Prenatal Breast Pump Education of Mothers and Their Support Person

Prenatal Breast Pumping Education of Mothers and Their Support Person

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth; Breast Feeding
• Intervention / Treatment: Behavioral: Prenatally Delivered Lactation Educational Program

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health at the University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Antenatal Education Group; Patients will receive a prenatally delivered lactation educational program.	Behavioral: Prenatally Delivered Lactation Educational Program; The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room; Other Names: Antenatal Education
No Intervention: Standard of Care Group; Patients will receive standard of care and not a prenatally delivered lactation educational program.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Leslie A Parker, University of Florida

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2018
• Primary Completion (Actual): May 4, 2022
• Study Completion (Actual): May 4, 2022

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: preterm breast milk
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: P0081761; IRB201400318 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No