Prenatal Breast Pump Education of Mothers and Their Support Person

Not Applicable

Completed

• Conditions: Breast Feeding; Preterm Birth
• Interventions: Behavioral: Prenatally Delivered Lactation Educational Program

• Registration Number: NCT04006509
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-06
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Primary Completion: 2022-05-04
• Study Completion: 2022-05-04
• Results First Submitted: 2023-12-04
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-15
• Last Update Submitted: 2024-05-15
• Results First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• English speaking
• stated intent to breastfeed
• anticipating the birth of a premature infant < 35 weeks gestation.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antenatal Education Group	Prenatally Delivered Lactation Educational Program	Patients will receive a prenatally delivered lactation educational program.

Primary Outcome Measures

Name	Time	Method
Onset of Lactogenesis Stage II Through Volume Attainment	Up to 96 Hours	Time in hours until mothers pump at least 20 mL of milk in 2 consecutive pumping sessions

Secondary Outcome Measures

Name	Time	Method
Breast Milk Production on Day 1	0-24 hours postpartum	Volume of breast milk produced from 0-24 hours postpartum
Milk Production Day 3	3 days postpartum	Volume of milk produced on Day 3 postpartum
Breast Milk Production Day 4	Day 4 postpartum	Volume of breast milk produced on Day 4 postpartum
Breast Milk Production Day 14	Day 14 postpartum	Volume of breast milk produced on Day 14 postpartum
Breast Milk Production Day 21	21 days postpartum	Volume of breast milk produced on Day 21 postpartum
Time to Breast Pumping Initiation	first 24 hours after delivery	Time to mothers beginning to pump breasts after delivery
Breast Milk Production Day 6	Day 6 postpartum	Volume of breast milk produced on Day 6 postpartum
Breast Milk Production Day 2	Day 2 postpartum	Volume of breast milk produced on day 2 postpartum
Breast Milk Production on Day 5	Day 5 postpartum	Volume of breast milk produced on Day 5 postpartum
Breast Milk Production Day 7	Day 7 postpartum	Volume of milk produced on Day 7 postpartum

Trial Locations

Locations (1)

UF Health at the University of Florida; 🇺🇸 Gainesville, Florida, United States