About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Standard of Care
Dietary supplementStandard 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 Milk
Dietary supplementMothers 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 groups
Trial 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
Secondary outcomes
Central line infection rate
To compare rate of central line infections in infants given exclusive human milk versus infants given standard care.
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
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
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.
Sponsors and contacts
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