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Clinical Trials/NCT02366780
NCT02366780CompletedNot Applicable

Breast Milk Content Expressed Manually Compared to Electric Pump

Tel-Aviv Sourasky Medical Center1 site in 1 country50 target enrollmentStarted: November 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Macronutrient content of expressed breast milk

Study Overview

Brief Summary

Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive factors for the health and development of infants.Colostrum, which is produced in low quantities for the first 3 to 4 days after birth, is rich in immunologic components and developmental factors.

Breastfeeding difficulties during the first days of life of an infant are common. Moreover, not all infants can be directly fed at the breast.

Therefore, breast milk feeding at this early stage is initiated and promoted by the expression of breast milk either manually or by use of a pump. Whether the method of milk expression at this stage has a qualitative impact on colostrum is currently unknown.

The purpose of this randomized controlled study is to compare the effect of manual expression with electric pump expression upon the macronutrient composition of breast milk.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Healthy lactating mothers of term infants

Exclusion Criteria

  • •HIV infected mothers

Arms & Interventions

Manual expression followed by electric pump

Experimental

Mothers will be assigned to first express breast milk manually followed by electric pump

Intervention: Pump (Procedure)

Electric pump followed by manual expression

Experimental

Mothers will be assigned to first express breast milk by electric pump followed by manual expression

Intervention: Pump (Procedure)

Outcomes

Primary Outcomes

Macronutrient content of expressed breast milk

Time Frame: 3 to 5 min

Mothers will express milk from the same breast indicated in the assigned arm. Macronutrient content will be analyzed using the Human Milk Analyzer

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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