Comparison of Breast Pump Suction Patterns

September 2, 2025 updated by: University of Florida

Comparison of Breast Pump Suction Patterns in Achievement of Coming to Volume in Breast Pump-Dependent Mothers of Critically Ill Infants

Compare effectiveness of breast pump patterns on lactation outcomes of pump dependent mothers of critically ill infants

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Insufficient Mothers Own Milk (MOM) has its origins during the first 14 days postpartum, a critical window that includes secretory activation (SA; milk coming in; lactogenesis II) and the achievement of coming to volume (CTV; providing 500 mLs/day of MOM by day 14 postpartum). For all lactating mothers, SA must be achieved for lactation to continue, and CTV predicts provision of MOM through to neonatal intensive care unit (NICU) discharge in preterm very low birth weight (VLBW; <1500 g birth weight) infants. For this study, we posit that alternate breast pump suction patterns (BPSP; suction rate, intensity, and rhythm) may facilitate achievement of CTV in mothers who have achieved SA, but whose daily pumped MOM volumes indicate a high risk of not achieving CTV. Therefore, the overall objective of this study is to compare the clinical effectiveness of three different breast pump suction patterns on lactation outcomes, including achievement of SA, among pump dependent mothers of critically ill infants who demonstrate faltering lactation after achievement of SA. At 6-8 days postpartum, 90 pump dependent mothers of critically ill infants who have achieved SA but demonstrate faltering lactation (<350 mLs/day pumped MOM volume), will be randomized to use one of three different BPSPs with two groups having alternative BPSPs and one group using the current practice standard for 7 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Leslie A Parker, PhD, APRN
  • Phone Number: 3522736384
  • Email: Parkela@ufl.edu

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32504
        • Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • > 18 years of age
  • delivered an infant admitted to the NICU
  • Intent to provide exclusive mother's own milk to their infants for the first 14 days postpartum
  • Expect to be breast pump dependent for the first 14 days postpartum

Exclusion Criteria:

  • Breast reduction or augmentation
  • Infant not expected to survive
  • Medications or maternal conditions incompatible with providing mother's own milk to a NICU infant
  • Resides over 60 miles from University of Florida (UFHealth) in Gainesville, FL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Breast Pump Suction Pattern 1
Behavioral: Breast Pump suction pattern
Mothers who have reached secretory activation and are pumping <350 mLs/day will be randomized to one of three breast pump suction patterns.
Active Comparator: Breast Pump Suction Pattern 2
Behavioral: Breast Pump suction pattern
Mothers who have reached secretory activation and are pumping <350 mLs/day will be randomized to one of three breast pump suction patterns.
Sham Comparator: Breast Pump Suction Pattern 3
Behavioral: Breast Pump suction pattern
Mothers who have reached secretory activation and are pumping <350 mLs/day will be randomized to one of three breast pump suction patterns.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pumped milk volume
Time Frame: Days 1-15 post-partum
Daily volume of milk pumped daily
Days 1-15 post-partum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maintenance of secretory activation
Time Frame: Days 1-15 post-partum
Whether sodium level < 20 is maintained
Days 1-15 post-partum
Maternal perceptions of comfort, effectiveness, efficiency, and convenience
Time Frame: Day 15 post-partum
Survey will be used to collect mother's perception of comfort, efficiency, and convenience
Day 15 post-partum
Proportion of infant feeds consisting of mother's own milk .
Time Frame: Days 1 post-partum until 6 months .
Proportion of feeds consisting of mother's own milk for first 15 days, infant discharge, as well as 3 and 6 months
Days 1 post-partum until 6 months .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medela AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leslie Parker, PHD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202202805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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