Clinical trial NCT04006509: Prenatal Breast Pump Education of Mothers and Their Support Person
Official title: Prenatal Breast Pumping Education of Mothers and Their Support Person
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Breast Feeding
Keywords: preterm breast milk
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Compelling evidence exists that breast milk helps protect premature infants from prematurity-specific morbidities, including feeding intolerance, late onset sepsis, and necrotizing enterocolitis. Unfortunately, mothers of VLBW infants often exhibit delayed lactogenesis stage II (when the milk "comes in") and inadequate breast milk production. Earlier initiation of breast milk expression following delivery is associated with increased lactation success. However, lack of nursing time and lack of hospital personal are significant barriers to the early initiation of milk expression in this population. The proposed study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test 1 primary aim and 1 secondary aim. Aim 1: will evaluate the feasibility of antenatal BM pumping education for SPs of mothers of preterm infants. Issues related to recruitment, randomization acceptance of the intervention, and refinement of the education materials and process will be scrutinized. Aim 2 will estimate variability of outcome measurements and effect sizes needed to calculate the sample size for a subsequent larger, adequately powered, randomized clinical trial. Eligible women and their SP will be randomly assigned to one of two groups. Group 1 will receive a prenatally delivered lactation educational program including video recordings, a demonstration of how the pump works and will have a breast pump available in their room. The volume of breast milk produced, timing of lactation stage II, duration of lactation and stress during initial expression will be measured. In addition, breast milk sodium levels will be analyzed on Day 1-7, Day 14 and 21.

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.

Primary outcomes:
measure: Onset of Lactogenesis Stage II Through Volume Attainment
timeFrame: Up to 96 Hours
Secondary outcomes:
measure: Breast Milk Production on Day 1
timeFrame: 0-24 hours postpartum
measure: Time to Breast Pumping Initiation
timeFrame: first 24 hours after delivery
measure: Breast Milk Production Day 2
timeFrame: Day 2 postpartum
measure: Milk Production Day 3
timeFrame: 3 days postpartum
measure: Breast Milk Production Day 4
timeFrame: Day 4 postpartum
measure: Breast Milk Production on Day 5
timeFrame: Day 5 postpartum
measure: Breast Milk Production Day 6
timeFrame: Day 6 postpartum
measure: Breast Milk Production Day 7
timeFrame: Day 7 postpartum
measure: Breast Milk Production Day 14
timeFrame: Day 14 postpartum
measure: Breast Milk Production Day 21
timeFrame: 21 days postpartum
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Leslie A Parker
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parker LA, Bendixen M, Sullivan S, Cacho N, Mueller M. Antepartum Breast Pump Education for Mothers and Their Support Person: Effect on Time to First Expression and Lactation Outcomes-A Randomized Controlled Pilot Study. Breastfeed Med. 2022 May;17(5):437-445. doi: 10.1089/bfm.2021.0275. Epub 2022 Apr 26.