Lactation Education Study in Mothers of Very Low Birth Weight Infants

Not Applicable

Completed

• Conditions: Lactation; Infant, Very Low Birth Weight
• Interventions: Other: Instructional digital video disc (DVD)

• Registration Number: NCT01167517
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Primary Completion: 2016-04-09
• Status Verified: 2020-08
• Study Completion: 2020-09-30
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Instructional digital video disc (DVD)	Instructional digital video disc (DVD)	Breast milk expression instructions provided by digital video disc at the time of hospital discharge.
Instructions in print format	Instructional digital video disc (DVD)	Breast milk expression instructions provided in print format at the time of hospital discharge.

Primary Outcome Measures

Name	Time	Method
Maternal breast milk proportion of enteral feeding.	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.
Volume of daily maternal milk intake in relation to infant weight.	Daily during the initial hospitalization which is an average of 60 days	Daily maternal milk intake(ml)divided by daily infant weight (kilograms).

Secondary Outcome Measures

Name	Time	Method
Maternal lactation and breast milk expression knowledge.	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.

Trial Locations

Locations (1)

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States