NCT04006509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2022

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 21, 2024

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

3.5 years

First QC Date

July 1, 2019

Results QC Date

December 4, 2023

Last Update Submit

May 15, 2024

Conditions

Preterm BirthBreast Feeding

Keywords

preterm breast milk

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Breast Milk Production on Day 1

    0-24 hours postpartum

  • Time to Breast Pumping Initiation

    first 24 hours after delivery

  • Breast Milk Production Day 2

    Day 2 postpartum

  • Milk Production Day 3

    3 days postpartum

  • Breast Milk Production Day 4

    Day 4 postpartum

  • +5 more secondary outcomes

Study Arms (2)

Antenatal Education Group

EXPERIMENTAL

Patients will receive a prenatally delivered lactation educational program.

Behavioral: Prenatally Delivered Lactation Educational Program

Standard of Care Group

NO INTERVENTION

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

Interventions

Prenatally Delivered Lactation Educational ProgramBEHAVIORAL

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

Also known as: Antenatal Education
Antenatal Education Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • known illicit maternal drug use
  • history of breast reduction or augmentation
  • positive HIV status
  • infant not expected to live over 2 weeks following delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • 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.

    PMID: 35475721DERIVED

MeSH Terms

Conditions

Premature BirthBreast Feeding

Interventions

Prenatal Education

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Leslie A. Parker
Organization
University of Florida
parkela@ufl.edu
352 273 6384

Study Officials

  • Leslie A Parker

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

November 6, 2018

Primary Completion

May 4, 2022

Study Completion

May 4, 2022

Last Updated

May 21, 2024

Results First Posted

May 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)