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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Seattle Children's Hospital
Study ID
NCT06072976
Status
Recruiting
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Conditions

  • Gastrointestinal Complication
  • Gastroschisis
  • Hirschsprung Disease
  • Intestinal Obstruction
  • Midgut Volvulus
  • Omphalocele

Eligibility Criteria

Sex
ALL
Age
0 Days - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 9, 2023
Status verified
Apr 2026
Primary completion
Jun 9, 2027
Completion
Jun 9, 2027

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Exclusive 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.
  • Experimental: Standard of care
    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

Primary Outcome Measure

Time to full feed [ Time Frame: From birth to 120 days or until discharge ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Children's HospitalSeattleWashington98105
Katie Strobel, MD
[email protected]
262-623-1987
Leonel Arellano
[email protected]
915-443-4390
Patrick Javid, MD (SUB_INVESTIGATOR)
Katie Strobel, MD (PRINCIPAL_INVESTIGATOR)

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