7/fulltext

Evaluation of the evidence to support current ... Overall, these data suggest that by reducing infectious morbidity, feeding premature infants fortified mother's milk might have a marked effect on reducing the ...

4. researchgate.net researchgate.net/publication/344232059_Mother's_Own_Milk_Biomarkers_Predict_Coming_to_Volume_in_Pump-Dependent_Mothers_of_Preterm_Infants

Mother's Own Milk Biomarkers Predict Coming to Volume ... Conclusion: Secretory activation and CTV were compromised in pump dependent mothers with preterm delivery. CTV was predicted by MOM Na and Na:K ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405457723022416

Principles of feeding the preterm infant Human milk is preferred in preterm infants for its protective effects against necrotising enterocolitis, inflammation, and neurodevelopmental delay.

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/97/NCT03889197/Prot_SAP_ICF_000.pdf

Physiologic Approach to Sodium Supplementation in ... Furthermore, estimated urine sodium losses often exceeded the 3–. 5 mEq/kg/d of Na currently recommended by AAP for preterm infants. Using these ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3875345/

Aggressive Nutrition of the Preterm Infant - PMC Recent studies have demonstrated that early and enhanced “aggressive” nutrition of preterm infants can reduce postnatal growth failure and improve longer-term ...

8. researchgate.net researchgate.net/publication/330732283_Testing_the_feasibility_and_safety_of_feeding_preterm_infants_fresh_mother's_own_milk_in_the_NICU_A_pilot_study

(PDF) Testing the feasibility and safety of feeding preterm ... Conclusions: Using cell-enriched fresh mother's milk to treat premature infants with stage I NEC was safe and feasible. Read more. Last ...

9. publications.aap.org publications.aap.org/pediatrics/article/152/3/e2023061603/193280/Early-Human-Milk-Fortification-in-Infants-Born

Early Human Milk Fortification in Infants Born Extremely ... This trial indicates that early human milk fortification increases length gain velocity and reduces declines in head circumference z scores from birth to term ...