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Dietary Supplement

Breast Milk Feeding for Neonatal Gastrointestinal Complications

N/A

Recruiting

Led By Katie Strobel, MD

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infants with gastroschisis

Infants with intestinal atresia

Must not have

Short gut syndrome

Complicated gastroschisis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 120 days or discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how breast milk and standard food affect babies with gut issues.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves dietary interventions (human milk vs. standard care), side effects may vary widely but could include digestive discomfort or intolerance symptoms depending on individual infant responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My infant was born with organs outside the belly.

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My infant has a blockage in their intestines.

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My infant has a twisted intestine.

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My infant has Hirschsprung's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have short gut syndrome.

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My condition involves a complex form of gastroschisis.

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My baby was born before 34 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 120 days or discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 120 days or discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 days or discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to full feed

Secondary study objectives

Central line infection rate

Concentrations of Antigen-specific immunoglobulins

Gut Microbiome Relative Abundance and Diversity

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of careExperimental Treatment1 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 milkExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of Care

2017

Completed Phase 4

~4420

0 / 7Eligibility criteria met