Comparing breast pump suction patterns for mothers of critically ill infants
Comparison of Breast Pump Suction Patterns in Achievement of Coming to Volume in Breast Pump-Dependent Mothers of Critically Ill Infants
This study is testing which breast pump suction pattern helps mothers of critically ill infants produce more milk after giving birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 274 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06061913 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of different breast pump suction patterns on the lactation outcomes of mothers who are pump dependent for their critically ill infants. It focuses on mothers who have achieved secretory activation but are struggling to produce sufficient milk volumes. The study will randomize 90 participants into three groups, each using a different suction pattern for a duration of seven days. The goal is to determine which suction pattern best facilitates the achievement of adequate milk production by day 14 postpartum.
Who should consider this trial
Good fit: Ideal candidates are mothers over 18 years old who have delivered an infant admitted to the NICU and intend to provide exclusive mother's own milk for the first 14 days postpartum.
Not a fit: Patients who have had breast reduction or augmentation, or whose infants are not expected to survive, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help improve milk production in mothers of critically ill infants, ensuring better nutrition for their babies.
How similar studies have performed: While this approach is innovative, similar studies have not been widely conducted, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gainesville, Florida
- Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Leslie Parker, PhD — University of Florida
- Study coordinator: Leslie A Parker, PhD, APRN
- Email: Parkela@ufl.edu
- Phone: 3522736384
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.