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

NCT06072976 | Recruiting

• 1 other identifier: STUDY00004330: CGP Milk
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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; Midgut Volvulus

Outcome Measures

Primary Outcomes (1)

• 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

  From birth to 120 days or until discharge

Secondary Outcomes (5)

• Central line infection rate

  up to 120 days or discharge

• Portion of parents own milk at time of discharge

  Up to 120 days or discharge

• Gut Microbiome Relative Abundance and Diversity

  Up to 120 days or discharge

• Mother's milk microbiome relative abundance and diversity

  Up to 120 days or discharge

• Concentrations of Antigen-specific immunoglobulins

  From birth to 120 days or discharge

Study Arms (2)

Exclusive human milk

EXPERIMENTAL

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

Standard of care

EXPERIMENTAL

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

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.

Standard of care

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.

Exclusive human milk

Eligibility Criteria

• Age: 0 Days - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.

You may not qualify if:

• Infant has already been on feeds
• Infants \<34 weeks gestation
• Parents with contraindications to providing milk (i.e. drug use-cocaine, fentanyl, meth BUT oxy/suboxone/marijuana OK)
• Complicated gastroschisis
• Short gut syndrome
• Additional congenital anomalies that affect ability to tolerate milk (i.e. cyanotic congenital heart disease BUT kidney disease ok)

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Related Publications (12)

• Varma S, Bartlett EL, Nam L, Shores DR. Use of Breast Milk and Other Feeding Practices Following Gastrointestinal Surgery in Infants. J Pediatr Gastroenterol Nutr. 2019 Feb;68(2):264-271. doi: 10.1097/MPG.0000000000002128.

  PMID: 30119100 BACKGROUND

• Hoban R, Khatri S, Patel A, Unger SL. Supplementation of Mother's Own Milk with Donor Milk in Infants with Gastroschisis or Intestinal Atresia: A Retrospective Study. Nutrients. 2020 Feb 24;12(2):589. doi: 10.3390/nu12020589.

  PMID: 32102333 BACKGROUND

• Bergner EM, Shypailo R, Visuthranukul C, Hagan J, O'Donnell AR, Hawthorne KM, Abrams SA, Hair AB. Growth, Body Composition, and Neurodevelopmental Outcomes at 2 Years Among Preterm Infants Fed an Exclusive Human Milk Diet in the Neonatal Intensive Care Unit: A Pilot Study. Breastfeed Med. 2020 May;15(5):304-311. doi: 10.1089/bfm.2019.0210. Epub 2020 Apr 16.

  PMID: 32298596 BACKGROUND

• Hair AB, Rechtman DJ, Lee ML, Niklas V. Beyond Necrotizing Enterocolitis: Other Clinical Advantages of an Exclusive Human Milk Diet. Breastfeed Med. 2018 Jul/Aug;13(6):408-411. doi: 10.1089/bfm.2017.0192. Epub 2018 Jun 7.

  PMID: 29877722 BACKGROUND

• Murthy S, Parker PR, Gross SJ. Low rate of necrotizing enterocolitis in extremely low birth weight infants using a hospital-based preterm milk bank. J Perinatol. 2019 Jan;39(1):108-114. doi: 10.1038/s41372-018-0235-3. Epub 2018 Oct 5.

  PMID: 30291318 BACKGROUND

• Fleig L, Hagan J, Lee ML, Abrams SA, Hawthorne KM, Hair AB. Growth outcomes of small for gestational age preterm infants before and after implementation of an exclusive human milk-based diet. J Perinatol. 2021 Aug;41(8):1859-1864. doi: 10.1038/s41372-021-01082-x. Epub 2021 May 19.

  PMID: 34012050 BACKGROUND

• Hair AB, Good M. Dilemmas in feeding infants with intestinal failure: a neonatologist's perspective. J Perinatol. 2023 Jan;43(1):114-119. doi: 10.1038/s41372-022-01504-4. Epub 2022 Sep 20.

  PMID: 36127395 BACKGROUND

• Strobel KM, Kramer K, Rottkamp CA, Uy C, Moyer L, Fernandez E, Elashoff D, Sabnis A, and Calkins KL. Implementation of a Nutritional Pathway Across California Hospitals Improves Linear Growth in Neonates with Gastroschisis: A University of California Fetal Consortium Study. Pediatric Academic Societies, 4/22/2022, Denver, CO.

  BACKGROUND

• Hodgson EC, Livingston MH, Robinson T, Farrokhyar F, Walton JM. Use of breast milk in infants with uncomplicated gastroschisis: A retrospective cohort study. J Pediatr Surg. 2022 May;57(5):840-845. doi: 10.1016/j.jpedsurg.2021.12.045. Epub 2022 Jan 13.

  PMID: 35058060 BACKGROUND

• Spatz DL, Robinson AC, Froh EB. Cost and Use of Pasteurized Donor Human Milk at a Children's Hospital. J Obstet Gynecol Neonatal Nurs. 2018 Jul;47(4):583-588. doi: 10.1016/j.jogn.2017.11.004. Epub 2017 Dec 6.

  PMID: 29221672 BACKGROUND

• Kumbhare SV, Jones WD, Fast S, Bonner C, Jong G', Van Domselaar G, Graham M, Narvey M, Azad MB. Source of human milk (mother or donor) is more important than fortifier type (human or bovine) in shaping the preterm infant microbiome. Cell Rep Med. 2022 Sep 20;3(9):100712. doi: 10.1016/j.xcrm.2022.100712. Epub 2022 Aug 26.

  PMID: 36029771 BACKGROUND

• Demers-Mathieu V, Huston RK, Markell AM, McCulley EA, Martin RL, Spooner M, Dallas DC. Differences in Maternal Immunoglobulins within Mother's Own Breast Milk and Donor Breast Milk and across Digestion in Preterm Infants. Nutrients. 2019 Apr 24;11(4):920. doi: 10.3390/nu11040920.

  PMID: 31022910 BACKGROUND

MeSH Terms

Conditions

Intestinal Obstruction; Gastroschisis; Hirschsprung Disease; Hernia, Umbilical; Volvulus Of Midgut

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Digestive System Abnormalities; Megacolon; Colonic Diseases; Infant, Newborn, Diseases; Hernia, Ventral

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Katie Strobel, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonel Arellano

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Katie Strobel, MD

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: October 10, 2023
• Study Start: June 9, 2023
• Primary Completion (Estimated): June 9, 2027
• Study Completion (Estimated): June 9, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)