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

Prematurity Clinical Trial

Official title:

Milk Volume Production in Mothers of Preterm Infants: Electric Pumping Modalities

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01802047
• Other study ID #: TASMC-13-SD-0678-12-CTIL
• Status: Withdrawn
• Phase: N/A
• First received: February 19, 2013
• Last updated: March 27, 2016
• Start date: August 2013
• Est. completion date: December 2018

Study information

• Verified date: March 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Mothers of Preterms

Exclusion Criteria:

• HIV infected mothers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prematurity

Intervention

Procedure:
• milk expression with electric pump

Locations

Country	Name	City	State
Israel	Department of Neonatology Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Composition of expressed milk under a specific electric pumping modality	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)	after the first morning session of electric milk expression	No