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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01802047
First received: February 19, 2013
Last updated: August 20, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Milk Volume Production in Mothers of Preterm Infants: Electric Pumping Modalities

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 250
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mothers of Preterms

Exclusion Criteria:

  • HIV infected mothers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802047

Contacts
Contact: Shaul Dollberg, MD +9723692590 dollberg@tasmc.health.gov.il

Locations
Israel
Department of Neonatology Tel Aviv Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Shaul Dollberg, MD Tel Aviv Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01802047     History of Changes
Other Study ID Numbers: TASMC-13-SD-0678-12-CTIL
Study First Received: February 19, 2013
Last Updated: August 20, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014