Breast Milk Feeding for Neonatal Gastrointestinal Complications

Overseen By Leonel Arellano

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Must not be taking: Cocaine, Fentanyl, Meth

Disqualifiers: Already on feeds, <34 weeks, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 120 days or until discharge

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two feeding methods to assess their impact on feeding success and gut health in infants with certain intestinal conditions. One group will receive only human milk (Exclusive Human Milk), while the other will follow current standard feeding practices (Standard of Care), which may include formula. The trial seeks infants with specific intestinal issues, such as gastroschisis or intestinal atresia, who have not yet started feeding. This unphased trial offers a unique opportunity to contribute to understanding the best feeding practices for infants with these conditions.

Will I have to stop taking my current medications?

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

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

Research has shown that human milk is highly recommended for feeding both premature and full-term babies, often regarded as the healthiest choice. Studies have found that exclusive human milk feeding can lead to better health outcomes, such as a lower risk of movement problems in early childhood, particularly for those born very early. Human milk also aids in developing healthy gut bacteria, crucial for digestion and overall health.

Regarding safety, babies generally tolerate human milk well. No major negative effects have been reported for those fed exclusively with human milk, making it a safe option for newborns. Consequently, many hospitals use donor human milk when a mother's own milk is unavailable.

Overall, exclusive human milk feeding is not only safe but also supports healthier growth and development. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of exclusive human milk feeding for addressing neonatal gastrointestinal complications. Unlike the standard care options, which often involve formula feeding and limited use of donor human milk (DHM), this approach emphasizes the benefits of human milk as the primary nutritional source. Human milk is rich in bioactive compounds that can promote gut health and development, potentially reducing the risk of complications like necrotizing enterocolitis. The study aims to explore how exclusive human milk feeding might offer superior outcomes for infants, especially those requiring surgical interventions, by leveraging the natural properties of human milk to improve recovery and growth.

What evidence suggests that this trial's treatments could be effective for neonatal gastrointestinal complications?

This trial will compare the effects of exclusive human milk feeding with standard care for neonatal gastrointestinal complications. Research has shown that feeding babies only human milk can improve feeding and gut health. Studies have found that preterm babies who receive human milk, either from their mothers or donors, usually tolerate feeding better. Additionally, a diet of only human milk is linked to a lower risk of death in babies with certain intestinal issues. The gut bacteria of babies fed with mother's milk or donor milk also benefit, which is important for overall health. These findings suggest that feeding only human milk might be beneficial for babies with digestive problems. ^{1 2 3 6 7}

Who Is on the Research Team?

Katie Strobel, MD

Principal Investigator

Seattle Children's Hospital

Are You a Good Fit for This Trial?

This trial is for infants with specific intestinal conditions like gastroschisis, omphalocele, and Hirschsprung's disease. It's not open to those who've started feeding, are under 34 weeks gestation, or have complications that prevent milk tolerance.

Inclusion Criteria

My infant was born with organs outside the belly.

My infant has a twisted intestine.

My infant has a blockage in their intestines.

Exclusion Criteria

I have short gut syndrome.

My condition involves a complex form of gastroschisis.

Infant has already been on feeds

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants receive either an exclusive human milk diet or standard feeding practices to assess feeding outcomes and gut microbiome changes

Up to 120 days or until discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment, including central line infection rates and gut microbiome analysis

Up to 120 days or until discharge

What Are the Treatments Tested in This Trial?

Interventions

• Exclusive Human Milk
• Standard of Care

Trial Overview

The study compares the effects of an exclusive human milk diet against standard feeding on the gut microbiome and how quickly infants with congenital gastrointestinal issues can tolerate full feeds.

How Is the Trial Designed?

Group I: Standard of care Experimental Treatment 1 Intervention

Mothers will consent to providing DHM (if qualifies per hospital policy) or formula if MOM is not available. Infants are only eligible to receive donor milk only if 1) MOM is not available 2) if infant initiates feeds before day 3 of age. The donor milk feed would be stopped on day 5 of age. After day five of age, the infant will receive formula if MOM is not available. This is congruent with the current donor milk policy (see Policy #12785). It is highly unlikely given these infants would receive any donor milk because these infants require surgery and often are waiting return of bowel function . The median age of initiation of feeds is 12 days of age for infants with gastroschisis (PMID: 33647253) which exceeds the days of what the hospital policy says for eligibility which is initiates feed before day 3 of age. If the infant does not qualify for any donor milk and MOM is not available, the infant will receive formula

Group II: Exclusive human milk Experimental Treatment 1 Intervention

Mothers will consent to providing DHM if MOM is not available. If the infant reaches 100 ml/kg/day of feeds (one feed advancement prior to full feeds) and MOM remains unavailable, they will transition to formula in preparation for discharge. Infants cannot be discharged on donor milk.

Exclusive Human Milk is already approved in United States, European Union for the following indications:

Approved in United States as Exclusive Human Milk for:

• Nutrition for infants 0-6 months
• Support for gut health in neonates with congenital gastrointestinal pathologies

Approved in European Union as Exclusive Human Milk for:

• Nutrition for infants 0-6 months
• Support for gut health in neonates with congenital gastrointestinal pathologies

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

Published Research Related to This Trial

Feeding premature infants their own mother's human milk in the NICU significantly reduces the risk of serious health issues, highlighting the unique protective components of human milk that are not found in other types of milk.

The timing and amount of human milk given to infants are crucial, with specific periods identified where exclusive or high doses of human milk can greatly improve health outcomes and reduce morbidities associated with prematurity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the use of human milk during and after the NICU stay. Meier, PP., Engstrom, JL., Patel, AL., et al.[2021]

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 can provide therapeutic benefits to infants, but its use should be based on a careful assessment of the benefits versus known risks, which can vary based on donor selection and processing methods.

High ethical standards are essential in the collection and use of donor human milk to ensure the safety of both donors and recipients, and any supplementation should be done cautiously to avoid interfering with maternal breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit by design: Determining the 'value' of donor human milk and medical products derived from human milk in NICU. Hartmann, BT.[2020]

A study of 93 preterm neonates in India showed that those fed an exclusive diet of expressed breast milk (EBM) with appropriate fortification experienced significant and proportionate growth in weight, length, and head circumference during their NICU stay.

The results indicated a mean daily weight gain of 8.8 to 9.5 grams, with weekly increases in length and head circumference, demonstrating the efficacy of EBM and fortification in supporting healthy postnatal growth in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proportionate Postnatal Growth in Preterm Neonates on Expressed Breast Milk Feeding With Selected Fortification. Tewari, VV., Kumar, A., Singhal, A., et al.[2021]

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]

Only 20% of postpartum women surveyed had prior knowledge of human milk banks, highlighting a significant gap in awareness that could impact the acceptance and donation of donor milk, which is crucial for the health of preterm infants.

Despite a supportive attitude towards human milk banks (75.3% in favor), only 28.3% of participants expressed willingness to donate breast milk, primarily due to safety concerns and lack of knowledge about the benefits and processes involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with postpartum women's knowledge, attitude and practice regarding human milk banks and milk donation: A cross-sectional survey. Zhang, N., Li, JY., Liu, XW., et al.[2021]

Human milk provides significant nutritional benefits for low-birthweight (LBW) infants, including improved protein digestion and enhanced gastrointestinal function, which can lead to better overall health outcomes.

Feeding LBW infants human milk can reduce the risk of serious conditions like neonatal infections and necrotizing enterocolitis, but may require supplementation of nutrients like calcium, phosphorus, protein, and sodium to meet their specific needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suitability of human milk for the low-birthweight infant. Schanler, RJ.[2018]

Donor human milk is recommended by the World Health Organization for infant feeding when mother's milk is unavailable, and it has been shown to improve health outcomes in low birthweight infants by reducing serious conditions like necrotising enterocolitis and late onset sepsis.

In a series of seven case studies involving orphaned and abandoned children, many HIV exposed or positive, the use of pasteurized donor human milk showed potential protective effects against failure to thrive, diarrhea, atopic dermatitis, and opportunistic infections, despite limited medical records.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using donor human milk to feed vulnerable term infants: a case series in KwaZulu Natal, South Africa. Reimers, P., Shenker, N., Weaver, G., et al.[2023]

An exclusive human milk (EHM) diet for very low birth weight (VLBW) infants significantly reduced the incidence of necrotizing enterocolitis (NEC), feeding intolerance, and the time to reach full feeds, based on a study of 293 preterm infants.

The EHM diet also resulted in lower total hospitalization costs, saving up to $106,968 per infant, while maintaining similar average daily weight gain compared to other feeding methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. Assad, M., Elliott, MJ., Abraham, JH.[2022]

The introduction of donor human milk (DHM) in neonatal units significantly increased the rates of any breastfeeding at discharge, with a relative risk of 1.19, indicating a positive impact on maternal breastfeeding practices.

However, DHM did not show a significant effect on exclusive maternal breastfeeding rates or the use of the mother's own milk in the first 28 days of life, suggesting that while DHM can support breastfeeding, it may not fully replace the need for maternal milk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Donor Human Milk and Maternal Breastfeeding Rates: A Systematic Review. Williams, T., Nair, H., Simpson, J., et al.[2022]

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]

The establishment of a human milk bank and enhanced lactation support significantly increased the exclusive use of human milk among neonates in a Kenyan hospital, rising from 41.3% to 63.8%.

The intervention also led to a notable reduction in the average duration of stay in the newborn unit by 27%, indicating improved outcomes for vulnerable infants without increasing feeding intolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential effectiveness of integrating human milk banking and lactation support on neonatal outcomes at Pumwani Maternity Hospital, Kenya. Wilunda, C., Israel-Ballard, K., Wanjohi, M., et al.[2023]

Citations

1.

withpower.com

withpower.com/trial/phase-hernia-umbilical-5-2023-3fc9d

Breast Milk Feeding for Neonatal Gastrointestinal ...

This study explores the use of an exclusive human milk diet versus standard feeding practices to compare the influence on feeding outcomes and the gut bacteria ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11064102/

Unlocking the Potential: A Systematic Literature Review on ...

Preterm infants who receive human milk, whether from their biological mothers or through donors, may experience improved feeding tolerance ...

3.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/19345798251384981

Exclusive human milk for infants with gastroschisis

Exclusive human milk was associated with a reduced risk of mortality (RR = 0.38, 95% CI: 0.15–0.99, I2 = 0%). There were no statistically ...

4.

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 ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11977380/

Impact of mother's own milk vs. donor human milk on gut ...

This systematic review focuses on the effects of predominant DHM vs. MOM feeding on the gut microbiota composition in preterm infants.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10114993/

Comparing early life nutritional sources and human milk ...

Many studies have consistently shown that human milk feeding (i.e. breastfeeding) is the strongest predictor of gut microbiota composition in ...

7.

nature.com

nature.com/articles/s41372-025-02296-z

Exclusive human milk diet is associated with lower risk of ...

An EHMD is associated with a decrease in the odds of early childhood motor function impairment among infants born before 32 weeks of gestation.