RecruitingNot ApplicableNCT06072976

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

Sponsor

Seattle Children's Hospital

Enrollment

116 participants

Start Date

Jun 9, 2023

Study Type

INTERVENTIONAL

Conditions

gastroschisis Hirschsprung Disease Gastrointestinal Complication Omphalocele Midgut Volvulus intestinal obstruction

Summary

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.

Eligibility

Min Age: 0 DaysMax Age: 55 Years

Inclusion Criteria1

Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.

Exclusion Criteria6

Infant has already been on feeds
Infants <34 weeks gestation
Parents with contraindications to providing milk (i.e. drug use-cocaine, fentanyl, meth BUT oxy/suboxone/marijuana OK)
Complicated gastroschisis
Short gut syndrome
Additional congenital anomalies that affect ability to tolerate milk (i.e. cyanotic congenital heart disease BUT kidney disease ok)

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Interventions

DIETARY_SUPPLEMENTStandard of Care

Standard of care arm: 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.

DIETARY_SUPPLEMENTExclusive Human Milk

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.