19 Participants Needed

Human Milk Diet for Neonatal Abstinence Syndrome

Recruiting at 1 trial location
CB
DA
Overseen ByDiana Anzueto Guerra
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.26789

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.1351011

Research Team

CB

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.
See 1 more

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.
See 5 more

Treatment Details

Interventions

  • Human Milk
  • Standard of Care
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Maternal human milk or FormulaExperimental Treatment1 Intervention
Group Two (Control Group) will receive maternal human milk or formula (per standard of care).
Group II: Exclusive Human MilkActive Control1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

Findings from Research

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.
Human milk banking-facts and issues to resolve.Corpeleijn, WE., Vermeulen, MJ., van Vliet, I., et al.[2021]
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.
Human milk-derived fortifiers are linked with feed extension due to Hypoglycemia in infantsAckley, D., Wang, H., D'Angio, CT., et al.[2023]
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.
Donor human milk for preterm infants: what it is, what it can do, and what still needs to be learned.Colaizy, TT.[2016]

References

Human milk banking-facts and issues to resolve. [2021]
Human milk-derived fortifiers are linked with feed extension due to Hypoglycemia in infants [2023]
Donor human milk for preterm infants: what it is, what it can do, and what still needs to be learned. [2016]
Human Milk for the Term Newborn. [2021]
Using donor human milk to feed vulnerable term infants: a case series in KwaZulu Natal, South Africa. [2023]
Outcomes improved with human milk intake in preterm and full-term infants. [2022]
Donor human milk banking and the emergence of milk sharing. [2012]
The Effects of Refrigerated Storage of Donor Human Milk with Limited Bacterial Presence After Holder Pasteurization on Nutrient Concentration and Bacterial Growth. [2023]
Benefit by design: Determining the 'value' of donor human milk and medical products derived from human milk in NICU. [2020]
Multicomponent fortified human milk for promoting growth in preterm infants. [2018]
Multicomponent fortified human milk for promoting growth in preterm infants. [2020]