Recruiting

Observational Study

Sponsor:

Seattle Children's Hospital

Code:

NCT06072976

Conditions

Gastrointestinal Complication

Intestinal Obstruction

Gastroschisis

Hirschsprung Disease

Omphalocele

Eligibility Criteria

Sex: All

Age: 0 - 55

Healthy Volunteers: Not accepted

Interventions

Standard of Care

Exclusive Human Milk

Study Details

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.

Conditions

Gastrointestinal Complication

Intestinal Obstruction

Gastroschisis

Hirschsprung Disease

Omphalocele

Study ID

NCT06072976

Start date

Jun 9, 2023

Status verified date

Apr, 2026

Completion date

Jun 9, 2027

Anticipated

Primary completion date

Jun 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 55

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Leonel Arellano

915-443-4390leonel.arellano@seattlechildrens.org

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Katie Strobel, MD

262-623-1987katie.strobel@seattlechildrens.org

Leonel Arellano

915-443-4390leonel.arellano@seattlechildrens.org

Principal Investigator:

Katie Strobel, MD

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2026-04-30.