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

NCT ID: NCT01802047

Last Updated: 2016-03-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2018-12-31

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.

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.

Conditions

Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Electric Pump Modality

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

Group Type: EXPERIMENTAL

milk expression with electric pump

Intervention Type: PROCEDURE

Interventions

milk expression with electric pump

Intervention Type: PROCEDURE

Other Intervention Names

Medella Electric breast pump

Eligibility Criteria

Inclusion Criteria

• Mothers of Preterms

Exclusion Criteria

• HIV infected mothers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shaul Dollberg, MD

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Locations

Department of Neonatology Tel Aviv Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

TASMC-13-SD-0678-12-CTIL

Identifier Type: -

Identifier Source: org_study_id