Breast Milk Content Expressed Manually Compared to Electric Pump

NCT ID: NCT02366780

Last Updated: 2015-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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Manual expression followed by electric pump

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

Group Type EXPERIMENTAL

Pump

Intervention Type PROCEDURE

Breast milk expression using manually or using an electric pump

Electric pump followed by manual expression

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

Group Type EXPERIMENTAL

Pump

Intervention Type PROCEDURE

Breast milk expression using manually or using an electric pump

Interventions

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Pump

Breast milk expression using manually or using an electric pump

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy lactating mothers of term infants

Exclusion Criteria

* HIV infected mothers
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaul Dolberg, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Sakler Faculty of Medicine

Locations

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Department of Neonatology, Lis Maternity Hospital, Tel Aviv medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type RESULT
PMID: 26171639 (View on PubMed)

Other Identifiers

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SD-0662-11-TLV

Identifier Type: -

Identifier Source: org_study_id

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