Breast Milk Content Expressed Manually Compared to Electric Pump
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 4, 2015
CompletedFirst Posted
Study publicly available on registry
February 19, 2015
CompletedSeptember 3, 2015
September 1, 2015
1.7 years
February 4, 2015
September 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Manual expression followed by electric pump
EXPERIMENTALMothers will be assigned to first express breast milk manually followed by electric pump
Electric pump followed by manual expression
EXPERIMENTALMothers will be assigned to first express breast milk by electric pump followed by manual expression
Interventions
Breast milk expression using manually or using an electric pump
Eligibility Criteria
You may qualify if:
- Healthy lactating mothers of term infants
You may not qualify if:
- HIV infected mothers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neonatology, Lis Maternity Hospital, Tel Aviv medical Center
Tel Aviv, 64239, Israel
Related 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.
PMID: 26171639RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shaul Dolberg, MD
Department of Pediatrics, Sakler Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2015
First Posted
February 19, 2015
Study Start
November 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
September 3, 2015
Record last verified: 2015-09