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OpenTrials
Completed

NCT Number: NCT06222567

Assessing the Effect of an Additional 5 Minutes Pumping on Milk Output in the First Days After Delivery

The study hypothesizes that human who are both breastfeeding and pumping in the first days postpartum have more expression volume with an additional 5 minutes of pumping with Maintain program after pumping with the INITIATE program.

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Key information

Conditions

Breast Pumping Behavior Breast Feeding Breast Milk Expression Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OLVG Hospital

Amsterdam, Netherlands

About this study

This study aims to assess if expression milk volume could be improved for patients pumping milk for a clinical indication by implementing five minutes more pumping with the MAINTAIN program, a different sucking pattern, to initiate and benefit milk production. The results of this study will provide important information that validates the proposed changes as well as build clear recommendation for using the Symphony program cards in this population.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject ≥ 18 years old
  • Infant was born maximum 4 (96 hours) days ago
  • Subject has an clinical indication to pump for reasons
  • The subject signs the informed consent documentation

Treatment and study plan

15 minutes pumping with INITIATE program

Device

15 minutes pumping with INITIATE program

5 minutes extra pumping with MAINTAIN program

Device

Additional 5 minutes extra pumping with MAINTAIN program

Primary outcomes

  1. Total expression volume in milliliter

    Time frame: T1= 15 minutes, T2=20 minutes

    Expressed milk volume in milliliters between 15 and 20 minutes of pumping

Secondary outcomes

  1. Total expression volume in milliliters according to postpartum inclusion day (day 1,2,3 or 4) and patient characteristic. Milk yielded in milliliters per minute after 15 and 20 minutes pumping.

    Time frame: T1= 15 minutes, T2=20 minutes

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouwe Gasthuis

Other

Collaborators

  • Medela AG

Registry information

Official study title

Assessing the Effect of Additional 5 Minutes Pumping on Expression Volume in Breastfeeding Human Initiating Breastfeeding.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 24, 2024
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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