Assessing the Effect of an Additional 5 Minutes Pumping o... | NCT06222567

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

NCT06222567

Sponsor

Onze Lieve Vrouwe Gasthuis

Status

Completed

Last Update Posted

Jan 24, 2025Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Breast Pumping

Interventions

15 minutes pumping with INITIATE program
5 minutes extra pumping with MAINTAIN program

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
WO 22.168	Other Identifier	OLVG

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 6, 2023Actual

Primary Completion Date

Aug 18, 2023Actual

Completion Date

Aug 18, 2023Actual

First Submitted Date

Jan 16, 2024

First Submission Date that Met QC Criteria

Jan 16, 2024

First Posted Date

Jan 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2025

Last Update Posted Date

Jan 24, 2025Actual

Name	Class
Medela AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pumping individual	Experimental	Clinical indication for pumping	Device: 15 minutes pumping with INITIATE program Device: 5 minutes extra pumping with MAINTAIN program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
15 minutes pumping with INITIATE program	Device	15 minutes pumping with INITIATE program	Pumping individual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fedde Scheele, Prof. Dr.	OLVG Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OLVG Hospital		Amsterdam			Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual data is not shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D061186	Breast Milk Expression

Ancestor Terms

ID	Term
D001942	Breast Feeding
D005247	Feeding Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided