Comparison of Breast Pump Suction Patterns

Study Overview
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Brief Summary
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Compare effectiveness of breast pump patterns on lactation outcomes of pump dependent mothers of critically ill infants

Detailed Description
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Insufficient 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 achievement of CTV predicts provision of MOM through to neonatal intensive care unit (NICU) discharge in preterm very low birthweight (VLBW; <1500 g birthweight) 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.

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

Conditions
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Insufficient Breast Milk Syndrome

Intervention / Treatment
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* Behavioral: Breast Pump suction pattern


Participation Criteria
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Eligibility Criteria
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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 UFHealth

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This study will use a randomized control trial design with 3 arms to compare the clinical effectiveness of three different BPSPs 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Breast Pump Suction Pattern 1<br> | Behavioral: Breast Pump suction pattern<br>* Mothers who have reached secretory activation and are pumping <350 mLs/day will be randomized to one of three breast pump suction patterns.<br>|
| Active Comparator: Breast Pump Suction Pattern 2<br> | Behavioral: Breast Pump suction pattern<br>* Mothers who have reached secretory activation and are pumping <350 mLs/day will be randomized to one of three breast pump suction patterns.<br>|
| Sham Comparator: Breast Pump Suction Pattern 3<br> | Behavioral: Breast Pump suction pattern<br>* Mothers who have reached secretory activation and are pumping <350 mLs/day will be randomized to one of three breast pump suction patterns.<br>|

What is the study measuring?
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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 14 days, infant discharge, as well as 3 and 6 months | Days 1 post-partum until 6 months . |