Lactation Education Study in Mothers of Very Low Birth Weight Infants
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Infant, Low Birth Weight Lactation |
Other: Instructional digital video disc (DVD) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Prevention |
| Official Title: | Lactation Education Study in Mothers of Very Low Birth Weight Infants |
- Maternal breast milk proportion of enteral feeding. [ Time Frame: Daily during the initial hospitalization which is an average of 60 days ] [ Designated as safety issue: No ]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. [ Time Frame: Daily during the initial hospitalization which is an average of 60 days ] [ Designated as safety issue: No ]Daily maternal milk intake(ml)divided by daily infant weight (kilograms).
- Maternal lactation and breast milk expression knowledge. [ Time Frame: One month postpartum ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Instructional digital video disc (DVD)
Breast milk expression instructions provided by digital video disc at the time of hospital discharge
|
Other: Instructional digital video disc (DVD)
Breast milk expression instructions provided by digital video disc at the time of hospital discharge
Other Name: A Premie Needs His Mother
|
|
Placebo Comparator: Instructions in printe format
Breast milk expression instructions provided in print format at the time of hospital discharge
|
Other: Instructional digital video disc (DVD)
Breast milk expression instructions provided by digital video disc at the time of hospital discharge
Other Name: A Premie Needs His Mother
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Paula M Sisk, PhD | 336-718-3277 | psisk@wfubmc.edu |
| Contact: Mary Showalter, IBCLC | 336-718-8233 | mdshowalter@novanthealth.org |
| United States, North Carolina | |
| Forsyth Medical Center | Enrolling by invitation |
| Winston Salem, North Carolina, United States, 27103 | |
| Principal Investigator: | Paula M Sisk, PhD | Wake Forest Baptist Medical Center/ Forsyth Medical Center |
More Information
Publications:
| Responsible Party: | Paula M. Sisk, PhD/Principal Investigator, Wake Forest University Baptist Medical Center/Forsyth Medical Center |
| ClinicalTrials.gov Identifier: | NCT01167517 History of Changes |
| Other Study ID Numbers: | 00013359, FMC 2010.0401 |
| Study First Received: | July 20, 2010 |
| Last Updated: | July 21, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest University Baptist Medical Center:
|
Breast milk Feeding Prematurity Low birth weight infant Low maternal breast milk feeding |
Additional relevant MeSH terms:
|
Birth Weight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013