Lactation Education Study in Mothers of Very Low Birth Weight Infants
NCT ID: NCT01167517
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2010-07-31
2020-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Instructional digital video disc (DVD)
Breast milk expression instructions provided by digital video disc at the time of hospital discharge.
Instructional digital video disc (DVD)
Breast milk expression instructions provided by digital video disc at the time of hospital discharge
Instructions in print format
Breast milk expression instructions provided in print format at the time of hospital discharge.
Instructional digital video disc (DVD)
Breast milk expression instructions provided by digital video disc at the time of hospital discharge
Interventions
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Instructional digital video disc (DVD)
Breast milk expression instructions provided by digital video disc at the time of hospital discharge
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Maternal educational attainment less than/equal to 12 years
* Maternal low income status (Medicaid participant prior to delivery)
Exclusion Criteria
* Illicit drug use during pregnancy
18 Years
FEMALE
No
Sponsors
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Forsyth Medical Center
OTHER
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Paula M Sisk, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest Baptist Medical Center/ Forsyth Medical Center
Locations
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Forsyth Medical Center
Winston-Salem, North Carolina, United States
Countries
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References
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Ong J, Miller PS, Appleby R, Allegretto R, Gawlinski A. Effect of a preoperative instructional digital video disc on patient knowledge and preparedness for engaging in postoperative care activities. Nurs Clin North Am. 2009 Mar;44(1):103-15, xii. doi: 10.1016/j.cnur.2008.10.014.
Sisk PM, Lovelady CA, Dillard RG, Gruber KJ. Lactation counseling for mothers of very low birth weight infants: effect on maternal anxiety and infant intake of human milk. Pediatrics. 2006 Jan;117(1):e67-75. doi: 10.1542/peds.2005-0267.
Furman L, Taylor G, Minich N, Hack M. The effect of maternal milk on neonatal morbidity of very low-birth-weight infants. Arch Pediatr Adolesc Med. 2003 Jan;157(1):66-71. doi: 10.1001/archpedi.157.1.66.
Ronnestad A, Abrahamsen TG, Medbo S, Reigstad H, Lossius K, Kaaresen PI, Egeland T, Engelund IE, Irgens LM, Markestad T. Late-onset septicemia in a Norwegian national cohort of extremely premature infants receiving very early full human milk feeding. Pediatrics. 2005 Mar;115(3):e269-76. doi: 10.1542/peds.2004-1833. Epub 2005 Feb 1.
Schanler RJ, Hurst NM, Lau C. The use of human milk and breastfeeding in premature infants. Clin Perinatol. 1999 Jun;26(2):379-98, vii.
Schanler RJ, Shulman RJ, Lau C. Feeding strategies for premature infants: beneficial outcomes of feeding fortified human milk versus preterm formula. Pediatrics. 1999 Jun;103(6 Pt 1):1150-7. doi: 10.1542/peds.103.6.1150.
Sisk PM, Lovelady CA, Dillard RG, Gruber KJ, O'Shea TM. Early human milk feeding is associated with a lower risk of necrotizing enterocolitis in very low birth weight infants. J Perinatol. 2007 Jul;27(7):428-33. doi: 10.1038/sj.jp.7211758. Epub 2007 Apr 19.
Sisk PM, Lovelady CA, Gruber KJ, Dillard RG, O'Shea TM. Human milk consumption and full enteral feeding among infants who weigh </= 1250 grams. Pediatrics. 2008 Jun;121(6):e1528-33. doi: 10.1542/peds.2007-2110.
Vohr BR, Poindexter BB, Dusick AM, McKinley LT, Higgins RD, Langer JC, Poole WK; National Institute of Child Health and Human Development National Research Network. Persistent beneficial effects of breast milk ingested in the neonatal intensive care unit on outcomes of extremely low birth weight infants at 30 months of age. Pediatrics. 2007 Oct;120(4):e953-9. doi: 10.1542/peds.2006-3227.
Meier PP, Engstrom JL, Mingolelli SS, Miracle DJ, Kiesling S. The Rush Mothers' Milk Club: breastfeeding interventions for mothers with very-low-birth-weight infants. J Obstet Gynecol Neonatal Nurs. 2004 Mar-Apr;33(2):164-74. doi: 10.1177/0884217504263280.
Jones E, Spencer SA. Optimising the provision of human milk for preterm infants. Arch Dis Child Fetal Neonatal Ed. 2007 Jul;92(4):F236-8. doi: 10.1136/adc.2006.100941.
Killersreiter B, Grimmer I, Buhrer C, Dudenhausen JW, Obladen M. Early cessation of breast milk feeding in very low birthweight infants. Early Hum Dev. 2001 Jan;60(3):193-205. doi: 10.1016/s0378-3782(00)00116-x.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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FMC 2010.0401
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00013359
Identifier Type: -
Identifier Source: org_study_id