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Lactation Education Study in Mothers of Very Low Birth Weight Infants

Primary Purpose

Infant, Very Low Birth Weight, Lactation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Instructional digital video disc (DVD)
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant, Very Low Birth Weight focused on measuring Breast milk, Feeding, Prematurity, Low birth weight infant, Low maternal breast milk feeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Forsyth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Instructional digital video disc (DVD)

Instructions in print format

Arm Description

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

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

Outcomes

Primary Outcome Measures

Maternal breast milk proportion of enteral feeding.
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 maternal milk intake(ml)divided by daily infant weight (kilograms).

Secondary Outcome Measures

Maternal lactation and breast milk expression knowledge.
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.

Full Information

First Posted
July 20, 2010
Last Updated
October 27, 2020
Sponsor
Wake Forest University Health Sciences
Collaborators
Forsyth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01167517
Brief Title
Lactation Education Study in Mothers of Very Low Birth Weight Infants
Official Title
Lactation Education Study in Mothers of Very Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 2010 (Actual)
Primary Completion Date
April 9, 2016 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Forsyth Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Very Low Birth Weight, Lactation
Keywords
Breast milk, Feeding, Prematurity, Low birth weight infant, Low maternal breast milk feeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Instructional digital video disc (DVD)
Arm Type
Experimental
Arm Description
Breast milk expression instructions provided by digital video disc at the time of hospital discharge.
Arm Title
Instructions in print format
Arm Type
Placebo Comparator
Arm Description
Breast milk expression instructions provided in print format at the time of hospital discharge.
Intervention Type
Other
Intervention Name(s)
Instructional digital video disc (DVD)
Other Intervention Name(s)
A Premie Needs His Mother
Intervention Description
Breast milk expression instructions provided by digital video disc at the time of hospital discharge
Primary Outcome Measure Information:
Title
Maternal breast milk proportion of enteral feeding.
Description
Volume (ml) of maternal breast milk received daily by the infant divided by the total daily volume of all enteral feeding received.
Time Frame
Daily during the initial hospitalization which is an average of 60 days
Title
Volume of daily maternal milk intake in relation to infant weight.
Description
Daily maternal milk intake(ml)divided by daily infant weight (kilograms).
Time Frame
Daily during the initial hospitalization which is an average of 60 days
Secondary Outcome Measure Information:
Title
Maternal lactation and breast milk expression knowledge.
Description
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.
Time Frame
One month postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula M Sisk, PhD
Organizational Affiliation
Wake Forest Baptist Medical Center/ Forsyth Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19167553
Citation
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.
Results Reference
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PubMed Identifier
16396850
Citation
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.
Results Reference
background
PubMed Identifier
12517197
Citation
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.
Results Reference
background
PubMed Identifier
15687416
Citation
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.
Results Reference
background
PubMed Identifier
10394493
Citation
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.
Results Reference
background
PubMed Identifier
10353922
Citation
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.
Results Reference
background
PubMed Identifier
17443195
Citation
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. Erratum In: J Perinatol. 2007 Dec;27(12):808.
Results Reference
background
PubMed Identifier
18519456
Citation
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. Erratum In: Pediatrics. 2008 Nov;122(5):1162-3.
Results Reference
background
PubMed Identifier
17908750
Citation
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.
Results Reference
background
PubMed Identifier
15095795
Citation
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.
Results Reference
background
PubMed Identifier
17585091
Citation
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.
Results Reference
background
PubMed Identifier
11146238
Citation
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.
Results Reference
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Lactation Education Study in Mothers of Very Low Birth Weight Infants

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