Human Milk for Premature Infants

(MAGIC Trial)

Recruiting at 3 trial locations

Overseen By Ariel A. Salas, MD, MSPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Necrotizing enterocolitis, Intestinal perforation, Congenital anomalies, others

Compensation: Varies

Number of Visits: 1

Duration: Up to 34 weeks corrected age

486 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how varying amounts of human milk affect the body composition of moderately preterm infants, specifically those born between 27 and 31 weeks of gestation. The study compares two groups: one receiving 180-200 mL/kg/day of human milk and another receiving 140-160 mL/kg/day. Ideal participants are preterm infants who have been fed human milk and reached full feeding levels within the first 14 days after birth. As an unphased trial, this study provides a unique opportunity to enhance understanding of optimal nutrition for preterm 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 human milk diet is safe for premature infants?

Research has shown that using human milk for premature babies is safe and beneficial. Studies have found that feeding these babies with human milk can lower the risk of necrotizing enterocolitis (NEC), particularly in very small infants weighing less than 1250 grams. One study found that using fresh human milk for preterm babies is practical and safe, potentially improving their overall health.

These findings suggest that premature infants tolerate human milk well and can gain important health benefits, making it a safe choice for their nutrition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using human milk for premature infants because it taps into the natural benefits of breast milk, which is uniquely suited to meet the nutritional needs of newborns. Unlike formula, which is a common standard of care, human milk contains antibodies and growth factors that can help strengthen the immune system and support development. The study is exploring different volumes of human milk to see if higher amounts can lead to even better health outcomes for premature infants, potentially reducing complications and improving growth rates. This approach could offer a more natural and potentially more effective option for supporting the health of these vulnerable babies.

What evidence suggests that human milk might be an effective treatment for preterm infants?

Research has shown that breast milk greatly benefits premature babies. Providing a mother's own milk to very small babies in the NICU offers both short- and long-term health advantages. In this trial, participants will receive varying volumes of human milk to assess its impact. Breast milk helps these babies grow better and remain healthier compared to formula. Even if direct breastfeeding is uncommon, the proven benefits of breast milk remain significant. Overall, breast milk supports optimal development for premature babies. ^{2 4 6 7 8}

Who Is on the Research Team?

Ariel A. Salas, MD, MSPH

Principal Investigator

UAB Hospital

Are You a Good Fit for This Trial?

The MAGIC trial is for moderately preterm infants born between 27 and almost 32 weeks of gestation, weighing up to 1500 grams. They must have been fed human milk within the first two weeks after birth and reached full enteral feeding of at least 120 mL/kg/day in that time.

Inclusion Criteria

My pregnancy is between 27 and 31 weeks.

My baby was fed human milk within the first 14 days after birth.

My birthweight was 1500 grams or less.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 180-200 mL/kg/day or 140-160 mL/kg/day of human milk until 34 weeks corrected age

Up to 34 weeks corrected age

Regular monitoring visits for body composition, stool, and breastmilk sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a blood sample at 36 weeks corrected age

Up to 120 days following birth

1 visit for blood sample collection at 36 weeks corrected age

Post-discharge Follow-up

Optional follow-up survey completed by parents at 2-3 years of age to assess cognitive scores and growth outcomes

22-26 months corrected age

What Are the Treatments Tested in This Trial?

Interventions

• Human milk

Trial Overview This study tests the effects of different amounts of human milk (180-200 mL/kg/day) on body composition outcomes in very preterm infants. It's a multi-center trial where participants are randomly assigned to receive varying quantities of milk.

How Is the Trial Designed?

Group I: Intervention: 180-200 mL/kg/day of human milk Experimental Treatment 1 Intervention

Study participants randomized to the intervention group will receive 180-200 mL/kg/day of human milk for 34 weeks corrected age.

Group II: Control:140-160 mL/kg/day of human milk Placebo Group 1 Intervention

Study participants randomized to the control group will receive 140-160 mL/kg/day of human milk for 34 weeks corrected age.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

In a study of 39 premature infants, those who received human milk after discharge experienced significantly fewer days of upper respiratory symptoms at both 1 month and 7 months corrected age compared to those who received only formula.

The findings suggest that human milk ingestion may help reduce infection symptoms in premature infants during their first year of life, highlighting its potential benefits for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human milk reduces outpatient upper respiratory symptoms in premature infants during their first year of life. Blaymore Bier, JA., Oliver, T., Ferguson, A., et al.[2022]

A survey of 72 human milk donors in Sweden revealed that while many women are motivated by a strong desire to help preterm infants, the donation process can be demanding and time-consuming, impacting their ability to care for their own newborns.

To increase the number of human milk donors, it is crucial to provide better information and support from healthcare staff regarding the donation process and the significant benefits of human milk for preterm and sick infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Paying it Forward" - Swedish Women's Experiences of Donating Human Milk. Olsson, E., Diderholm, B., Blomqvist, YT.[2022]

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]

Very preterm infants fed human milk, whether exclusively or mixed with formula, showed slower weight gain and head growth compared to those fed only infant formula, based on a study of 138,703 infants from 777 US NICUs.

Over a 10-year period, the differences in growth outcomes between those fed human milk and those fed formula have decreased, indicating potential improvements in human milk diets or care practices for preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet, weight gain, and head growth in hospitalized US very preterm infants: a 10-year observational study. Belfort, MB., Edwards, EM., Greenberg, LT., et al.[2023]

A quality improvement initiative successfully increased the proportion of very low birth weight (VLBW) infants receiving at least 500 mL of human milk/kg in their first 14 days of life from 50% to 80% within 11 months, and this improvement has been maintained for 4 years.

The program included various supportive measures such as antenatal consultations, education, and a donor milk program, leading to an average intake of 1,111 mL of human milk/kg, highlighting the effectiveness of structured interventions in enhancing feeding practices for VLBW infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The human milk project: a quality improvement initiative to increase human milk consumption in very low birth weight infants. Ward, L., Auer, C., Smith, C., et al.[2012]

A study of 100 raw human milk samples showed that refrigeration at 5°C for 12 hours and freezing at -20°C for 15 days effectively maintained milk acidity and energy content, meeting Brazilian safety regulations.

Over 80% of the milk samples tested were classified as top quality based on acidity levels, indicating that the recommended storage methods ensure both safety and nutritional value for infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the Storage Methods for Raw Human Milk from Mothers with Infants Admitted to a Neonatal Intensive Care Unit, According to Brazilian Regulations. Grazziotin, MC., Grazziotin, AL., Vidal, NM., et al.[2017]

Donor human milk is considered a safe and effective alternative for feeding extremely preterm infants when their mother's milk is not available, supported by clinical data on its benefits.

The article proposes a risk assessment methodology for milk banks worldwide to evaluate and enhance the safety of their processes, ensuring quality control in donor selection and pasteurization techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donor human milk banking and the emergence of milk sharing. Landers, S., Hartmann, BT.[2012]

Breastfeeding is the recommended feeding method for all newborns, including preterm infants, with exclusive breastfeeding advised for the first 6 months for term infants, while preterm infants require fortified human milk to meet their nutritional needs.

The composition of human milk can vary significantly based on factors like lactation duration and storage methods, which can impact its effectiveness for preterm infants, highlighting the need for strategies to optimize its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Milk for Preterm Infants and Fortification. Bhatia, J.[2018]

In a study of 108 human milk samples from 40 mothers, only 12.5% were free from bacterial contamination, highlighting a significant concern for preterm and high-risk neonates.

The most common contaminants were Staphylococcus epidermidis and Acinetobacter, and only 30% of mothers improved their milk contamination levels after receiving counseling on proper collection techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacterial contaminants of collected and frozen human milk used in an intensive care nursery. el-Mohandes, AE., Schatz, V., Keiser, JF., et al.[2019]

Human milk, especially a mother's own milk, significantly reduces the risk of severe health issues in hospitalized neonates, including necrotizing enterocolitis and infections, based on a review of multiple studies.

The timing and amount of human milk are crucial; earlier and larger quantities lead to better health outcomes, and when maternal milk is unavailable, donor human milk is a safer alternative to infant formula.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the Science on the Benefits of Human Milk for Hospitalized, Vulnerable Neonates. Pados, BF.[2023]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9105142/

Efficacy of Donated Milk in Early Nutrition of Preterm Infants Data from Yu et al. [12] showed that formula was significantly superior to donated breast milk in terms of weight gain and body length growth ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378378223001767

Outcomes in very preterm infants receiving an exclusive ... This study compared unfortified pasteurised human donor milk and formula supplements. The principal outcome was survival to 34w postmenstrual age without ...

3. publications.aap.org publications.aap.org/pediatrics/article/148/5/e2021054272/181366/Promoting-Human-Milk-and-Breastfeeding-for-the

Promoting Human Milk and Breastfeeding for the Very Low ... Provision of mother's own milk for hospitalized very low birth weight (VLBW) (≤1500 g) infants in the NICU provides short- and long-term health benefits.

4. nature.com nature.com/articles/s41430-024-01471-3

Clinical assessment of breastfeeding in preterm infants Breastmilk confers empirical benefits for preterm infants, however direct breastfeeding rates in this population remain low.

5. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07597-x

The struggles of breastfeeding mothers of preterm infants This study utilizes the social-ecological system theory to explore reasons for the cessation of breastfeeding among mothers of premature infants in China.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3508468/

Human milk for the premature infant - PMC - PubMed Central A small study demonstrated a decrease in both moderate and severe NEC in small premature infants (birth weight < 1250 g) receiving the “all-human diet.”77 ...

7. nature.com nature.com/articles/s41598-018-37111-7

Testing the feasibility and safety of feeding preterm infants ... Together, these results suggest that the use of fresh human milk in very preterm infants is feasible, safe, and could improve infant outcomes.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2817858

Breast Milk Enema and Meconium Evacuation Among ... Safety outcomes included the incidence of AEs, including retinopathy of prematurity (any stage), intraventricular hemorrhage (grade 2), NEC, ...