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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 120 days or discharge

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to full feed

Secondary outcome measures

Central line infection rate

Concentrations of Antigen-specific immunoglobulins

Gut Microbiome Relative Abundance and Diversity

+2 more

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

304 Previous Clinical Trials

5,217,184 Total Patients Enrolled

Katie Strobel, MDPrincipal InvestigatorSeattle Children's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor open to elderly participants over the age of 85?

"Participants between the ages of 0 days to 55 are eligible for this particular trial. Additionally, there are 10 studies specifically targeting those under 18 and 24 studies that cater to individuals aged 65 or above."

Answered by AI

Am I eligible to join this medical research initiative?

"116 people are being sought for this medical trial, which requires individuals with intestinal obstruction aged between 0 Days and 55."

Answered by AI

How many participants can join this research endeavor?

"Yes, the details posted on clinicaltrials.gov imply that this research is currently seeking participants. The trial was first made available to the public in June 9th 2023 and has been recently updated as of October 3rd 2023. 116 volunteers are required for 1 site location."

Answered by AI

Does the medical trial currently have room for new participants?

"Affirmative. According to clinicaltrials.gov, this medical investigation is presently searching for individuals that meet the specified requirements; it was initially uploaded on June 9th 2023 and has since been revised on October 3rd 2023. 116 volunteers are necessary from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies

Katie 2023. "The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072976.