Clinical trial NCT06061913: Comparison of Breast Pump Suction Patterns
Official title: Comparison of Breast Pump Suction Patterns in Achievement of Coming to Volume in Breast Pump-Dependent Mothers of Critically Ill Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insufficient Breast Milk Syndrome
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Medela AG
First posted: 2023-09-29
Enrollment: 274
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pumped milk volume
timeFrame: Days 1-15 post-partum
Secondary outcomes:
measure: Maintenance of secretory activation
timeFrame: Days 1-15 post-partum
measure: Maternal perceptions of comfort, effectiveness, efficiency, and convenience
timeFrame: Day 15 post-partum
measure: Proportion of infant feeds consisting of mother's own milk .
timeFrame: Days 1 post-partum until 6 months .
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Leslie Parker, PhD
role: PRINCIPAL_INVESTIGATOR
References: