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Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk

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ClinicalTrials.gov Identifier: NCT02573779
Recruitment Status : Completed
First Posted : October 12, 2015
Results First Posted : April 29, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Amy Hair, Baylor College of Medicine

Brief Summary:
A study to compare growth, development of the intestinal bacterial environment, and other short term outcomes in groups of babies fed primarily their own mother's milk compared to those who receive primarily donor human milk. The investigators hypothesize that infants who receive primarily their own mother's milk will have better growth, a more diverse intestinal bacterial environment, and possibly some improved short term outcomes such as better feeding tolerance and lower rates of infection.

Condition or disease Intervention/treatment
Infant, Very Low Birth Weight Other: Observational - no intervention

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Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intestinal Microbiota and Short Term Outcomes in Very Low Birth Weight Infants Fed Primarily Donor Human Milk Compared to Infants Fed Primarily Mother's Own Milk
Actual Study Start Date : July 10, 2015
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : October 25, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Infants fed mother's own milk
Infants fed >50% mother's own milk with enteral feeding.
Other: Observational - no intervention
This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.

Donor milk fed infants
Infants fed <50% mother's own milk (and thus >50% donor human milk) with enteral feeding.
Other: Observational - no intervention
This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.




Primary Outcome Measures :
  1. Intestinal Microbiome Diversity [ Time Frame: 6 weeks ]
    Stool samples during the first 6 weeks of life will be analyzed to compare development of microbial diversity

  2. Hospital Length of Stay [ Time Frame: Birth to discharge ]
    Hospital length of stay will be calculated from birth to discharge of infant.

  3. Weight Gain [ Time Frame: 6-10 weeks ]
    Weight gain will be evaluated weekly throughout the study (defined as g/kg/day)

  4. Linear Growth [ Time Frame: 6-10 weeks ]
    Linear growth will be measured weekly (defined as cm/week)

  5. Head Circumference Growth [ Time Frame: 6-10 weeks ]
    Growth in head circumference will be measured weekly (defined as cm/wk)


Secondary Outcome Measures :
  1. Days to Final Enteral Feed Volume [ Time Frame: 6-10 weeks ]
    Number of days for infant to reach full enteral feeds.

  2. Rates of Necrotizing Enterocolitis (NEC) [ Time Frame: 6-10 weeks ]
    the number of patients with a diagnosis of NEC (Stage ≥ IIA) will be collected

  3. Rates of Spontaneous Intestinal Perforation (SIP) [ Time Frame: 6-10 weeks ]
    the number of patients who develop a spontaneous intestinal perforation will be collected

  4. Rates of Late-onset Sepsis [ Time Frame: 6-10 weeks ]
    the number of patients with late-onset sepsis will be collected


Biospecimen Retention:   Samples With DNA

At time of initial consent for the study, mothers will also be asked for consent to obtain a small sample (0.2-0.5 mL) of colostrum or expressed milk produced in the first week of life, as well as weekly milk samples thereafter, in order to analyze bacterial content of milk as it compares to the developing infant microbiome. For infants who receive primarily donor milk, weekly samples of the milk they receive may similarly be analyzed for bacterial content.

Infant stool samples will be collected during the first week of life and then at weekly intervals for six weeks. The samples will be analyzed via 16S rRNA sequencing to determine diversity of intestinal microbiota. Additional analysis for metabolomics will be considered if lab availability and cost allows.



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newborn infants less than 1500 g birth weight who are fed primarily either mother's own milk or donor human milk.
Criteria

Inclusion Criteria:

  • Infants less than 72 hours old and less than 1500 g birth weight, who have reasonable expectation of survival and can adhere to a feeding protocol involving mother's own milk and/or donor milk that will include fortification using Prolacta and potentially human cream.

Exclusion Criteria:

  • Exclusion criteria will include birth weight greater than 1500 g, age > 72 hours old, major congenital anomalies, clinically significant heart disease, abdominal wall defects and/or intestinal atresias, severe perinatal hypoxia, or otherwise less than reasonable expectation of survival through the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573779


Locations
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United States, Texas
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Amy Hair, MD Baylor College of Medicine/Texas Children's Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amy Hair, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02573779    
Other Study ID Numbers: H-36828
First Posted: October 12, 2015    Key Record Dates
Results First Posted: April 29, 2020
Last Update Posted: May 21, 2020
Last Verified: May 2020
Keywords provided by Amy Hair, Baylor College of Medicine:
human milk
enteral nutrition
microbiome
microbiota
Additional relevant MeSH terms:
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Body Weight
Birth Weight
Signs and Symptoms