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Trial record 13 of 834 for:    Texas Children's Hospital | ( Map: United States )

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
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Texas Children's Hospital
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

  Show Detailed Description

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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
Study Start Date : July 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2019

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

  2. 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 between cohorts

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

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


Secondary Outcome Measures :
  1. Feeding tolerance [ Time Frame: 6-10 weeks ]
    calculated as the number of days required to reach full enteral feeding volumes of 100 ml/kg/day (for hydration) and 130-160 ml/kg/day (final goal volume for nutrition)

  2. Rates of necrotizing enterocolitis [ Time Frame: 6-10 weeks ]
    the number of patients with a diagnosis of necrotizing enterocolitis will be collected

  3. Rates of spontaneous intestinal perforation [ 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



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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
Texas Children's Hospital
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     History of Changes
Other Study ID Numbers: H-36828
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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