Fortified Donor Breast Milk for Preterm Infants

Overseen By Marianne Garland, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Congenital heart disease, GI diagnoses, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 11 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve the growth of premature infants by comparing two types of nutrient fortification in donor breast milk. Researchers aim to determine if a targeted approach, where nutrients are specifically tailored, leads to better growth than the standard fortification method. The study involves two groups: one receiving standard fortified breast milk and the other receiving targeted fortified milk. Families with premature infants born at or before 30 weeks and weighing less than 1500 grams might find this trial suitable. As an unphased trial, it offers families the opportunity to contribute to important research that could enhance the care of premature infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

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

Research shows that some treatments in this study are safe and well-tolerated by premature babies.

For example, Similac Human Milk Fortifier, when added to breast milk, has been proven to help preterm babies grow and is considered safe. Similac's Liquid Protein Fortifier is also intended for premature infants and is safe with a doctor's guidance.

However, SolCarb is not recommended for premature babies. There isn't enough safety information about SolCarb for preterm infants, and it might cause issues like vomiting and a condition where the body has too much acid.

Nestle Microlipid is generally well-tolerated, but specific information about its use in preterm babies is limited. Still, fat emulsions like those in Microlipid are usually considered safe.

In summary, most treatments are safe with proper medical advice, but SolCarb might not be suitable for premature babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the fortified donor breast milk protocol because it takes a targeted approach to fortifying breast milk for preterm infants, potentially offering better nutrition compared to the standard fortification methods. Unlike the usual practice that uses a one-size-fits-all fortification, this method tailors the nutrient content to the specific needs of each infant, which can be crucial for their growth and development. This personalized approach might improve outcomes for preterm infants, providing them with essential nutrients more effectively and possibly reducing complications associated with prematurity.

What evidence suggests that this trial's treatments could be effective for preterm infants?

This trial will compare standard fortification of breast milk with targeted fortification for preterm infants. Research has shown that adding specific nutrients to donor breast milk can help preterm infants grow better. One study found that preterm babies who received a special liquid human milk fortifier gained more weight in the first 15 days. Nestle Microlipid, part of the targeted fortification in this trial, has helped infants with special dietary needs gain weight. Similac Human Milk Fortifier, which contains broken-down proteins, is designed to meet the higher nutrient needs of premature babies, and studies suggest this can improve growth and digestion. Similac Liquid Protein Fortifier is also used to boost growth in preterm babies. These findings suggest that adding targeted nutrients might be more beneficial than standard methods for helping preterm infants grow. ^{1 3 4 6 7}

Who Is on the Research Team?

Marianne Garland, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for premature infants born at or before 30 weeks and weighing less than or equal to 1500 grams. It's not for those who are very small for their gestational age, have certain heart or gastrointestinal conditions, severe brain hemorrhage, haven't started fortified feeds by 3 weeks old, have necrotizing enterocolitis, or early onset sepsis.

Inclusion Criteria

My birth weight was 1500 grams or less.

My baby was born at or before 30 weeks of pregnancy.

Exclusion Criteria

I have been diagnosed with necrotizing enterocolitis.

Small for gestational age (<3% on Fenton Growth Curve)

Parents do not consent to donor milk

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either standard or targeted fortification of donor breast milk until they reach 34 weeks corrected gestational age

Up to 11 weeks

Follow-up

Participants are monitored for growth metrics such as weight, length, and head circumference

Up to 11 weeks

Long-term follow-up

Participants are monitored for secondary outcomes such as NICU length of stay, mortality rate, and incidence of conditions like NEC and retinopathy of prematurity

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Medica Nutrition SolCarb
• Nestle Microlipid
• Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid
• Similac Liquid Protein Fortifier

Trial Overview The study tests if adding extra nutrients (targeted fortification) to donor breast milk helps preterm babies grow better compared to standard nutrient addition. Babies will be randomly assigned to receive either the standard or targeted fortification.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 5 Interventions

Targeted fortification of breast milk

Group II: Control Experimental Treatment 5 Interventions

Standard fortification of breast milk

Medica Nutrition SolCarb is already approved in European Union, United States for the following indications:

Approved in European Union as SolCarb for:

• Nutritional support for preterm infants

Approved in United States as SolCarb for:

• Nutritional support for preterm infants

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

Both Similac Natural Care (NC) and Enfamil Powder (EP) fortifiers provide essential nutritional support for healthy preterm infants, with no significant differences in overall growth outcomes between the two groups during the study.

However, Enfamil Powder showed a significant decrease in alkaline phosphatase and an increase in calcium levels, likely due to its higher vitamin D content, suggesting the need for monitoring these nutrients when using fortifiers long-term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, controlled evaluation of two commercially available human breast milk fortifiers in healthy preterm neonates. Sankaran, K., Papageorgiou, A., Ninan, A., et al.[2019]

In a study of 164 preterm infants, those fed a nonacidified liquid human milk fortifier experienced significantly greater weight gain in the first 15 days compared to those fed an acidified fortifier, despite both groups showing similar overall weight gain by day 29.

Infants receiving the acidified fortifier had higher rates of feeding intolerance, including more vomiting, gastric residuals, and metabolic acidosis, indicating potential safety concerns with this type of fortifier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial. Schanler, RJ., Groh-Wargo, SL., Barrett-Reis, B., et al.[2019]

The new ultraconcentrated liquid human milk fortifier (LHMF) significantly improved growth metrics, such as weight and length, in preterm infants compared to a traditional powdered human milk fortifier (HMF) over a 28-day study involving 150 infants.

The LHMF was found to be safe, with no increase in the incidence of serious conditions like sepsis or necrotizing enterocolitis, while also providing about 20% more protein than the control HMF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new liquid human milk fortifier and linear growth in preterm infants. Moya, F., Sisk, PM., Walsh, KR., et al.[2012]

In a study of 147 preterm infants, the new concentrated liquid human milk fortifier (LE-HMF) showed noninferior weight gain compared to the standard powdered fortifier (PI-HMF), with both groups achieving excellent weight gain and tolerance.

Infants fed LE-HMF demonstrated significantly greater weight and linear growth over time compared to those fed PI-HMF, indicating that LE-HMF may be a more effective option for promoting growth in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growth and Tolerance of Preterm Infants Fed a New Extensively Hydrolyzed Liquid Human Milk Fortifier. Kim, JH., Chan, G., Schanler, R., et al.[2018]

Fortifying preterm human milk with protein, calcium, and phosphorus significantly improved bone mineral content and growth rates in low birth weight infants compared to unfortified human milk.

The fortified human milk provided growth rates comparable to a special formula for low birth weight infants, although all groups still fell below the 50th percentile for weight at discharge, indicating a need for further nutritional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved bone mineralization and growth in premature infants fed fortified own mother's milk. Greer, FR., McCormick, A.[2019]

In a study examining the stability of vitamins and minerals in the Similac Special Care formula for premature infants, significant reductions in calcium (44-54%), iron (23-34%), and zinc (18-32%) were observed after continuous infusion, indicating that infants may not receive the expected amounts of these nutrients.

In contrast, another formula, Similac 24LBW, showed stable concentrations of all vitamins and minerals tested, suggesting that it may be a more reliable option for ensuring nutrient delivery in premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability of vitamin and mineral concentrations of a low-birth-weight infant formula during continuous enteral feeding. Antonson, DL., Smith, JL., Nelson, RD., et al.[2019]

Infants receiving acidified liquid human milk fortifier (HMF) were significantly more likely to develop metabolic acidosis compared to those receiving powdered HMF, indicating a safety concern with the liquid form.

Despite higher protein intake in the acidified liquid HMF group, there was no difference in growth rates between the two groups, suggesting that the increased protein did not translate to better growth outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of metabolic acidosis with bovine milk-based human milk fortifiers. Cibulskis, CC., Armbrecht, ES.[2021]

Human milk is the best nutrition for both term and preterm infants, but very low birth weight (VLBW) infants often require additional fortification to meet their nutritional needs, particularly for protein, calcium, and phosphate.

The European Milk Bank Association recommends individualized fortification methods, such as Adjustable and Targeted Fortification, to better meet the specific nutrient requirements of VLBW infants, as standard fortification may not provide sufficient protein.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fortification of Human Milk for Preterm Infants: Update and Recommendations of the European Milk Bank Association (EMBA) Working Group on Human Milk Fortification. Arslanoglu, S., Boquien, CY., King, C., et al.[2020]

In a trial involving 39 preterm infants, tailored fortification of human milk did not significantly improve weight gain compared to standard fortification, with average gains of 27.01 g/d and 25.84 g/d respectively.

The study highlighted challenges in implementing targeted fortification in neonatal intensive care units, suggesting that while it is a promising approach, its feasibility may be limited in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Targeted vs. Standard Fortification of Breast Milk on Growth and Development of Preterm Infants (≤32 Weeks): Results from an Interrupted Randomized Controlled Trial. Seliga-Siwecka, J., Fiałkowska, J., Chmielewska, A.[2023]

Citations

1. medica-nutrition.com medica-nutrition.com/solcarb/

SolCarb SolCarb should not be used as a sole source of nutrition. Can SolCarb be used in infants, children and adults? Yes. Do not give SolCarb to premature infants ...

2. researchgate.net researchgate.net/figure/Enteral-feeding-advancement-regimen-prior-to-developing-NEC-SolCarb-was-added-starting_fig2_368481295

Enteral feeding advancement regimen prior to developing ... This report describes the progression of meningitis in a 24-day-old preterm male infant infected with Streptococcus gallolyticus subsp. pasteurianus (SGSP) and ...

3. withpower.com withpower.com/trial/phase-failure-to-thrive-2-2020-d101f

Fortified Donor Breast Milk for Preterm Infants In a study of 164 preterm infants, those fed a nonacidified liquid human milk fortifier experienced significantly greater weight gain in the first 15 days ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7383644/

Preterm Nutrition and Clinical Outcomes - PMC Nearly half (47%) of the infants studied continued losing weight at the time of discharge or death, while only 22% of them regained their birth weight. The mean ...

5. researchgate.net researchgate.net/publication/392538759_Nutritional_Management_for_Preterm_Infants_with_Common_Comorbidities_A_Narrative_Review

Nutritional Management for Preterm Infants with Common ... The complications observed in preterm infants are largely attributable to underdeveloped organ systems and inadequate nutritional stores at ...

6. oregon.gov oregon.gov/oha/ph/healthypeoplefamilies/wic/documents/preterm.pdf

Nutrition Practice Care Guidelines for Preterm Infants in the ... No data on long term benefits or safety. Recommendations. Currently there are no evidence based guidelines regarding dosing for term or pre-term infants .

7. medicaleshop.com medicaleshop.com/solcarb-oral-supplement-tube-feeding-formula?srsltid=AfmBOore7bm3Y5UTKodBrKpZC7vu9uBg3wxbot46QfYaIvPd2mO_Sk3M

SolCarb Oral Supplement Tube Feeding Formula SolCarb should not be used as a sole source of nutrition. Can SolCarb be used in infants, children, and adults? Yes. Do not give SolCarb to premature infants ...