Human Milk Fortifier for Growth in Preterm Infants

Not yet recruiting at 13 trial locations

Overseen By Kristen S DeLuca, MS, RDN, LDN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Nutrition

Must not be taking: Systemic steroids, Probiotics, HIV therapy

Disqualifiers: Serious congenital abnormalities, Asphyxia, NEC, Sepsis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well preterm infants grow and tolerate a new human milk fortifier added to their feedings. Researchers compare two different experimental milk fortifiers with a control product, all added to human milk. They seek infants born at or before 32 weeks with a birth weight between 700 and 1500 grams who are already being fed human milk by 21 days of life. Infants meeting these criteria may help improve nutrition options for preterm infants by participating in this trial.

As an unphased trial, this study offers a unique opportunity to advance nutritional care for preterm infants.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications. However, infants receiving systemic steroids or probiotics at the time of randomization are excluded from the study.

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

Research has shown that human milk fortifiers (HMFs) are generally safe for preterm babies. One study found that these fortifiers help preterm babies grow and may even improve their bone health. Another study noted that using commercial HMFs in donor milk was safe and supported growth.

However, caution is necessary. Some data suggests that giving very preterm babies too much protein can be risky. Therefore, while HMFs are helpful, the amount given should be closely monitored.

Overall, HMFs have a good safety record when used properly. Ongoing research aims to ensure they remain safe and effective for preterm infants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for preterm infants because they aim to boost growth by enhancing breast milk with specialized human milk fortifiers. Unlike standard fortifiers, which typically use bovine-based proteins, these new products are derived from human milk, potentially offering a more natural and compatible nutritional boost for fragile infants. This human-derived approach might improve tolerance and nutritional absorption, potentially leading to better growth outcomes compared to traditional methods. By focusing on human milk fortifiers, these treatments could represent a significant advancement in neonatal nutrition, offering hope for improved development in preterm infants.

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

Research shows that adding human milk fortifiers to breast milk can help preterm babies grow better. This trial will compare different human milk fortifiers. Participants in one arm will receive the Experimental Product, a study human milk fortifier added to human milk feedings. In another arm, participants will receive the Control Product, a control human milk fortifier. Studies have found that preterm infants who receive fortified breast milk gain weight and grow in length and head size more quickly while in the hospital. Specifically, one study showed that babies given a particular human milk fortifier experienced better growth, with noticeable weight gain by the sixth week. Another study found that very low birth weight preterm infants grew faster with targeted fortification, gaining about 205.5 grams per week. These findings suggest that using a human milk fortifier can effectively support the growth of preterm infants. ^{4 6 7 8 9}

Who Is on the Research Team?

Elizabeth Reverri, PhD, MS, RD

Principal Investigator

Abbott Nutrition

Are You a Good Fit for This Trial?

This trial is for preterm infants with a birth weight of 700g-1500g, born at ≤32 weeks gestation, and classified as appropriate for their gestational age. They must start human milk feeding by day 21 of life. Only single or twin births qualify, and parents must consent to exclusive human milk fortified with the study product.

Inclusion Criteria

Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study

Parent(s) agrees to allow infant to receive both human milk and study HMF

I am pregnant with one or two babies.

Exclusion Criteria

Participation in another study that has not been approved as a concomitant study by AN

5-minute APGAR ≤ 4

Documentation of maternal use of alcohol or marijuana during pregnancy that in the opinion of the physician is considered abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Preterm infants are fed human milk fortifier (HMF) added to human milk feedings

4 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Hospital Discharge Monitoring

Monitoring of adverse events and growth metrics until hospital discharge

Up to 60 days

What Are the Treatments Tested in This Trial?

Interventions

• Control Product
• Experimental Product

Trial Overview The study tests two types of human milk fortifier (HMF) to see which one supports better growth in preterm infants. It's a double-blind trial meaning neither the researchers nor participants know who gets which HMF, ensuring unbiased results.

How Is the Trial Designed?

Group I: Product 2 Experimental Treatment 1 Intervention

Study Human Milk Fortifier added to human milk feedings

Group II: Product 1 Experimental Treatment 1 Intervention

Study Human Milk Fortifier added to human milk feedings

Group III: Control Product Active Control 1 Intervention

Control Human Milk Fortifier added to human milk feedings

Who Is Running the Clinical Trial?

Abbott Nutrition

Lead Sponsor

Trials

173

Recruited

33,700+

Robert B. Ford

Abbott Nutrition

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Melissa Brotz

Abbott Nutrition

Chief Marketing Officer

Bachelor's degree in Journalism from Northwestern University

Published Research Related to This Trial

In a study of 144 preterm infants, those receiving a new powdered human milk fortifier (SF) showed significantly greater weight gain and length growth compared to those receiving a commercial fortifier (CF), with weight gain differences of 2.6 g/kg/day in the intent-to-treat analysis.

The new fortifier (SF) was well-tolerated and led to faster growth milestones, with infants reaching 1800 g weight at an earlier time (SDAY 18) compared to those on the CF (SDAY 25), indicating its potential as a superior nutritional supplement for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced growth of preterm infants fed a new powdered human milk fortifier: A randomized, controlled trial. Reis, BB., Hall, RT., Schanler, RJ., 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]

Liquid human milk fortifiers (HMFs) made from whey or casein hydrolysate may promote better growth in very low-birth-weight (VLBW) infants compared to powder HMFs, with evidence suggesting greater linear growth and weight gain.

However, there is insufficient evidence to conclude that these HMFs impact the incidence of necrotizing enterocolitis (NEC) or late-onset sepsis, highlighting the need for more robust studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of liquid human milk fortifiers: A systematic review and meta-analysis. Bridges, KM., Newkirk, M., Byham-Gray, L., et al.[2021]

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]

Targeted fortification of human milk significantly improved growth rates in very low birth weight preterm infants, with weekly weight gain averaging 205.5 g compared to 155 g in those receiving standard fortification.

The study found no gastrointestinal or metabolic intolerance in infants receiving targeted fortification, indicating it is a safe method for enhancing nutrition in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. Morlacchi, L., Mallardi, D., Giannì, ML., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7268980/

Multi‐nutrient fortification of human milk for preterm infants Key results: Preterm infants who were fed fortified breast milk put on weight and grew in length and head size a little more quickly while they were in‐hospital ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02307760?term=RENAISSANCE%202&rank=9

Evaluation of Human Milk Fortifiers in Preterm Infants In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11913907/

Comparative Growth Outcomes in Very Low Birth Weight ... Of 112 infants analyzed, Group 2 supplemented with HMF showed superior growth outcomes by 6th wk/discharge of intervention, with mean weight of ...

4. withpower.com withpower.com/trial/phase-growth-10-2022-181e6

Human Milk Fortifier for Growth in Preterm Infants Targeted fortification of human milk significantly improved growth rates in very low birth weight preterm infants, with weekly weight gain averaging 205.5 g ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1744165X25000289

Human milk for preterm infants This showed that human milk‐based fortifier did not decrease NEC (RR 0.95, 95 % CI 0.2 to 4.5), feed intolerance, late‐onset sepsis, or death, or improve ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02307760

Evaluation of Human Milk Fortifiers in Preterm Infants It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8649601/

Evidence summary of human milk fortifier in preterm infants This study summarized the best evidence for human milk fortifier in preterm infants. Medical staff should assess the specific clinical conditions and parental ...

8. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/10.1002/jpen.2558

Osmolality of fortified donor human milk: An experimental study Commercial human milk fortifiers (HMFs) appear to be well tolerated, support preterm infant growth, and may increase bone mineralization and ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04478487

Novel Human Milk Based Human Milk Fortifier (MHMHMF) Donor milk fed infants had lower weight gain than infants fed either moms own milk or preterm formula possibly because of lower nutrient content of donor milk.