Human Milk Cream for Extremely Premature Infants

Not currently recruiting at 7 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Congenital heart disease, Necrotizing enterocolitis, others

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

Compensation: Varies

Number of Visits: 1

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a special cream made from human milk to the diet of extremely premature infants can help them leave the hospital sooner. The focus is on babies at risk of developing bronchopulmonary dysplasia (BPD), a common lung condition in preemies. Researchers aim to determine if these infants grow better and develop well over time with this added cream. Babies weighing between 500 and 1250 grams at birth who can start certain feedings early may be suitable for this study. As an unphased trial, this study offers families a unique opportunity to contribute to groundbreaking research that could improve outcomes for 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.

What prior data suggests that this cream supplement is safe for extremely premature infants?

Research has shown that using human milk cream as a supplement for feeding extremely premature babies is generally safe. In one study, babies who received the cream left the hospital sooner, and no major safety issues emerged. This suggests that the cream is likely well-tolerated.

Another study found that human milk-based nutrient fortifiers, like the cream, may help prevent serious health problems in these very early-born babies. While the research highlights benefits, the absence of reported negative effects indicates good safety.

Overall, although more research is needed, early findings suggest that the human milk cream supplement does not pose significant safety risks for the babies who receive it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard care for extremely premature infants, which typically involves an exclusive human milk (HM)-based diet, the cream supplement being studied adds a human milk-derived cream caloric supplement to this regimen. This supplement is unique because it boosts the caloric intake without introducing foreign substances, potentially aiding in better growth and development for these vulnerable infants. Researchers are excited about this approach because it could offer a more natural and effective way to meet the nutritional needs of extremely premature infants, which is crucial for their early development.

What evidence suggests that the cream supplement could be effective for extremely premature infants?

This trial will compare the effects of a human milk-derived cream supplement with a standard human milk-based diet in extremely premature infants. Studies have shown that very premature babies receiving a cream made from human milk tend to have better outcomes. Specifically, babies given this cream alongside their human milk diet gained weight faster and left the hospital sooner. Research also indicates that these babies grow and develop better after returning home. For those at risk of bronchopulmonary dysplasia, the cream may help shorten their hospital stay. Overall, the cream appears to support healthier growth for these vulnerable babies. ^{1 3 6 7 8}

Who Is on the Research Team?

Amy B Hair, MD

Principal Investigator

Texas Children's Hospital, Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for extremely premature infants with a birth weight between 500-1250g. They must start enteral feeding before day 14 and parenteral nutrition by day 2 of life. Infants already in another nutritional study or with severe health issues like congenital heart disease are not eligible.

Inclusion Criteria

My birth weight was between 500g and 1250g.

My baby started tube feeding before 14 days old and IV nutrition by day 2.

Informed consent obtained from parent or legal guardian prior to reaching 100 ml/kg/day of fortified feeds. Consent should be obtained as soon as possible for eligible infants to collect tracheal aspirates (if intubated) and meconium stool. However, consent must be obtained prior to reaching 100 ml/kg/day of fortified feeds because this is when randomization will occur

Exclusion Criteria

I have a significant birth defect in my heart or another major part of my body.

It's unlikely that you will live through the whole study.

Enrolled in another clinical study affecting nutritional management during the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants receive an exclusive human milk-based diet with or without a cream caloric supplement until discharge or transfer from the medical institution

10 weeks

Weekly anthropometric measurements

Follow-up

Participants are monitored for growth, body composition, and neurodevelopmental outcomes at 18 to 24 months CGA

18-24 months post-discharge

1 outpatient visit

What Are the Treatments Tested in This Trial?

Interventions

• Cream Supplement group

Trial Overview

The trial tests if adding human milk-derived cream to the diet of premature infants can shorten their hospital stay, especially those developing Bronchopulmonary Dysplasia (BPD). It compares standard human milk diets against those supplemented with this cream.

How Is the Trial Designed?

Group I: Cream Supplement group Experimental Treatment 1 Intervention

Infants randomized to the cream supplement group will receive an exclusive HM-based diet with the addition of a HM-derived cream caloric supplement.

Group II: Control Group Active Control 1 Intervention

Infants randomized to the Control group will receive the standard regimen of an exclusive HM-based diet (no cream supplement).

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Akron Children's Hospital

Collaborator

Trials

50

Recruited

5,009,000+

St. John Hospital & Medical Center

Collaborator

Trials

3

Recruited

360+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+

Timpanogos Regional Hospital

Collaborator

Trials

1

Recruited

210+

Orlando Health, Inc.

Collaborator

Trials

32

Recruited

15,100+

St. Louis Children's Hospital

Collaborator

Trials

30

Recruited

83,200+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Baylor Scott and White Health

Collaborator

Trials

18

Recruited

61,200+

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]

Using pasteurized donor human milk (PDHM) instead of formula for preterm infants can significantly reduce the risk of necrotizing enterocolitis, although more randomized control trials are needed to strengthen this evidence.

To ensure the safety and quality of PDHM, human milk banks (HMBs) in Australia are implementing strict standards and risk management systems, which could improve outcomes for preterm infants when supported by strong networks and ongoing research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The knowns and unknowns of human milk banking. Simmer, K.[2011]

Fortified human milk provides premature infants with better growth and nutritional status when fed at about 180 mL/kg/d compared to unfortified human milk.

Feeding fortified human milk may offer significant protection against infections and necrotizing enterocolitis compared to preterm formula, suggesting that neonatal centers should promote its use for premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of human milk fortification for premature infants. Schanler, RJ.[2018]

Fortified human milk significantly supports the growth and nutritional needs of premature infants when fed at approximately 180 mL/kg/day, improving their overall health and development compared to unfortified milk.

Neonatal centers should promote the use of fortified human milk and provide lactation support, as well as encourage skin-to-skin contact to enhance milk production and improve breastfeeding success for premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of human milk and breastfeeding in premature infants. Schanler, RJ., Hurst, NM., Lau, C.[2018]

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The study design is a randomized controlled trial in preterm infants (birth weight 500-1250g) comparing the use of a human milk cream supplement added to an ...

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Extremely premature infants are at risk for slow growth, metabolic abnormalities, and poor neurodevelopmental outcomes. 4. For extremely low‐birth‐weight ...

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We found that preterm infants who received the novel HM-derived cream supplement had a significantly earlier PMA at discharge and trend toward decreased LOS ...

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This study compared unfortified pasteurised human donor milk and formula supplements. The principal outcome was survival to 34w postmenstrual age without ...

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Mortality and severe morbidity remain high in extremely preterm infants. Human milk-based nutrient fortifiers may prevent serious complications and death. We ...

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Eleven infants died during the observation period. The primary outcome was assessed in 105 infants (70%). FFM-for-age z scores did not differ ...