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

Seattle Children's Healthcare System

Status: Enrolling

Conditions: Hirschsprung Disease; Gastrointestinal Complication; Midgut Volvulus; Gastroschisis; Omphalocele; Intestinal Obstruction

Treatments: Dietary Supplement: Exclusive Human Milk; Dietary Supplement: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06072976

STUDY00004330: CGP Milk

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: Under 55 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Exclusive human milk

Experimental group

Description:

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:

Dietary Supplement: Exclusive Human Milk

Standard of care

Experimental group

Description:

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

Treatment:

Dietary Supplement: Standard of Care