Comparison of Breast Pump Suction Patterns

NCT06061913 | Completed

• 1 other identifier: 202202805
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insufficient Breast Milk Syndrome

Outcome Measures

Primary Outcomes (1)

• Pumped milk volume

  Daily volume of milk pumped daily

  Days 1-15 post-partum

Secondary Outcomes (3)

• Maintenance of secretory activation

  Days 1-15 post-partum

• Maternal perceptions of comfort, effectiveness, efficiency, and convenience

  Day 15 post-partum

• Proportion of infant feeds consisting of mother's own milk .

  Days 1 post-partum until 6 months .

Study Arms (3)

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

Interventions

Breast Pump suction pattern BEHAVIORAL

Mothers who have reached secretory activation and are pumping \<350 mLs/day will be randomized to one of three breast pump suction patterns.

Breast Pump Suction Pattern 1; Breast Pump Suction Pattern 2; Breast Pump Suction Pattern 3

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must be able to bear children and produce breast milk.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Medela AG: collaborator

Study Sites (1)

Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida

Gainesville, Florida, 32504, United States

Location

Study Officials

• Leslie Parker, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: September 29, 2023
• Study Start: April 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)