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Antenatal Education to Increase Lactation Success

Primary Purpose

Preterm Birth, Breast Feeding

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prenatally Delivered Lactation Educational Program
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring preterm breast milk

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UF Health at the University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Antenatal Education Group

Standard of Care Group

Arm Description

Patients will receive a prenatally delivered lactation educational program.

Patients will receive standard of care and not a prenatally delivered lactation educational program.

Outcomes

Primary Outcome Measures

Onset of Lactogenesis Stage II through maternal report of a sudden breast fullness
Beginning 24 hours after delivery and continuing daily, mothers will be questioned regarding a sudden feeling of breast fullness as an indicator of onset lactogenesis II. Will confirm patient self-reporting by determining whether >100mL of milk is produced per a 24-hour period.

Secondary Outcome Measures

Breast milk production
Daily volume of breast milk produced
Time to breast pumping initiation
Time to mothers beginning to pump breasts after delivery

Full Information

First Posted
July 1, 2019
Last Updated
November 4, 2021
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04006509
Brief Title
Antenatal Education to Increase Lactation Success
Official Title
Antenatal Education of Mothers at Risk for Preterm Delivery and Their Support Person to Enhance Lactation Success
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Breast Feeding
Keywords
preterm breast milk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antenatal Education Group
Arm Type
Experimental
Arm Description
Patients will receive a prenatally delivered lactation educational program.
Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
Patients will receive standard of care and not a prenatally delivered lactation educational program.
Intervention Type
Behavioral
Intervention Name(s)
Prenatally Delivered Lactation Educational Program
Other Intervention Name(s)
Antenatal Education
Intervention Description
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
Primary Outcome Measure Information:
Title
Onset of Lactogenesis Stage II through maternal report of a sudden breast fullness
Description
Beginning 24 hours after delivery and continuing daily, mothers will be questioned regarding a sudden feeling of breast fullness as an indicator of onset lactogenesis II. Will confirm patient self-reporting by determining whether >100mL of milk is produced per a 24-hour period.
Time Frame
Up to 72 Hours
Secondary Outcome Measure Information:
Title
Breast milk production
Description
Daily volume of breast milk produced
Time Frame
three weeks
Title
Time to breast pumping initiation
Description
Time to mothers beginning to pump breasts after delivery
Time Frame
first 24 hours after delivery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie A Parker
Phone
352 215 9360
Email
parkela@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie A Parker
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35475721
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.
Results Reference
derived

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Antenatal Education to Increase Lactation Success

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