Lactation Education Study in Mothers of Very Low Birth Weight Infants

NCT01167517 | Completed

• 2 other identifiers: IRB00013359FMC 2010.0401
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Very Low Birth Weight; Lactation

Keywords

Breast milk; Feeding; Prematurity; Low birth weight infant; Low maternal breast milk feeding

Outcome Measures

Primary Outcomes (2)

• 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.

  Daily during the initial hospitalization which is an average of 60 days

• Volume of daily maternal milk intake in relation to infant weight.

  Daily maternal milk intake(ml)divided by daily infant weight (kilograms).

  Daily during the initial hospitalization which is an average of 60 days

Secondary Outcomes (1)

• Maternal lactation and breast milk expression knowledge.

  One month postpartum

Study Arms (2)

Instructional digital video disc (DVD)

EXPERIMENTAL

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

Other: Instructional digital video disc (DVD)

Instructions in print format

PLACEBO COMPARATOR

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

Other: Instructional digital video disc (DVD)

Interventions

Instructional digital video disc (DVD) OTHER

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

Also known as: A Premie Needs His Mother

Instructional digital video disc (DVD); Instructions in print format

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Non-English speaking
• Illicit drug use during pregnancy

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Forsyth Medical Center: collaborator

Study Sites (1)

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (12)

• 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.

  PMID: 19167553 BACKGROUND

• 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.

  PMID: 16396850 BACKGROUND

• 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.

  PMID: 12517197 BACKGROUND

• 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.

  PMID: 15687416 BACKGROUND

• 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.

  PMID: 10394493 BACKGROUND

• 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.

  PMID: 10353922 BACKGROUND

• 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.

  PMID: 17443195 BACKGROUND

• 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.

  PMID: 18519456 BACKGROUND

• 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.

  PMID: 17908750 BACKGROUND

• 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.

  PMID: 15095795 BACKGROUND

• 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.

  PMID: 17585091 BACKGROUND

• 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.

  PMID: 11146238 BACKGROUND

MeSH Terms

Conditions

Breast Feeding; Premature Birth

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Paula M Sisk, PhD

  Wake Forest Baptist Medical Center/ Forsyth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 22, 2010
• Study Start: July 1, 2010
• Primary Completion: April 9, 2016
• Study Completion: September 30, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-08

Locations

US (1)