Lactation Education Study in Mothers of Very Low Birth Weight Infants

Wake Forest University (WFU)

Status: Completed

Conditions: Infant, Very Low Birth Weight; Lactation

Treatments: Other: Instructional digital video disc (DVD)

Study type: Interventional

Funder types: Other

Identifiers

NCT01167517

IRB00013359

FMC 2010.0401 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Instructional digital video disc (DVD)

Experimental group

Description:

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

Treatment:

Other: Instructional digital video disc (DVD)

Instructions in print format

Placebo Comparator group

Description:

Breast milk expression instructions provided in print format at the time of hospital discharge.

Treatment:

Other: Instructional digital video disc (DVD)