Clincosm LogoSign in Get a demo

Antenatal Education to Increase Lactation Success

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT04006509
Collaborator
(none)
280
Enrollment
1
Location
2
Arms
41.8
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Prenatally Delivered Lactation Educational Program
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Antenatal Education of Mothers at Risk for Preterm Delivery and Their Support Person to Enhance Lactation Success
Actual Study Start Date :
Nov 6, 2018
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Onset of Lactogenesis Stage II through maternal report of a sudden breast fullness [Up to 72 Hours]

      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

    1. Breast milk production [three weeks]

      Daily volume of breast milk produced

    2. Time to breast pumping initiation [first 24 hours after delivery]

      Time to mothers beginning to pump breasts after delivery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UF Health at the University of Florida Gainesville Florida United States 32610

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Leslie A Parker, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT04006509
    Other Study ID Numbers:
    • P0081761
    • IRB201400318
    First Posted:
    Jul 5, 2019
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Florida
    preterm breast milk
    Additional relevant MeSH terms:
    Premature Birth

    Study Results

    No Results Posted as of Nov 5, 2021