Human Milk Diet for Neonatal Abstinence Syndrome

No longer recruiting at 1 trial location

Overseen By Diana Anzueto Guerra

Age: < 18

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Preterm, Major congenital abnormalities, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an exclusive human milk diet can improve recovery for babies with neonatal abstinence syndrome (NAS). Researchers examine how this diet affects the baby's hospital stay, growth, and overall health. Babies in the trial will receive either only human milk or a mix of mother's milk and formula, which represents the standard of care. The study seeks newborns diagnosed with or at risk for NAS who have been fed only human milk so far. As an unphased trial, it offers a unique opportunity to contribute to understanding the potential benefits of human milk for newborns with NAS.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that breast milk is generally safe for babies, including those with neonatal abstinence syndrome (NAS). One study on mothers and their opioid-dependent babies found that breast milk could help improve NAS symptoms, indicating it is well-tolerated by these infants.

Other studies suggest that breastfeeding can lead to shorter hospital stays and milder NAS symptoms. This suggests that breast milk is not only safe but also helpful in easing some of the difficulties these babies face.

Additionally, only very small amounts of certain medications, such as buprenorphine used to treat NAS, pass into breast milk. Importantly, no harmful effects were found in babies due to this.

In summary, current research supports the safety and benefits of breast milk for babies with NAS, making it a promising option for their care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using an exclusive human milk diet for treating Neonatal Abstinence Syndrome (NAS) because it offers a natural and potentially more effective way to support newborns experiencing withdrawal symptoms. Unlike the standard care, which often includes formula feeding and medications like morphine or methadone, human milk provides essential nutrients and bioactive components that may help soothe withdrawal symptoms and promote overall health. Human milk is packed with antibodies and growth factors that could enhance the baby's immune system and development, potentially leading to quicker recovery and shorter hospital stays.

What evidence suggests that an exclusive human milk diet could be effective for neonatal abstinence syndrome?

Research has shown that breast milk can improve symptoms in babies with neonatal abstinence syndrome (NAS). In this trial, one group of participants will receive an exclusive human milk diet, which may include expressed human milk or donor milk. Another group will receive maternal human milk or formula as part of the standard care. One study found that breast milk can ease NAS symptoms, whether from the baby's own mother or a donor. A review suggested that breastfeeding can reduce negative effects in newborns exposed to drugs like methadone before birth. Additionally, donor breast milk has shown potential benefits for babies treated for NAS. Overall, breast milk is considered beneficial for babies with NAS, enhancing their overall well-being. ^{1 3 6 7 8}

Who Is on the Research Team?

Cynthia Blanco, MD, MSCI-TS

Principal Investigator

University of Texas Health at San Antonio

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Randomization and Initial Feeding

Infants are randomized to receive either an exclusive human milk diet or maternal human milk/formula, and initial feeding begins

1 day

Treatment

Infants receive their assigned diet (exclusive human milk or maternal human milk/formula) for 28 days or until hospital discharge

28 days

Follow-up

Participants are monitored for growth velocity and body composition using Peapod at 28 days or discharge

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Human Milk
• Standard of Care

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Human Milk for:

• Nutritional support for infants
• Neonatal Abstinence Syndrome

Approved in European Union as Human Milk for:

• Nutritional support for infants
• Preterm infant nutrition

Approved in Canada as Human Milk for:

• Nutritional support for infants
• Neonatal care

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Published Research Related to This Trial

A randomized trial is being proposed to compare the effects of a 100% human milk-based diet versus a diet partially based on bovine milk for premature infants, highlighting the importance of human milk in their development.

The study aims to address the long-term physiological benefits of human milk and optimize feeding strategies for preterm infants, as the effects of donor milk are not yet fully understood.

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]

Supplementing human milk with multicomponent fortifiers leads to short-term improvements in weight gain, linear growth, and head growth in premature infants, indicating enhanced nutritional support.

While there are no significant adverse effects noted from fortification, the long-term benefits and potential risks remain unclear, suggesting a need for further research on optimal fortifier compositions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Supplementing human milk with multicomponent fortifiers in premature infants leads to short-term improvements in weight gain and growth measurements, such as linear and head growth.

There is currently insufficient evidence to determine long-term benefits or adverse effects of these fortifiers, although they do not appear to cause significant harm in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Premature infants receiving human milk-derived fortifiers (HM-fort) experienced a higher prevalence of hypoglycemia, with 39.1% having blood glucose levels below 60 mg/dL compared to 23.9% in those receiving bovine-derived fortifiers (Bov-fort).

Feeding extensions due to hypoglycemia were significantly more common in the HM-fort group (24%) compared to the Bov-fort group (0%), indicating that HM-fort may be less effective in maintaining stable blood glucose levels in premature infants.

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]

Human milk is the best nutrition for term newborns, but its use is lower than desired, especially among infants of black mothers and those in neonatal intensive care units.

While individual-level interventions can effectively increase human milk intake, some system-level interventions may be ineffective or even harmful, highlighting the need for supportive public policies that promote breastfeeding while ensuring equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Human milk has been shown to significantly benefit both preterm and term infants, including those with serious health conditions, by promoting gut health, growth, and neurocognitive development.

Research indicates that specific human milk diets can lower the risk of certain diseases, and ongoing studies aim to enhance donor human milk products to improve outcomes for infants who cannot receive their own mother's milk.

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]

Donor human milk is considered a safe and effective alternative for feeding extremely preterm infants when their mother's milk is not available, supported by clinical data on its benefits.

The article proposes a risk assessment methodology for milk banks worldwide to evaluate and enhance the safety of their processes, ensuring quality control in donor selection and pasteurization techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Donor human milk is recommended by the World Health Organization for infant feeding when mother's milk is unavailable, and it has been shown to improve health outcomes in low birthweight infants by reducing serious conditions like necrotising enterocolitis and late onset sepsis.

In a series of seven case studies involving orphaned and abandoned children, many HIV exposed or positive, the use of pasteurized donor human milk showed potential protective effects against failure to thrive, diarrhea, atopic dermatitis, and opportunistic infections, despite limited medical records.

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]

Donor human milk can provide therapeutic benefits to infants, but its use should be based on a careful assessment of the benefits versus known risks, which can vary based on donor selection and processing methods.

High ethical standards are essential in the collection and use of donor human milk to ensure the safety of both donors and recipients, and any supplementation should be done cautiously to avoid interfering with maternal breastfeeding.

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]

Donor human milk is increasingly used for very low birth weight (VLBW) preterm infants and may reduce the risk of necrotizing enterocolitis and improve neurodevelopmental outcomes compared to formula feeding.

The exclusive human milk diet shows potential in lowering the risk of necrotizing enterocolitis, but further research is needed to fully understand its effects on infections, growth, and neurodevelopment in VLBW infants, as well as the impact of different milk fortifiers.

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]

A study of 25 samples of donor human milk (DHM) showed that key nutrients like lactose, protein, and immunoglobulin A (IgA) remained stable over 4 days of refrigerated storage, indicating that DHM maintains its nutritional quality during this time.

DHM consistently had low levels of aerobic bacteria after pasteurization, with 81% of samples showing less than 102 colony-forming units (CFUs), while infant formula had significantly higher bacterial counts, suggesting that DHM is a safer option for infants in need.

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8663542/

A Meta-Analysis of Breastfeeding Effects for Infants With ...

One retrospective cohort study evaluated opioid-dependent mother–infant pairs and observed that human milk could improve NAS symptoms regardless of infant ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0884217519300462

Systematic Review of Newborn Feeding Method and ...

Conclusion. Breastfeeding may be effective to mitigate negative outcomes related to NAS among newborns exposed to methadone in utero. Women who are stable on ...

3.

huskiecommons.lib.niu.edu

huskiecommons.lib.niu.edu/cgi/viewcontent.cgi?article=1244&context=studentengagement-honorscapstones

Breast Milk for Infants with Neonatal Abstinence Syndrome

The goal of this literature review is to examine a variety of research based articles to determine the effectiveness of breast milk on infants ...

4.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/73/NCT02182973/Prot_SAP_000.pdf

Donor human milk for infants with Neonatal Abstinence ...

... NAS, this study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS.

5.

publications.aap.org

publications.aap.org/pediatrics/article/137/5/e20153835/52012/Improving-Care-for-Neonatal-Abstinence-Syndrome

Improving Care for Neonatal Abstinence Syndrome

Patient-level outcomes for NAS included LOT, LOS, discharge on human milk, discharge with a parent, and discharge on a medication. The audit ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6211775/

The Impact of Breastfeeding on Health Outcomes for Infants ...

Collectively, the studies show a strong correlation between breastfeeding and a reduced length of hospital stay, a decreased severity of NAS ...

7.

cps.ca

cps.ca/en/documents/position/nas-nows

Managing newborns at risk for neonatal abstinence ...

Direct breast/chest and expressed human milk feeding should be encouraged because it can delay onset and decrease severity of withdrawal ...

8.

publications.aap.org

publications.aap.org/pediatrics/article/150/1/e2022057989/188348/Technical-Report-Breastfeeding-and-the-Use-of

Technical Report: Breastfeeding and the Use of Human Milk

Buprenorphine has poor oral bioavailability, and only small amounts of buprenorphine enter human milk, with no adverse effects found in infants.