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

Onze Lieve Vrouwe Gasthuis

Status: Completed

Conditions: Breast Pumping

Treatments: Device: 15 minutes pumping with INITIATE program; Device: 5 minutes extra pumping with MAINTAIN program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06222567

OLVG040

WO 22.168 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject ≥ 18 years old
• Infant was born maximum 4 (96 hours) days ago
• Subject aims to provide breastmilk for the baby through breastfeeding.
• At least 50% of the milk removal sessions in the last 24hrs were breastfeeds.
• Subject has an clinical indication to pump for reasons
• The subject signs the informed consent documentation

Exclusion criteria

• Woman is exclusively pumping
• Woman is still breastfeeding with the previous child
• Woman has been breastfeeding in the last 6 months

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Pumping individual

Experimental group

Description:

Clinical indication for pumping

Treatment:

Device: 5 minutes extra pumping with MAINTAIN program

Device: 15 minutes pumping with INITIATE program