Milk in Life Conditions (MiLC): Bacterial Composition of Human Milk Pumped and Stored in "Real-Life" Conditions

NCT ID: NCT03123874

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2017-10-02

Brief Summary

The MiLC trial is a randomized control trial of two different breast pump set-ups: mother's own and sterile. The objective of this trial is to investigate the bacterial composition of human milk pumped and stored in "real-life" conditions. To meet this objective, lactating mothers will fully express breast milk from one breast on two consecutive pumping sessions at home, once with the participant's own pumps and collection kits (own pump set-up) and once with a hospital-grade pump and disposable, sterile collection kits (sterile pump set-up). Randomization will be used to determine which pump participants use first. From the total volume of milk pumped during each pumping session, the researchers will collect 1 oz. Milk from both pumps will be stored at home and sampled on days 0, 2, 4, and 30 after expression for analysis of its bacterial composition.

Detailed Description

Participants will donate 1 oz of human milk during each of two consecutive pumping sessions, for a total volume of 2 oz donated on one day. To collect this human milk, participants will be asked to fully express one breast during each pumping session. Participants will pump once with the participant's own pump set-up and once with the sterile pump set-up (provided by the research team). Women will be randomized to which pump is used first.

Randomization will be done using stratified randomization as follows: participants were stratified by how their infants were fed, namely whether infants were fed human milk only vs. human milk and complementary foods). Then, randomization was conducted within each strata. The researchers aim to have a minimum of 25 participants in each stratum.

All human milk collections will occur at participants' homes between 0700 and 1100 hours. The second pumping session must begin 3 hours (+/-30 minutes) after the beginning of the first pumping session (e.g. the first pumping session at 7:30 am and the second at 10:30 am). Participants will elect from which breast to donate human milk and that breast will be used for both pumping sessions. Participants will be asked not to nurse from or pump that breast during the 2 hours before the first pumping session and not until after the second pumping session (a total of ~5.5 hours).

From the milk produced during each pumping session (which could be up to ~6 oz), researchers will collect 1 oz using a sterile, plastic syringe. Participants will keep the remaining volume of milk. Each ounce of milk collected will be separated into 5 sterile containers (provided). Participants will store donated milk at home until it is picked up by a researcher 2, 4, and 30 days after pumping.

Conditions

Human Milk Microbiome; Bacterial Growth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sterile pump set-up first

Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.

Group Type: EXPERIMENTAL

Sterile pump set-up

Intervention Type: DEVICE

Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).

Mother's Own pump set-up

Intervention Type: DEVICE

Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices).

Mother's Own pump set-up first

Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.

Group Type: EXPERIMENTAL

Sterile pump set-up

Intervention Type: DEVICE

Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).

Mother's Own pump set-up

Intervention Type: DEVICE

Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices).

Interventions

Sterile pump set-up

Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).

Intervention Type: DEVICE

Mother's Own pump set-up

Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Lactating women over the age of 18 years
• Self-reported as healthy women and infants
• Use an electric breast pump
• Confident of ability to donate 1 oz of milk from one breast during each of two consecutive pumping sessions where pumping sessions are 3 hours (+/- 30 minutes) apart and between 0700-1100 hours.
• Able to store donated milk at home for 30 days
• Have infants who do not consume formula or only consume formula episodically as long as the most recent formula-feeding occurred > 2 weeks before the day milk is pumped for this study.

Exclusion Criteria

• Not confident of ability to donate 1 oz of milk from one breast during each of two consecutive pumping sessions, 3 hours (+/- 30 minutes) apart and between the hours of 0700-1100 hours.
• Infant consumption of formula in the past 2 weeks
• Current indication of breast infection (e.g., breast pain, discomfort, lumps, mastitis with fever, red streaks, or hard red portions of the breast)
• Breast pain that the woman does not consider "normal" for lactation/breastfeeding
• Signs/symptoms of acute illness in woman or infant in past 7 days including fever (rectal or temporal temperature ≥99.5 F), dark green nasal discharge, diarrhea (abrupt onset of 3 or more excessively "loose" stools in one day), vomiting (where infant vomiting is not associated with feeding), or severe cough.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Idaho

OTHER

Sponsor Role: collaborator

United States Department of Agriculture (USDA)

FED

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen M. Rasmussen, ScD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Anthony Hay, PhD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Sarah Reyes, MS

Role: STUDY_DIRECTOR

Cornell University

Locations

Hay Laboratory, B75C Wing Hall, Cornell University

Ithaca, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2T32DK007158-42

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NYC-399436

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB #: 1608006566

Identifier Type: -

Identifier Source: org_study_id