N/A
N=74
Prenatal Breast Pump Education of Mothers and Their Support Person
Preterm Birth · Breast Feeding
Bottom Line
View on ClinicalTrials.gov: NCT04006509 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Onset of Lactogenesis Stage II Through Volume Attainment — 84.8; 81 hours — p=0.985
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prenatally Delivered Lactation Educational Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Onset of Lactogenesis Stage II Through Volume Attainment |
84.8; 81 | 0.985 |
| SECONDARY Breast Milk Production on Day 1 |
15.3; 24.3 | 0.539 |
| SECONDARY Time to Breast Pumping Initiation |
4; 3.8 | 0.959 |
| SECONDARY Breast Milk Production Day 2 |
32.7; 39.5 | 0.743 |
| SECONDARY Milk Production Day 3 |
55.88; 59.7 | 0.886 |
| SECONDARY Breast Milk Production Day 4 |
101.8; 97.4 | 0.107 |
| SECONDARY Breast Milk Production on Day 5 |
149.9; 138.5 | 0.687 |
| SECONDARY Breast Milk Production Day 6 |
245.3; 266.8 | 0.871 |
| SECONDARY Breast Milk Production Day 7 |
345; 361.9 | 0.376 |
| SECONDARY Breast Milk Production Day 14 |
431; 428 | 0.770 |
| SECONDARY Breast Milk Production Day 21 |
725; 573.9 | 0.237 |
Summary
The study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test whether antenatal education of the support person of mothers may decrease time to initiation of breast pumping, decrease time to lactogenesis stage II and increase breast milk production.
Eligibility Criteria
Inclusion Criteria
- English speaking
- stated intent to breastfeed
- anticipating the birth of a premature infant < 35 weeks gestation.
Exclusion Criteria
- known illicit maternal drug use
- history of breast reduction or augmentation
- positive HIV status
- infant not expected to live over 2 weeks following delivery.
Data sourced from ClinicalTrials.gov (NCT04006509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.