Comparison of Breast Pump Suction Patterns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Improving Lactation Success in Black Mothers of Critically Ill Infants

NCT05147987

Insufficient Lactation

COMPLETED NA

Improving Lactation Success in Mothers of Critically Infants

NCT04097860

Breast Pumping

COMPLETED NA

Facilitating Lactation Through Optimized Workflows - Evaluating the Efficiency of Pumping Protocols and Cellular Mechanisms of Milk Production

NCT07260968

Low Milk Supply

NOT_YET_RECRUITING NA

Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants

NCT01892085

Breast Milk Expression

COMPLETED NA

Care Based on the Lactation Management Model Provided to Mothers With Babies in the Intensive Care Unit

NCT06125548

Amount of Breast Milk

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insufficient Breast Milk Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Breast Pump Suction Pattern 1

Group Type ACTIVE_COMPARATOR

Breast Pump suction pattern

Intervention Type BEHAVIORAL

Mothers who have reached secretory activation and are pumping \<350 mLs/day will be randomized to one of three breast pump suction patterns.

Breast Pump Suction Pattern 2

Group Type ACTIVE_COMPARATOR

Breast Pump suction pattern

Intervention Type BEHAVIORAL

Mothers who have reached secretory activation and are pumping \<350 mLs/day will be randomized to one of three breast pump suction patterns.

Breast Pump Suction Pattern 3

Group Type SHAM_COMPARATOR

Breast Pump suction pattern

Intervention Type BEHAVIORAL

Mothers who have reached secretory activation and are pumping \<350 mLs/day will be randomized to one of three breast pump suction patterns.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Breast 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes