NCT01802047

Brief Summary

Initiating and sustaining breastfeeding are common challenges in neonatal units. It is known that hindmilk expressed at the end of the expression session has a higher fat content. Previous studies have shown that simultaneous pumping is more effective at producing milk than sequential pumping. However this approach is often felt uncomfortable by the mothers, and sequential pumping is preferred. The purpose of this study is to determine which modality of milk expression by electric pump is the most efficient and productive when sequential pumping is used.This is done by assessing the milk volume expressed per expression and its macronutrients content.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 19, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

4.3 years

First QC Date

February 19, 2013

Last Update Submit

March 27, 2016

Conditions

Prematurity

Keywords

Mothers of PretermsBreastfeeding Mothers of Preterm infantsmother milk feeding

Outcome Measures

Primary Outcomes (1)

  • Daily volume of expressed breast milk under a specific electric pumping modality

    The total volume of all milk expression sessions of the day will be recorded. This, for each 6 days of the study.

    after 15 minutes of electric expression of each breast

Secondary Outcomes (1)

  • Composition of expressed milk under a specific electric pumping modality

    after the first morning session of electric milk expression

Study Arms (1)

Electric Pump Modality

EXPERIMENTAL

Each mother follows all 3 electric pump modalities in a randomized order.

Procedure: milk expression with electric pump

Interventions

milk expression with electric pumpPROCEDURE
Also known as: Medella Electric breast pump
Electric Pump Modality

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mothers of Preterms

You may not qualify if:

  • HIV infected mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neonatology Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Shaul Dollberg, MD

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2013

First Posted

March 1, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

IL(1)