What side effects are associated with this type of intervention?

Common treatments for Neonatal Feeding Disorder, such as protein-enriched human milk diets, aim to support growth and development by increasing fat-free mass and aiding in gut microbiome maturation. Known side effects of these treatments can include metabolic imbalances, such as elevated levels of certain amino acids in plasma, which may not consistently correlate with growth outcomes. Additionally, there is a potential risk of systemic infections and adverse metabolic activities, particularly in immunocompromised infants. Careful monitoring and tailored nutritional strategies are essential to mitigate these risks.

What prior FDA approvals exist?

There is limited specific information on FDA-approved treatments for Neonatal Feeding Disorder that directly align with the protein-enriched human milk diet being studied. However, nutrient-enriched formulas designed for preterm infants have been used to support growth and development post-discharge. These formulas are enriched with additional protein and other nutrients to promote linear growth and weight gain, similar to the goals of the protein-enriched human milk diet. These specialized formulas are intended to address the unique nutritional needs of preterm infants, aiding in their overall development and health.

What other types of research exist?

Promising novel alternatives to Protein-Enriched Human Milk Diet for Neonatal Feeding Disorder patients include Advanced Protein Powder (APP) from ocean-based fish protein and protein hydrolysate formulas. These alternatives have shown potential in supporting growth and development, and further evaluation in human neonates is warranted.

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Protein Supplement

Protein-Enriched Human Milk for Premature Infants

Q: What is the mechanism of action of this treatment?

Protein-enriched human milk diets provide additional protein to support the growth and development of preterm infants. This increased protein intake promotes fat-free mass (FFM) and aids in the maturation of the gut microbiome. These mechanisms are crucial for preterm infants, who have higher nutritional needs and immature digestive systems, making them more susceptible to growth delays and gastrointestinal issues. By enhancing protein intake, these diets aim to improve overall growth outcomes and support the development of a healthy gut microbiome, essential for nutrient absorption and immune function.

N/A

Waitlist Available

Led By Ariel Salas, MD, MSPH

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postnatal age < 96 hours

Be younger than 18 years old

Must not have

Chromosomal anomalies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years of corrected age

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether giving extremely preterm infants milk with extra protein helps them grow stronger and develop healthier guts compared to regular milk. Some infants will receive milk with extra protein shortly after birth, while others will receive regular milk. Researchers hope to see better growth and gut health in the babies who get the extra protein. Protein supplementation of human milk has been studied to improve growth and development in preterm infants, but results have been mixed.

Who is the study for?

This trial is for extremely preterm infants born at or before 28 weeks of gestation and are less than 96 hours old. It's not suitable for babies with chromosomal anomalies, significant congenital malformations, or those with a terminal illness where medical support would be limited.

What is being tested?

The study is testing if feeding extremely preterm infants a protein-enriched human milk diet versus the usual human milk diet can improve their growth without fat gain and help develop their gut bacteria by the time they reach their due date.

What are the potential side effects?

Since this trial involves dietary changes in very young infants, potential side effects may include digestive issues such as intolerance to the enriched formula, which could affect how well they feed and grow.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby is less than 4 days old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My condition involves chromosomal anomalies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years of corrected age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years of corrected age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years of corrected age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fat-free Mass(FFM)-For-age Z-score

Secondary study objectives

Anthropometric Measurements

Body Fat(BF)-For-age Z-score

Culture-proven Sepsis

+10 more

Other study objectives

Changes in Intestinal Microbiome

Cognitive Outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Protein-enriched human milk dietExperimental Treatment1 Intervention

Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.

Group II: Usual human milk dietActive Control1 Intervention

Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Protein-enriched human milk diets provide additional protein to support the growth and development of preterm infants. This increased protein intake promotes fat-free mass (FFM) and aids in the maturation of the gut microbiome. These mechanisms are crucial for preterm infants, who have higher nutritional needs and immature digestive systems, making them more susceptible to growth delays and gastrointestinal issues. By enhancing protein intake, these diets aim to improve overall growth outcomes and support the development of a healthy gut microbiome, essential for nutrient absorption and immune function.

15N-tracer studies in formula-fed preterm infants: the role of glycine supply in protein turnover.Clinical evaluation of two different protein content formulas fed to full-term healthy infants: a randomized controlled trial.Higher versus lower protein intake in formula-fed low birth weight infants.