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

NCT02573779 | Completed Results

• 1 other identifier: H-36828
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 2

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.

Conditions

Infant, Very Low Birth Weight

Keywords

human milk; enteral nutrition; microbiome; microbiota

Outcome Measures

Primary Outcomes (5)

• Intestinal Microbiome Diversity

  Stool samples during the first 6 weeks of life will be analyzed to compare development of microbial diversity

  6 weeks

• Hospital Length of Stay

  Hospital length of stay will be calculated from birth to discharge of infant.

  Birth to discharge

• Weight Gain

  Weight gain will be evaluated weekly throughout the study (defined as g/kg/day)

  6-10 weeks

• Linear Growth

  Linear growth will be measured weekly (defined as cm/week)

  6-10 weeks

• Head Circumference Growth

  Growth in head circumference will be measured weekly (defined as cm/wk)

  6-10 weeks

Secondary Outcomes (4)

• Days to Final Enteral Feed Volume

  6-10 weeks

• Rates of Necrotizing Enterocolitis (NEC)

  6-10 weeks

• Rates of Spontaneous Intestinal Perforation (SIP)

  6-10 weeks

• Rates of Late-onset Sepsis

  6-10 weeks

Study Arms (2)

Infants fed mother's own milk

Infants fed \>50% mother's own milk with enteral feeding.

Other: Observational - no intervention

Donor milk fed infants

Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.

Other: Observational - no intervention

Interventions

Observational - no intervention OTHER

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 mother's own milk

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (2)

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (29)

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• Bjorkstrom MV, Hall L, Soderlund S, Hakansson EG, Hakansson S, Domellof M. Intestinal flora in very low-birth weight infants. Acta Paediatr. 2009 Nov;98(11):1762-7. doi: 10.1111/j.1651-2227.2009.01471.x. Epub 2009 Aug 8.

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• Ford SL, Lohmann P, Preidis GA, Gordon PS, O'Donnell A, Hagan J, Venkatachalam A, Balderas M, Luna RA, Hair AB. Improved feeding tolerance and growth are linked to increased gut microbial community diversity in very-low-birth-weight infants fed mother's own milk compared with donor breast milk. Am J Clin Nutr. 2019 Apr 1;109(4):1088-1097. doi: 10.1093/ajcn/nqz006.

  PMID: 30982856 DERIVED

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.

Results Point of Contact

• Title: Dr. Amy B. Hair
• Organization: Baylor College of Medicine/Texas Children's Hospital

abhair@bcm.tmc.edu

832-826-1398

Study Officials

• Amy Hair, MD

  Baylor College of Medicine - Texas Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 12, 2015
• Study Start: July 10, 2015
• Primary Completion: September 30, 2016
• Study Completion: October 25, 2018
• Last Updated: February 25, 2025
• Results First Posted: April 29, 2020

Record last verified: 2025-02

Locations

US (2)