The Merit Study (Manual Expression pRemature InfanTs)

NCT02776332 | Unknown

• 1 other identifier: 16-052
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how the duration of manual expression affects milk volumes and levels of breastfeeding self-efficacy in mothers of premature infants. The specific aims of this study are to determine if the duration of manual expression in mothers of premature infants will result in: (a) an increase in breastfeeding self-efficacy (b) a difference in milk volume and (c) a correlation between breastfeeding self-efficacy and milk volume.

Conditions

Breast Milk Expression

Keywords

breastfeeding; premature infants; manual expression

Outcome Measures

Primary Outcomes (1)

• Milk Volume

  Milk volume at each pumping session from day 1-day 14 after delivery

  up to 14 days

Secondary Outcomes (1)

• Level of breastfeeding self-efficacy

  Day 1 and Day 14

Study Arms (2)

3 day group

ACTIVE COMPARATOR

Manual expression for 3 days after delivery Breastfeeding log for 14 days after delivery Video of manual expression for teaching and reinforcement Complete breastfeeding self-efficacy scale at 1 day and 14 days after delivery

Procedure: Manual Expression of Breastmilk

7 day group

ACTIVE COMPARATOR

The 7 day group will manually express for 7 days after delivery. Breastfeeding log for 14 days after delivery Video of manual expression for teaching and reinforcement Complete breastfeeding self-efficacy scale at 1 day and 14 days after delivery follow up phone call at 5 days to encourage continued manual expression

Procedure: Manual Expression of Breastmilk

Interventions

Manual Expression of Breastmilk PROCEDURE

Breastfeeding log for 14 days after delivery Video of manual expression for teaching and reinforcement Complete breastfeeding self-efficacy scale at 1 day and 14 days after delivery

3 day group; 7 day group

Eligibility Criteria

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

You may qualify if:

• Participant delivered premature infant (23-34 weeks gestation)
• Intention to breastfeed
• Infant admitted to NICU

You may not qualify if:

• Premature infant \<23 or \> 34 weeks gestation
• Non-English speaking
• Mother critically ill
• History of breast augmentation surgery
• Time lapse of \> 24 hours since delivery to first expression of breast milk

Sponsors & Collaborators

• St. Louis Children's Hospital: lead

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (9)

• Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.

  PMID: 14649593 BACKGROUND

• Flaherman VJ, Gay B, Scott C, Avins A, Lee KA, Newman TB. Randomised trial comparing hand expression with breast pumping for mothers of term newborns feeding poorly. Arch Dis Child Fetal Neonatal Ed. 2012 Jan;97(1):F18-23. doi: 10.1136/adc.2010.209213. Epub 2011 Jul 11.

  PMID: 21747129 BACKGROUND

• Hill PD, Aldag JC, Zinaman M, Chatterton RT. Predictors of preterm infant feeding methods and perceived insufficient milk supply at week 12 postpartum. J Hum Lact. 2007 Feb;23(1):32-8; quiz 39-43. doi: 10.1177/0890334406297277.

  PMID: 17293549 BACKGROUND

• Hill PD, Aldag JC, Chatterton RT, Zinaman M. Primary and secondary mediators' influence on milk output in lactating mothers of preterm and term infants. J Hum Lact. 2005 May;21(2):138-50. doi: 10.1177/0890334405275403.

  PMID: 15886340 BACKGROUND

• Morton J, Hall JY, Wong RJ, Thairu L, Benitz WE, Rhine WD. Combining hand techniques with electric pumping increases milk production in mothers of preterm infants. J Perinatol. 2009 Nov;29(11):757-64. doi: 10.1038/jp.2009.87. Epub 2009 Jul 2.

  PMID: 19571815 BACKGROUND

• Murase M, Nommsen-Rivers L, Morrow AL, Hatsuno M, Mizuno K, Taki M, Miyazawa T, Nakano Y, Aizawa M, Itabashi K. Predictors of low milk volume among mothers who delivered preterm. J Hum Lact. 2014 Nov;30(4):425-35. doi: 10.1177/0890334414543951. Epub 2014 Jul 25.

  PMID: 25063573 BACKGROUND

• Ohyama M, Watabe H, Hayasaka Y. Manual expression and electric breast pumping in the first 48 h after delivery. Pediatr Int. 2010 Feb;52(1):39-43. doi: 10.1111/j.1442-200X.2009.02910.x. Epub 2009 Jun 11.

  PMID: 19519669 BACKGROUND

• Slusher T, Slusher IL, Biomdo M, Bode-Thomas F, Curtis BA, Meier P. Electric breast pump use increases maternal milk volume in African nurseries. J Trop Pediatr. 2007 Apr;53(2):125-30. doi: 10.1093/tropej/fml066.

  PMID: 17409102 BACKGROUND

• Sisk P, Quandt S, Parson N, Tucker J. Breast milk expression and maintenance in mothers of very low birth weight infants: supports and barriers. J Hum Lact. 2010 Nov;26(4):368-75. doi: 10.1177/0890334410371211. Epub 2010 Oct 7.

  PMID: 20930219 BACKGROUND

MeSH Terms

Conditions

Breast Milk Expression; 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

• Cynthia Russell, PhD

  Univeristy of Missouri Kansas City

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: APN Professional Practice & Systems

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 18, 2016
• Study Start: May 26, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)