Comparison of Breast Pump Suction Patterns

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: Completed
• Conditions: Insufficient Breast Milk Syndrome
• Intervention / Treatment: Behavioral: Breast Pump suction pattern

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: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pumped milk volume	Daily volume of milk pumped daily	Days 1-15 post-partum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of secretory activation	Whether sodium level < 20 is maintained	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	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	Days 1 post-partum until 6 months .

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Medela AG
• Investigators: Principal Investigator: Leslie Parker, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID 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