Lactation Education Study in Mothers of Very Low Birth Weight Infants

Infant, Very Low Birth Weight Clinical Trial

Official title:

Lactation Education Study in Mothers of Very Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167517
• Other study ID #: IRB00013359
• Secondary ID: FMC 2010.0401
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2020
• Est. primary completion date: April 9, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Infant, Very Low Birth Weight
• Lactation

Intervention

Other:
• Instructional digital video disc (DVD)
Breast milk expression instructions provided by digital video disc at the time of hospital discharge

Locations

Country	Name	City	State
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Forsyth Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. Review. — View Citation

Killersreiter B, Grimmer I, Bührer 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. — View 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. — View 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. — View Citation

Rønnestad A, Abrahamsen TG, Medbø 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. Epub 2005 Feb 1. — View 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. Review. — View 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. — View 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. Epub 2007 Apr 19. Erratum in: J Perinatol. 2007 Dec;27(12):808. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	One month postpartum