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OpenTrials
Completed

NCT Number: NCT06061913

Comparison of Breast Pump Suction Patterns

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Gainesville, Florida, 32504, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pumped milk volume

    Time frame: Days 1-15 post-partum

    Daily volume of milk pumped daily

Secondary outcomes

  1. Maintenance of secretory activation

    Time frame: Days 1-15 post-partum

    Whether sodium level < 20 is maintained

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Medela AG

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2023
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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