Human Milk Cream for Extremely Premature Infants

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

210 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Human Milk Cream for Extremely Premature Infants?

Research shows that adding a human milk-derived cream to the diet of premature infants can help them gain weight as well as those on standard feeding regimens and may lead to earlier hospital discharge. ^{1 2 3 4 5}

Is human milk cream safe for extremely premature infants?

Human milk cream, used as a supplement for premature infants, is generally considered safe. Studies suggest that human milk, including cream supplements, can reduce the risk of certain conditions like necrotizing enterocolitis compared to formula, and human milk banks follow strict safety standards to ensure product safety. ^{1 2 4 6 7}

How does the human milk cream treatment differ from other treatments for premature infants?

The human milk cream treatment is unique because it involves adding a cream derived from human milk to the diet of extremely premature infants, which can improve weight gain and potentially reduce hospital stay compared to standard feeding regimens. This approach focuses on enhancing the nutritional content of an exclusive human milk-based diet, which is different from using formula or bovine-based fortifiers. ^{1 2 8 9 10}

What is the purpose of this trial?

At present, widespread use of the human milk-based caloric supplement (cream) has not occurred, particularly in infants with bronchopulmonary dysplasia (BPD), and further data are needed to support its adoption as a standard care practice. The investigators hypothesize that infants who receive an exclusive human milk (HM)-based diet with the addition of a HM-derived cream caloric supplement (Cream group) will have a shorter length of initial hospital stay compared to infants receiving the standard regimen of an exclusive HM-based diet (Control group). The investigators hypothesize that the effects of the cream caloric supplement will be greater in the subgroup of infants who develop BPD so the relationship will be evaluated between Cream Supplement study group and postmenstrual age (PMA) at discharge and the incidence of BPD. Investigators will also evaluate the post-hospital discharge growth, body composition, and neurodevelopmental outcomes at 18 to 24 months CGA of the infants 500-1250 grams BW who received an exclusive human milk diet including cream supplement or control in the NICU.

Research Team

Amy B Hair, MD

Principal Investigator

Texas Children's Hospital, Baylor College of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

References

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

Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight. [2014]

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

Premature Infants 750-1,250 g Birth Weight Supplemented with a Novel Human Milk-Derived Cream Are Discharged Sooner. [2018]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of Human Milk Feeding and Morbidity in Very Low Birth Weight Infants. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Bovine colostrum as a fortifier to human milk in very preterm infants - A randomized controlled trial (FortiColos). [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. Ireland pubmed.ncbi.nlm.nih.gov

The knowns and unknowns of human milk banking. [2009]

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

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

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

Improving Growth for Infants ≤1250 Grams Receiving an Exclusive Human Milk Diet. [2019]

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

The use of human milk and breastfeeding in premature infants. [2018]