Comparison of Breast Pump Suction Patterns

University of Florida

Status: Completed

Conditions: Insufficient Breast Milk Syndrome

Treatments: Behavioral: Breast Pump suction pattern

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06061913

202202805

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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96 participants in 3 patient groups

Breast Pump Suction Pattern 1

Active Comparator group

Treatment:

Behavioral: Breast Pump suction pattern

Breast Pump Suction Pattern 2

Active Comparator group

Treatment:

Behavioral: Breast Pump suction pattern

Breast Pump Suction Pattern 3

Sham Comparator group

Treatment:

Behavioral: Breast Pump suction pattern