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

Seattle Children's Hospital116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

116

Conditions

Gastrointestinal Complication Intestinal Obstruction Gastroschisis Hirschsprung Disease Omphalocele Midgut Volvulus

Interventions

Standard of CareDIETARY_SUPPLEMENT

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.

Exclusive Human MilkDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 0 DaysMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease. Exclusion Criteria: 1. Infant has already been on feeds 2. Infants \<34 weeks gestation 3. Parents with contraindications to providing milk (i.e. drug use-cocaine, fentanyl, meth BUT oxy/suboxone/marijuana OK) 4. Complicated gastroschisis 5. Short gut syndrome 6. Additional congenital anomalies that affect ability to tolerate milk (i.e. cyanotic congenital heart disease BUT kidney disease ok)

Locations (1)

Seattle Children's Hospital

Seattle, Washington, United States

RECRUITING

Outcomes

Primary Outcomes

Time to full feed

: In infants with congenital gastrointestinal pathologies (gastroschisis, giant omphalocele, atresia, midgut volvulus, Hirschsprung disease, CGP), to determine if use of an exclusive human milk diet will decrease the number of days to full feeding volume (120 ml/kg/day) (29 subjects per power calculation) compared to human milk/formula

Time frame: From birth to 120 days or until discharge

Secondary Outcomes

Central line infection rate

To compare rate of central line infections in infants given exclusive human milk versus infants given standard care.

Time frame: up to 120 days or discharge

Portion of parents own milk at time of discharge

: To compare proportion of parents providing any/exclusive mother's own milk (MOM) at discharge in infants given exclusive human milk arm versus standard care arm

Time frame: Up to 120 days or discharge

Gut Microbiome Relative Abundance and Diversity

To examine if utilization of donor milk when mother's own milk is insufficient alters the infant's gut microbiome alpha diversity and beta diversity and bacterial relative abundances

Time frame: Up to 120 days or discharge

Mother's milk microbiome relative abundance and diversity

To discern how mother's own milk microbiome differs from donor milk microbiome relative abundances and diversity. We will examine how the milk microbiomes influences the infant's gut microbiome and time to full feeds.

Time frame: Up to 120 days or discharge

Concentrations of Antigen-specific immunoglobulins

To compare total and antigen-specific immunoglobulins in donor milk versus MOM

Central Contacts

Leonel Arellano

CONTACT

915-443-4390 leonel.arellano@seattlechildrens.org

Data from ClinicalTrials.gov

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