The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
NCT ID: NCT06072976
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
116 participants
INTERVENTIONAL
2023-06-09
2025-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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)
0 Days
55 Years
ALL
No
Sponsors
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Seattle Children's Hospital
OTHER
Responsible Party
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Katie
Katie Strobel, MD
Principal Investigators
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Katie Strobel, MD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Locations
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Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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STUDY00004330: CGP Milk
Identifier Type: -
Identifier Source: org_study_id
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