Comparison of Breast Pump Suction Patterns

N/ACompletedNCT06061913

University of Florida96 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Insufficient Breast Milk Syndrome

Interventions

Breast Pump suction patternBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

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

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Pumped milk volume

Daily volume of milk pumped daily

Time frame: Days 1-15 post-partum

Secondary Outcomes

Maintenance of secretory activation

Whether sodium level \< 20 is maintained

Time frame: 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

Time frame: 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

Time frame: Days 1 post-partum until 6 months .

Data from ClinicalTrials.gov

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