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Antenatal Education

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04006509
Recruitment Status : Recruiting
First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Preterm Birth Breast Feeding Behavioral: Prenatally Delivered Lactation Educational Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 6, 2018
Estimated Primary Completion Date : November 6, 2019
Estimated Study Completion Date : June 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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 Name: Antenatal Education

No Intervention: Standard of Care Group
Patients will receive standard of care and not a prenatally delivered lactation educational program.

Primary Outcome Measures :
  1. Onset of Lactogenesis Stage II [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04006509

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Contact: Leslie A Parker 352 215 9360

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United States, Florida
UF Health at the University of Florida Recruiting
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
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Principal Investigator: Leslie A Parker University of Florida

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Responsible Party: University of Florida Identifier: NCT04006509     History of Changes
Other Study ID Numbers: P0081761
IRB201400318 ( Other Identifier: University of Florida )
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications