Human Milk Fortifier for Growth in Preterm Infants

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

321 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).

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.

What data supports the effectiveness of the treatment Human Milk Fortifier for Growth in Preterm Infants?

Research shows that preterm infants fed with human milk fortified with a new powdered or liquid human milk fortifier tend to have improved growth compared to those receiving standard fortifiers. Studies indicate that these fortifiers, whether in powdered or liquid form, can enhance growth and nutritional status in preterm infants. ^{1 2 3 4 5}

Is human milk fortifier safe for preterm infants?

Research shows that liquid human milk fortifiers are generally safe for preterm infants, with studies evaluating their safety and tolerance. However, data on the safety of prolonged targeted fortification is limited. ^{1 3 4 6 7}

How is the new human milk fortifier treatment different from other treatments for preterm infant growth?

This new human milk fortifier is unique because it is available in both powdered and liquid forms, with some versions having higher protein content than standard options, which may better support the growth of preterm infants. ^{1 2 3 8 9}

Research Team

Elizabeth Reverri, PhD, MS, RD

Principal Investigator

Abbott Nutrition

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Enhanced growth of preterm infants fed a new powdered human milk fortifier: A randomized, controlled trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Human milk fortifier with high versus standard protein content for promoting growth of preterm infants: A meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A new liquid human milk fortifier and linear growth in preterm infants. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of liquid human milk fortifiers: A systematic review and meta-analysis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. [2022]

7. China pubmed.ncbi.nlm.nih.gov

Evidence summary of human milk fortifier in preterm infants. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Novel multinutrient human milk-based human milk fortifier promotes growth and tolerance in premature infants. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Growth in human milk-Fed very low birth weight infants receiving a new human milk fortifier. [2017]