Human Milk Diet for Neonatal Abstinence Syndrome

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Cynthia Blanco, MD, MSCI-TS

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The University of Texas Health Science Center at San Antonio

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

A clinical trial to evaluate length of stay, growth velocity and clinical outcomes in infants with neonatal abstinence syndrome receiving an exclusive human milk diet. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether participants must stop taking their current medications. However, since the trial focuses on infants with neonatal abstinence syndrome and an exclusive human milk diet, it is likely that any medication changes would be discussed with the healthcare provider.

What data supports the idea that Human Milk Diet for Neonatal Abstinence Syndrome is an effective treatment?

The available research shows that human milk, including donor milk, can be beneficial for infants, especially those born prematurely or with low birth weight. It is associated with a reduced risk of serious intestinal issues and better developmental outcomes compared to formula. Although the studies focus on other conditions, these benefits suggest that a human milk diet could be effective for Neonatal Abstinence Syndrome as well. However, more specific research is needed to confirm its effectiveness for this particular condition. ^{1 2 3 4 5}

What safety data exists for using human milk in treating neonatal abstinence syndrome?

The safety of using human milk, including donor human milk, has been evaluated in various studies. Donor human milk is considered safe and effective for feeding preterm infants when the mother's own milk is unavailable. Safety measures include strict donor selection, pasteurization techniques, and quality control. Human milk-derived products require careful risk assessments due to variations in donor selection and processing methods. Additionally, human milk-derived fortifiers have been linked to hypoglycemia in some cases, indicating the need for cautious use. Overall, human milk is promoted based on extensive evidence supporting its benefits and safety. ^{2 6 7 8 9}

Is Human Milk a promising treatment for Neonatal Abstinence Syndrome?

Yes, Human Milk is a promising treatment because it can provide essential nutrients, boost immunity, and improve outcomes for infants, especially those who are vulnerable or premature. It may also reduce the risk of serious conditions like necrotizing enterocolitis compared to formula. ^{1 3 5 10 11}

Research Team

Cynthia Blanco, MD, MSCI-TS

Principal Investigator

University of Texas Health at San Antonio

Eligibility Criteria

This trial is for full-term infants (born at ≥37 weeks) who are 2 days old or less, diagnosed with or at risk for neonatal abstinence syndrome. Infants must not have any major genetic abnormalities, lethal organ defects, or conditions affecting survival/intestinal health. Parents must agree to an exclusive human milk diet and follow-up procedures.

Inclusion Criteria

Parent(s) willing to sign informed consent.

My newborn is at risk for or diagnosed with neonatal abstinence syndrome and is 2 days old or younger.

Infant feeding was NPO (nil per os) or consisted of 100% human milk diet prior to randomization.

Exclusion Criteria

I am less than 37 weeks pregnant.

My baby is older than 2 days and is being checked for withdrawal symptoms.

Any comorbidity or significant clinical event prior to enrollment, deemed by the Investigator as likely to affect survival or intestinal health.

Treatment Details

Interventions

• Human Milk (Other)
• Standard of Care (Other)

Trial Overview The study tests whether an exclusive diet of human milk can reduce hospital stay length and improve growth in newborns with neonatal abstinence syndrome. Human milk includes mother's expressed milk, donor milk, and its derivatives like fortifiers designed specifically from human milk.

Participant Groups

Group I: Maternal human milk or Formula Experimental Treatment 1 Intervention

Group Two (Control Group) will receive maternal human milk or formula (per standard of care).

Group II: Exclusive Human Milk Active Control 1 Intervention

Group One will receive an exclusive human milk diet throughout the 28-day feeding period or until hospital discharge

Human Milk is already approved in Canada for the following indications:

Approved in Canada as Human Milk for:

• Nutritional support for infants
• Neonatal care

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MARC - The University of Texas Health Science Center San Antonio, TX

University Health System, Robert B Green San Antonio, TX

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Patients Recruited

92,500+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human milk banking-facts and issues to resolve. Corpeleijn, WE., Vermeulen, MJ., van Vliet, I., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human milk-derived fortifiers are linked with feed extension due to Hypoglycemia in infants Ackley, D., Wang, H., D'Angio, CT., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donor human milk for preterm infants: what it is, what it can do, and what still needs to be learned. Colaizy, TT.[2016]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Milk for the Term Newborn. Von Kohorn, I., Flaherman, V.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using donor human milk to feed vulnerable term infants: a case series in KwaZulu Natal, South Africa. Reimers, P., Shenker, N., Weaver, G., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes improved with human milk intake in preterm and full-term infants. Chetta, KE., Schulz, EV., Wagner, CL.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donor human milk banking and the emergence of milk sharing. Landers, S., Hartmann, BT.[2012]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Refrigerated Storage of Donor Human Milk with Limited Bacterial Presence After Holder Pasteurization on Nutrient Concentration and Bacterial Growth. McCune, S., Perrin, M.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit by design: Determining the 'value' of donor human milk and medical products derived from human milk in NICU. Hartmann, BT.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicomponent fortified human milk for promoting growth in preterm infants. Kuschel, CA., Harding, JE.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicomponent fortified human milk for promoting growth in preterm infants. Kuschel, CA., Harding, JE.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Human milk banking-facts and issues to resolve. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Human milk-derived fortifiers are linked with feed extension due to Hypoglycemia in infants [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Donor human milk for preterm infants: what it is, what it can do, and what still needs to be learned. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Human Milk for the Term Newborn. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Using donor human milk to feed vulnerable term infants: a case series in KwaZulu Natal, South Africa. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Outcomes improved with human milk intake in preterm and full-term infants. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Donor human milk banking and the emergence of milk sharing. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

The Effects of Refrigerated Storage of Donor Human Milk with Limited Bacterial Presence After Holder Pasteurization on Nutrient Concentration and Bacterial Growth. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Benefit by design: Determining the 'value' of donor human milk and medical products derived from human milk in NICU. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Multicomponent fortified human milk for promoting growth in preterm infants. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Multicomponent fortified human milk for promoting growth in preterm infants. [2020]