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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-55
SponsorSeattle Children's Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Standard of Care

    Dietary 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 Milk

    Dietary 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.

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Exclusive human milkExperimental treatment 1 intervention
Group B: Standard of careExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.