NCT06222567

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 16, 2024

Last Update Submit

January 21, 2025

Conditions

Breast Pumping

Outcome Measures

Primary Outcomes (1)

  • Total expression volume in milliliter

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

    T1= 15 minutes, T2=20 minutes

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.

    T1= 15 minutes, T2=20 minutes

Study Arms (1)

Pumping individual

EXPERIMENTAL

Clinical indication for pumping

Device: 15 minutes pumping with INITIATE programDevice: 5 minutes extra pumping with MAINTAIN program

Interventions

15 minutes pumping with INITIATE programDEVICE

15 minutes pumping with INITIATE program

Pumping individual
5 minutes extra pumping with MAINTAIN programDEVICE

Additional 5 minutes extra pumping with MAINTAIN program

Pumping individual

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OLVG Hospital

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehavior

Study Officials

  • Fedde Scheele, Prof. Dr.

    OLVG Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 24, 2024

Study Start

February 6, 2023

Primary Completion

August 18, 2023

Study Completion

August 18, 2023

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Individual data is not shared

Locations

NL(1)