Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
Gainesville, Florida, 32504, United States
NCT Number: NCT06061913
Compare effectiveness of breast pump patterns on lactation outcomes of pump dependent mothers of critically ill infants
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Gainesville, Florida, 32504, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mothers who have reached secretory activation and are pumping <350 mLs/day will be randomized to one of three breast pump suction patterns.
Time frame: Days 1-15 post-partum
Daily volume of milk pumped daily
Time frame: Days 1-15 post-partum
Whether sodium level < 20 is maintained
Time frame: Day 15 post-partum
Survey will be used to collect mother's perception of comfort, efficiency, and convenience
Time frame: 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
University of Florida
Other
Comparison of Breast Pump Suction Patterns in Achievement of Coming to Volume in Breast Pump-Dependent Mothers of Critically Ill Infants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06830226
Female Urogenital Diseases and Pregnancy Complications, Insufficient Breast Milk Syndrome
Lisbon, Portugal
View Trial Details