An interventional study of Standard of Care and Exclusive Human Milk in Gastrointestinal Complication, Intestinal Obstruction and Gastroschisis, sponsored by Seattle Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 0 Days to 55 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Supportive care
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.
104 studies on the registry are indexed under Intestinal Obstruction; 15 are open to participants now.
This study's planned enrollment of 116 is above the median of 62 across 54 interventional studies indexed under Intestinal Obstruction.
Browse Intestinal Obstruction studies →Seattle Children's Hospital is the lead sponsor of 215 studies on the registry; 44 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Exclusive Human Milk
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
Dietary Supplement: Standard 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.
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.
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
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
Time frame: From birth to 120 days or discharge
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