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

116 Participants Needed

Trial Summary

What is the purpose of this trial?

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 in infants with intestinal differences.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Exclusive Human Milk, Exclusive Breast Milk, Donor Human Milk, Human Milk Feeding, Standard of Care, Standard Treatment, Conventional Care, Usual Care for neonatal gastrointestinal complications?

Research shows that feeding preterm infants with human milk, including donor milk, can lower the risk of necrotizing enterocolitis (a serious intestinal disease) and improve feeding tolerance, which can lead to shorter hospital stays and better overall outcomes. ^{1 2 3 4 5}

Is feeding donor human milk safe for newborns?

Research shows that donor human milk is safe for feeding premature babies, with safety ensured through careful donor selection, pasteurization, and quality control measures. ^{6 7 8 9 10}

How is the treatment of exclusive human milk unique for neonatal gastrointestinal complications?

Exclusive human milk feeding is unique because it provides essential nutrients and immune protection that can reduce the risk of gastrointestinal complications like necrotizing enterocolitis in newborns, especially those born prematurely. Unlike formula, human milk contains specific proteins and fatty acids that enhance digestion and absorption, and it can be fortified to meet the additional nutritional needs of low-birthweight infants. ^{2 5 7 11 12}

Research Team

Katie Strobel, MD

Principal Investigator

Seattle Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. [2022]

2. Scotland 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Using donor human milk to feed vulnerable term infants: a case series in KwaZulu Natal, South Africa. [2023]

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

Proportionate Postnatal Growth in Preterm Neonates on Expressed Breast Milk Feeding With Selected Fortification. [2021]

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

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

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

Improving the use of human milk during and after the NICU stay. [2021]

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

Use of Donor Human Milk and Maternal Breastfeeding Rates: A Systematic Review. [2022]

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

Donor human milk banking and the emergence of milk sharing. [2012]

9. United States 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. [2017]

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

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

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

Human milk reduces outpatient upper respiratory symptoms in premature infants during their first year of life. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Potential effectiveness of integrating human milk banking and lactation support on neonatal outcomes at Pumwani Maternity Hospital, Kenya. [2023]