Insufficient Breast Milk Syndrome
Conditions
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.
Interventions
BEHAVIORALBreast Pump suction pattern
Mothers who have reached secretory activation and are pumping \<350 mLs/day will be randomized to one of three breast pump suction patterns.
Sponsors
Medela AG
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pumped milk volume | Days 1-15 post-partum | Daily volume of milk pumped daily |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of secretory activation | Days 1-15 post-partum | Whether sodium level \< 20 is maintained |
| Maternal perceptions of comfort, effectiveness, efficiency, and convenience | Day 15 post-partum | Survey will be used to collect mother's perception of comfort, efficiency, and convenience |
| Proportion of infant feeds consisting of mother's own milk . | 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 |
Countries
United States
Outcome results
None listed