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Impact of Different Electric Pumping Modalities on Milk Volume Production in Mothers of Preterm Infants

This study has been withdrawn prior to enrollment.
(d/t changes in routine modality of milk expression by electric pump.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01802047
First Posted: March 1, 2013
Last Update Posted: March 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
  Purpose

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.


Condition Intervention
Prematurity Procedure: milk expression with electric pump

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Milk Volume Production in Mothers of Preterm Infants: Electric Pumping Modalities

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Daily volume of expressed breast milk under a specific electric pumping modality [ Time Frame: after 15 minutes of electric expression of each breast ]
    The total volume of all milk expression sessions of the day will be recorded. This, for each 6 days of the study.


Secondary Outcome Measures:
  • Composition of expressed milk under a specific electric pumping modality [ Time Frame: after the first morning session of electric milk expression ]
    Fat, Protein and Carbohydrate concentrations will be assessed after each morning session of milk expression by using the mid-infrared milk analyzer (Miris AB, Uppsala, Sweden)


Enrollment: 0
Study Start Date: August 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electric Pump Modality
Each mother follows all 3 electric pump modalities in a randomized order.
Procedure: milk expression with electric pump
Other Name: Medella Electric breast pump

Detailed Description:

The study will last for 6 days. Each mother will express breast milk following two designed modalities in a random fashion, for two days each.

The two designed modalities are:

  1. Complete pumping of one breast (first left) for 15 min, followed by complete pumping of the right breast for 15 min, until the breast is empty.
  2. Pumping both breast simultaneously for 15 min.

At day one of the study, the mothers will follow the standard pumping modality in practice at our department.

In between the two studied procedures at day 4 of the study, the mothers will again follow the standard pumping modality.

On each day of the study, in the morning after the first expression of the day, a sample of 2 ml of pumped breastmilk will be taken, and the total volume of the daily expressed milk will be recorded.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mothers of Preterms

Exclusion Criteria:

  • HIV infected mothers
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802047


Locations
Israel
Department of Neonatology Tel Aviv Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Shaul Dollberg, MD Tel Aviv Medical Center
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01802047     History of Changes
Other Study ID Numbers: TASMC-13-SD-0678-12-CTIL
First Submitted: February 19, 2013
First Posted: March 1, 2013
Last Update Posted: March 29, 2016
Last Verified: March 2016

Keywords provided by Tel-Aviv Sourasky Medical Center:
Mothers of Preterms
Breastfeeding Mothers of Preterm infants
mother milk feeding