Gastrointestinal Complication, Gastroschisis, Hirschsprung Disease, Intestinal Obstruction, Midgut Volvulus, Omphalocele
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTStandard 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.
DIETARY_SUPPLEMENTExclusive 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.
Sponsors
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 55 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to full feed | From birth to 120 days or until discharge | : 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
| Measure | Time frame | Description |
|---|---|---|
| Central line infection rate | up to 120 days or discharge | 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 | Up to 120 days or 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 | Up to 120 days or discharge | 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 | Up to 120 days or discharge | 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. |
| Concentrations of Antigen-specific immunoglobulins | From birth to 120 days or discharge | To compare total and antigen-specific immunoglobulins in donor milk versus MOM |
Countries
United States
Contacts
CONTACTLeonel Arellano
PRINCIPAL_INVESTIGATORKatie Strobel, MD
Seattle Children's Hospital
Outcome results
None listed