Lactation Education Study in Mothers of Very Low Birth Weight Infants

October 27, 2020 updated by: Wake Forest University Health Sciences
This study will test the effectiveness of breast milk expression discharge instructions in digital video disc (DVD) format for home use by mothers of very low birth weight infants on the dose and duration of mother's breast milk feeding in their infants compared to breast milk expression discharge instructions in printed format. The investigators hypothesize that infants whose mothers receive breast milk expression discharge instructions via DVD will receive a larger dose of maternal breast milk and for longer duration during the initial neonatal intensive care unit hospitalization than infants whose mothers receive discharge instructions in printed format.

Study Overview

Detailed Description

Very low birth weight (VLBW; <1500 g) infants who receive maternal breast milk, as opposed to infant formula, are less likely to experience the serious illnesses and poor developmental outcomes associated with VLBW. However, a disparity exists in breast milk feeding. Infants whose mothers have low educational attainment and low income are less likely to receive maternal breast milk than infants whose mothers who do not have low educational attainment and low income. The primary objective of this proposed research is to determine the effect of lactation discharge instructions in an audio-visual format provided to mothers for home viewing on the dose and duration of maternal breast milk received by their VLBW infants during the neonatal intensive care unit hospitalization.

Methods. Forty mothers of VLBW infants will be randomly assigned to receive a breast milk expression instruction digital video disc (DVD) in addition to standard of care lactation education or assigned to receive written instructions in addition to standard of care lactation education. In addition to comparing infant intake of maternal breast milk intake, pre and post intervention lactation and breast milk expression knowledge will be compared between groups and DVD viewing frequency and acceptability will be determined with a log and questionnaire to be completed by the intervention group and collected the first month after delivery.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Infant birth weight less than 1500 grams
  • Maternal educational attainment less than/equal to 12 years
  • Maternal low income status (Medicaid participant prior to delivery)

Exclusion Criteria:

  • Non-English speaking
  • Illicit drug use during pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Instructional digital video disc (DVD)
Breast milk expression instructions provided by digital video disc at the time of hospital discharge.
Breast milk expression instructions provided by digital video disc at the time of hospital discharge
Other Names:
  • A Premie Needs His Mother
Placebo Comparator: Instructions in print format
Breast milk expression instructions provided in print format at the time of hospital discharge.
Breast milk expression instructions provided by digital video disc at the time of hospital discharge
Other Names:
  • A Premie Needs His Mother

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal breast milk proportion of enteral feeding.
Time Frame: Daily during the initial hospitalization which is an average of 60 days
Volume (ml) of maternal breast milk received daily by the infant divided by the total daily volume of all enteral feeding received.
Daily during the initial hospitalization which is an average of 60 days
Volume of daily maternal milk intake in relation to infant weight.
Time Frame: Daily during the initial hospitalization which is an average of 60 days
Daily maternal milk intake(ml)divided by daily infant weight (kilograms).
Daily during the initial hospitalization which is an average of 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal lactation and breast milk expression knowledge.
Time Frame: One month postpartum
Prior knowledge will be assessed by administering a self-administered knowledge test on lactation and breast milk expression before providing the instructional DVD or written instructions. The same test will be self-administered approximately one month after delivery.
One month postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Paula M Sisk, PhD, Wake Forest Baptist Medical Center/ Forsyth Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2010

Primary Completion (Actual)

April 9, 2016

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

July 20, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (Estimate)

July 22, 2010

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00013359
  • FMC 2010.0401 (Other Identifier: Forsyth Medical Center)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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