Lactation Education Study in Mothers of Very Low Birth Weight Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Wake Forest Baptist Health.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Forsyth Medical Center
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT01167517
First received: July 20, 2010
Last updated: July 21, 2010
Last verified: July 2010
  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

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01167517

Contacts
Contact: Paula M Sisk, PhD 336-718-3277 psisk@wfubmc.edu
Contact: Mary Showalter, IBCLC 336-718-8233 mdshowalter@novanthealth.org

Locations
United States, North Carolina
Forsyth Medical Center Enrolling by invitation
Winston Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest Baptist Health
Forsyth Medical Center
Investigators
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 Baptist Health:
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 October 23, 2014