Insufficient Breast Milk SyndromeNCT06061913
Comparison of Breast Pump Suction Patterns
A study testing Breast Pump suction pattern in people with Insufficient Breast Milk Syndrome, run by University of Florida at 1 site in United States.
Trial summary
Compare effectiveness of breast pump patterns on lactation outcomes of pump dependent mothers of critically ill infants Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insufficient Breast Milk Syndrome
- What is being tested?
- Breast Pump suction pattern
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
Gainesville, Florida, 32504
About this study
Official title: 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
Read the 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.
- Conditions
- Insufficient Breast Milk Syndrome
- Being tested
- Breast Pump suction pattern
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Pump suction patternBehavioural
Mothers who have reached secretory activation and are pumping <350 mLs/day will be randomized to one of three breast pump suction patterns.
| Study group | Role | What they receive |
|---|---|---|
| Breast Pump Suction Pattern 1 | Active comparator | Not described Receives: Behavioral: Breast Pump suction pattern |
| Breast Pump Suction Pattern 2 | Active comparator | Not described Receives: Behavioral: Breast Pump suction pattern |
| Breast Pump Suction Pattern 3 | Sham comparator | Not described Receives: Behavioral: Breast Pump suction pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pumped milk volume
Daily volume of milk pumped daily
Measured: Days 1-15 post-partum
Secondary outcomes (3)
Maintenance of secretory activation
Whether sodium level < 20 is maintained
Measured: Days 1-15 post-partum
Maternal perceptions of comfort, effectiveness, efficiency, and convenience
Survey will be used to collect mother's perception of comfort, efficiency, and convenience
Measured: Day 15 post-partum
Proportion of infant feeds consisting of mother's own milk .
Proportion of feeds consisting of mother's own milk for first 15 days, infant discharge, as well as 3 and 6 months
Measured: Days 1 post-partum until 6 months .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Apr 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficient Breast Milk SyndromeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study will use a randomized control trial design with 3 arms to compare the clinical effectiveness of three different breast pump suction patterns (BPSP) on lactation outcomes among pump dependent mothers of critically ill infants who demonstrate faltering lactation on day 6-8 postpartum. Mothers identified as having faltering lactation will be randomly assigned to one of 3 groups; (1) BPSP1, (2) BPSP 2, and (3) Standard BPSP.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Medela AG
- Responsible party
- Sponsor
- Investigators
- Leslie Parker, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061913
- Sponsor's protocol ID
- 202202805
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Breast Pump Suction Patterns in Achievement of Coming to Volume in Breast Pump-Dependent Mothers of Critically Ill Infants
- ClinicalTrials.gov ID
- NCT06061913
- Acronym / sponsor ID
- 202202805
- Conditions
- Insufficient Breast Milk Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Medela AG
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare effectiveness of breast pump patterns on lactation outcomes of pump dependent mothers of critically ill infants
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study will use a randomized control trial design with 3 arms to compare the clinical effectiveness of three different breast pump suction patterns (BPSP) on lactation outcomes among pump dependent mothers of critically ill infants who demonstrate faltering lactation on day 6-8 postpartum. Mothers identified as having faltering lactation will be randomly assigned to one of 3 groups; (1) BPSP1, (2) BPSP 2, and (3) Standard BPSP.
| Arm | Type | Receives |
|---|---|---|
| Breast Pump Suction Pattern 1 | Active comparator | Behavioral: Breast Pump suction pattern |
| Breast Pump Suction Pattern 2 | Active comparator | Behavioral: Breast Pump suction pattern |
| Breast Pump Suction Pattern 3 | Sham comparator | Behavioral: Breast Pump suction pattern |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Pump suction patternMothers who have reached secretory activation and are pumping <350 mLs/day will be randomized to one of three breast pump suction patterns. | Behavioural | Breast Pump Suction Pattern 1, Breast Pump Suction Pattern 2, Breast Pump Suction Pattern 3 |
Primary outcome
Pumped milk volume
Time frame: Days 1-15 post-partum
Daily volume of milk pumped daily
3 secondary outcomes
Maintenance of secretory activation
Time frame: Days 1-15 post-partum
Maternal perceptions of comfort, effectiveness, efficiency, and convenience
Time frame: Day 15 post-partum
Proportion of infant feeds consisting of mother's own milk .
Time frame: Days 1 post-partum until 6 months .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Insufficient Breast Milk Syndrome
Enrolling by invitationObservational study
Domperidone on the Composition of Preterm Breastmilk Using a Human Milk Mid-infrared Spectroscopy Analyzer
Insufficient Breast Milk Syndrome, Premature Birth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Parker, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Pump suction pattern in people with Insufficient Breast Milk Syndrome, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pumped milk volume (time frame: Days 1-15 post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.