Breast Milk Content Expressed Manually Compared to Electric Pump

Infant Clinical Trial

Official title:

Breast Milk Content Expressed Manually Compared to Electric Pump

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366780
• Other study ID #: SD-0662-11-TLV
• Status: Completed
• Phase: N/A
• First received: February 4, 2015
• Last updated: September 2, 2015
• Start date: November 2012
• Est. completion date: August 2014

Study information

• Verified date: September 2015
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy lactating mothers of term infants

Exclusion Criteria:

• HIV infected mothers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Infant

Intervention

Procedure:
• Pump
Breast milk expression using manually or using an electric pump

Locations

Country	Name	City	State
Israel	Department of Neonatology, Lis Maternity Hospital, Tel Aviv medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Mangel L, Ovental A, Batscha N, Arnon M, Yarkoni I, Dollberg S. Higher Fat Content in Breastmilk Expressed Manually: A Randomized Trial. Breastfeed Med. 2015 Sep;10(7):352-4. doi: 10.1089/bfm.2015.0058. Epub 2015 Jul 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macronutrient content of expressed breast milk	Mothers will express milk from the same breast indicated in the assigned arm. Macronutrient content will be analyzed using the Human Milk Analyzer	3 to 5 min	No