Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01892085
First received: June 28, 2013
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk "comes in") and decreased breast milk production. Several studies have linked earlier initiation of breast milk expression following delivery with a greater milk production. However, none conclusively determined the optimal timing of breast milk expression. As a result these mothers continue to struggle with inadequate breast milk production. This study will follow 180 mothers of premature infants for 6 weeks following delivery to test

Earlier initiation of breast milk expression following delivery is associated with (1) an earlier lactogenesis stage II, (2) greater volume of breast milk production during the first 6 weeks, (3) improved short-term infant health outcomes and (4) women who deliver at an earlier gestation will have decreased milk production and a later lactogenesis stage II. Following stratification according to the gestational age of the infant (23-27 weeks vs. 28-32 weeks), eligible women will be randomly assigned to one of three groups and instructed to start mechanically expressing their r breasts, either in the first hour, 1-3 hours or 3-6 hours following delivery. The timing of lactogenesis stage II will be documented, and the volume of breast milk produced will continue to be measured for the first 6 weeks following delivery and at discharge. Infant nutritional outcomes will be measured throughout the 6-week study. The impact of the differences in timing of initiation of milk expression following delivery on timing of lactogenesis stage II, milk volume, short term nutritional outcomes, amount of breast milk feedings at discharge, and impact of gestational age on milk volume and lactogenesis stage II will be determined.


Condition Intervention
Breast Milk Expression
Behavioral: Early initiation
Behavioral: Intermediate expression
Behavioral: Late initiation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adequate Breast Milk for Improved Health of Very Low Birth Weight Preterm Infants

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • The volume of breast milk [ Time Frame: Change in baseline to 6 weeks ] [ Designated as safety issue: No ]
    Volume of breast milk will be measured at days 1-7, 14,21,28,35 and 42


Secondary Outcome Measures:
  • Timing of lactogenesis stage 2 [ Time Frame: Change from baseline to week 2 ] [ Designated as safety issue: No ]
    Mothers will be asked daily concerning a feeling of fullness in their breasts

  • Weekly percentage of infant breast milk intake [ Time Frame: Change in baseline to 6 weeks ] [ Designated as safety issue: No ]
    The percentage of breast milk consumed by the infant weekly will be calculated

  • Percentage of breast milk feedings of infant at discharge [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    The percentage of breast milk the infant receives on day of discharge will be calculated


Estimated Enrollment: 180
Study Start Date: November 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early initiation
Initiation of breast milk expression <1 hour following delivery.
Behavioral: Early initiation
Initiation of breast milk expression <1 hour following delivery.
Other Name: Early initiation of breast milk expressed
Experimental: Intermediate expression
Initiation of milk expression 1-<3 hours following delivery.
Behavioral: Intermediate expression
Initiation of milk expression 1-<3 hours following delivery.
Other Name: Intermediate timing of breast milk expression
Late initiation
Initiation of milk expression >3-6 hours following delivery.
Behavioral: Late initiation
Initiation of milk expression >3-6 hours following delivery.
Other Name: Late initiation of breast milk expression.

Detailed Description:

Mothers will be randomly assigned to one of three groups. Group 1 will begin pumping their breasts with the assistance of medical or nursing personnel within 60 minutes following delivery. Group 2 will begin pumping their breasts with the assistance of medical or nursing personnel within 1- less than 3 hours following delivery. Group 3 will begin pumping their breasts with the assistance of medical or nursing personnel 3-6 hours following delivery. Mothers will also do the following

  1. Complete a log with information about their daily breast pumping sessions for 6 weeks.
  2. Bring your breast milk to the neonatal intensive care unit when they visit and the milk will be weighed to determine the volume of milk.
  3. Episodes of kangaroo care (placing the infant on your bare chest) will be collected.
  4. Receive a call beginning the day after you delivery and then daily until their milk comes in to ask about a feeling of fullness in their breasts.

In addition the following will be done

  1. If their infant breastfeeds, he/she will be weighed before and after feeding to collect data on how much milk he/she ate from the breast
  2. Information regarding infant's weekly breast milk intake and breast milk intake at discharge will be collected
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1) at least 18 years of age,
  • 2) English or Spanish-speaking,
  • 3) stated intent to breastfeed,
  • 4) anticipating the birth of a very low birth weight infant (≤1500 grams) between 23-32 weeks gestation.

Exclusion Criteria:

  • 1) known illicit maternal drug use,
  • 2) history of breast reduction or augmentation,
  • 3) positive HIV status,
  • 4) mother not transported to recovery by 45 minutes following delivery or
  • 5) infant not expected to live over 2 weeks following delivery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892085

Contacts
Contact: Leslie A Parker, PhD 352 215 9360 parkela@ufl.edu

Locations
United States, Florida
University of Florida Shands Recruiting
Gainesville, Florida, United States, 32605
Contact: Leslie A Parker, PhD    352-215-9360    parkela@ufl.edu   
Principal Investigator: Leslie A Parker, PhD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Leslie A Parker, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01892085     History of Changes
Other Study ID Numbers: 2012-00071, 1R15NR013566-01A1
Study First Received: June 28, 2013
Last Updated: May 8, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Florida:
Breast milk
lactogenesis stage two
premature infant
insufficient milk supply
breast milk expression

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014