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Completed

NCT Number: NCT01167517

Lactation Education Study in Mothers of Very Low Birth Weight Infants

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Instructional digital video disc (DVD)

Other

Breast milk expression instructions provided by digital video disc at the time of hospital discharge

Other names: A Premie Needs His Mother

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Forsyth Medical Center

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2020
First posted
Jul 22, 2010
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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