Back to resultsThe Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
Primary Purpose
Gastrointestinal Complication, Intestinal Obstruction, Gastroschisis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care
Exclusive Human Milk
Sponsored by
About this trial
This is an interventional supportive care trial for Gastrointestinal Complication
Eligibility Criteria
Inclusion Criteria: Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease. Exclusion Criteria: 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)
Sites / Locations
- Seattle Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Exclusive human milk
Standard of care
Arm 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.
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Central line infection rate
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
: 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
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
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
To compare total and antigen-specific immunoglobulins in donor milk versus MOM
Full Information
NCT ID
NCT06072976
First Posted
August 8, 2023
Last Updated
October 3, 2023
Sponsor
Seattle Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06072976
Brief Title
The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
Official Title
The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
June 9, 2025 (Anticipated)
Study Completion Date
June 9, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Complication, Intestinal Obstruction, Gastroschisis, Hirschsprung Disease, Omphalocele, Midgut Volvulus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exclusive human milk
Arm Type
Experimental
Arm 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.
Arm Title
Standard of care
Arm Type
Experimental
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard of Care
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Exclusive Human Milk
Intervention 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.
Primary Outcome Measure Information:
Title
Time to full feed
Description
: 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
Time Frame
From birth to 120 days or until discharge
Secondary Outcome Measure Information:
Title
Central line infection rate
Description
To compare rate of central line infections in infants given exclusive human milk versus infants given standard care.
Time Frame
up to 120 days or discharge
Title
Portion of parents own milk at time of discharge
Description
: 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
Time Frame
Up to 120 days or discharge
Title
Gut Microbiome Relative Abundance and Diversity
Description
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
Time Frame
Up to 120 days or discharge
Title
Mother's milk microbiome relative abundance and diversity
Description
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.
Time Frame
Up to 120 days or discharge
Title
Concentrations of Antigen-specific immunoglobulins
Description
To compare total and antigen-specific immunoglobulins in donor milk versus MOM
Time Frame
From birth to 120 days or discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants with gastroschisis, giant omphalocele, intestinal atresia, mid-gut volvulus, hirschsprungs disease.
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonel Arellano
Phone
915-443-4390
Email
leonel.arellano@seattlechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie Strobel, MD
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Strobel, MD
Phone
262-623-1987
Email
katie.strobel@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Leonel Arellano
Phone
915-443-4390
Email
leonel.arellano@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Patrick Javid, MD
First Name & Middle Initial & Last Name & Degree
Katie Strobel, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
30119100
Citation
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.
Results Reference
background
PubMed Identifier
32102333
Citation
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.
Results Reference
background
PubMed Identifier
32298596
Citation
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.
Results Reference
background
PubMed Identifier
29877722
Citation
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.
Results Reference
background
PubMed Identifier
30291318
Citation
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.
Results Reference
background
PubMed Identifier
34012050
Citation
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.
Results Reference
background
PubMed Identifier
36127395
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
35058060
Citation
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.
Results Reference
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PubMed Identifier
29221672
Citation
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.
Results Reference
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PubMed Identifier
36029771
Citation
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.
Results Reference
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PubMed Identifier
31022910
Citation
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.
Results Reference
background
Learn more about this trial
The Influence of Feeding Source on the Gut Microbiome and Time to Full Feeds in Neonates With Congenital Gastrointestinal Pathologies
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