Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Primary Purpose
Breast Milk Expression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early initiation
Intermediate expression
Late initiation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Milk Expression focused on measuring Breast milk, lactogenesis stage two, premature infant, insufficient milk supply, breast milk expression
Eligibility 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.
Sites / Locations
- University of Florida Shands
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Early initiation
Intermediate expression
Late initiation
Arm Description
Initiation of breast milk expression <1 hour following delivery.
Initiation of milk expression 1-<3 hours following delivery.
Initiation of milk expression >3-6 hours following delivery.
Outcomes
Primary Outcome Measures
Pumped Milk Volume Day 1
Volume of pumped milk on day 1 postpartum
Pumped Milk Volume on Day 2
Volume of breast milk pumped on day 2 postpartum
Pumped Milk Volume Day 3
Volume of milk pumped on day 3 postpartum
Pumped Milk Volume Day 4
Volume of pumped milk on Day 4 postpartum
Pumped Milk Volume on Day 5
Volume of pumped milk on Day 5 postpartum
Pumped Milk Volume Day 6
Volume of pumped milk on Day 6 postpartum
Pumped Milk Volume on Day 7
Volume of milk pumped on day 7 postpartum
Pumped Milk Volume at Day 14
Volume of pumped milk on day 14 postpartum
Pumped Milk Volume Day 21
Volume of milk pumped on day 21 postpartum
Pumped Milk Volume Day 28
Volume of milk pumped on day 28 postpartum
Pumped Milk Volume on Day 35
Volume of milk pumped on day 35 postpartum
Pumped Milk Volume on Day 42
Volume of milk pumped on day 42 postpartum
Secondary Outcome Measures
Hours From Birth to Onset of Lactogenesis Stage 2
Mothers were asked daily concerning a feeling of fullness in their breasts as a measure of onset of lactogenesis stage 2
Days Lactated
Days mothers lactated until infant NICU discharge
Percentage of Feeds Consisting of Mother's Own Milk Week 1
The percentage of feeds consisting of mother's own milk consumed by the participant's infants from day 1-7
Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants
The percentage of feeds consisting of mother's own milk consumed by the participants infants from day 7-14
Percentage of Feeds Consisting of Mother's Own Milk Week 3
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 14-21
Percentage of Feeds Consisting of Mother's Own Milk Week 4
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 21-28
Percentage of Feeds Consisting of Mother's Own Milk Week 5
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 28-35
Percentage of Feeds Consisting of Mother's Own Milk Week 6
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 35-42
Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge
The percentage of feedings consisting of mother's own milk consumed by the participant's infant over the 24 hours period prior to NICU discharge among mothers who continued to lactate
Full Information
NCT ID
NCT01892085
First Posted
June 28, 2013
Last Updated
July 31, 2023
Sponsor
University of Florida
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT01892085
Brief Title
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Official Title
Adequate Breast Milk for Improved Health of Very Low Birth Weight Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Nursing Research (NINR)
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
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.
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
Complete a log with information about their daily breast pumping sessions for 6 weeks.
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.
Episodes of kangaroo care (placing the infant on your bare chest) will be collected.
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
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
Information regarding infant's weekly breast milk intake and breast milk intake at discharge will be collected
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Milk Expression
Keywords
Breast milk, lactogenesis stage two, premature infant, insufficient milk supply, breast milk expression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early initiation
Arm Type
Experimental
Arm Description
Initiation of breast milk expression <1 hour following delivery.
Arm Title
Intermediate expression
Arm Type
Experimental
Arm Description
Initiation of milk expression 1-<3 hours following delivery.
Arm Title
Late initiation
Arm Type
Other
Arm Description
Initiation of milk expression >3-6 hours following delivery.
Intervention Type
Behavioral
Intervention Name(s)
Early initiation
Other Intervention Name(s)
Early initiation of breast milk expressed
Intervention Description
Initiation of breast milk expression <1 hour following delivery.
Intervention Type
Behavioral
Intervention Name(s)
Intermediate expression
Other Intervention Name(s)
Intermediate timing of breast milk expression
Intervention Description
Initiation of milk expression 1-<3 hours following delivery.
Intervention Type
Behavioral
Intervention Name(s)
Late initiation
Other Intervention Name(s)
Late initiation of breast milk expression.
Intervention Description
Initiation of milk expression >3-6 hours following delivery.
Primary Outcome Measure Information:
Title
Pumped Milk Volume Day 1
Description
Volume of pumped milk on day 1 postpartum
Time Frame
Day 1 postpartum
Title
Pumped Milk Volume on Day 2
Description
Volume of breast milk pumped on day 2 postpartum
Time Frame
Day 2 postpartum
Title
Pumped Milk Volume Day 3
Description
Volume of milk pumped on day 3 postpartum
Time Frame
Day 3 postpartum
Title
Pumped Milk Volume Day 4
Description
Volume of pumped milk on Day 4 postpartum
Time Frame
Day 4 postpartum
Title
Pumped Milk Volume on Day 5
Description
Volume of pumped milk on Day 5 postpartum
Time Frame
Day 5 postpartum
Title
Pumped Milk Volume Day 6
Description
Volume of pumped milk on Day 6 postpartum
Time Frame
Day 6 postpartum
Title
Pumped Milk Volume on Day 7
Description
Volume of milk pumped on day 7 postpartum
Time Frame
Day 7 postpartum
Title
Pumped Milk Volume at Day 14
Description
Volume of pumped milk on day 14 postpartum
Time Frame
Day 14 postpartum
Title
Pumped Milk Volume Day 21
Description
Volume of milk pumped on day 21 postpartum
Time Frame
Day 21 postpartum
Title
Pumped Milk Volume Day 28
Description
Volume of milk pumped on day 28 postpartum
Time Frame
Day 28 postpartum
Title
Pumped Milk Volume on Day 35
Description
Volume of milk pumped on day 35 postpartum
Time Frame
Day 35 postpartum
Title
Pumped Milk Volume on Day 42
Description
Volume of milk pumped on day 42 postpartum
Time Frame
Day 42 postpartum
Secondary Outcome Measure Information:
Title
Hours From Birth to Onset of Lactogenesis Stage 2
Description
Mothers were asked daily concerning a feeling of fullness in their breasts as a measure of onset of lactogenesis stage 2
Time Frame
Hours from birth to onset of lactogenesis stage 2
Title
Days Lactated
Description
Days mothers lactated until infant NICU discharge
Time Frame
birth to approximately 3 months
Title
Percentage of Feeds Consisting of Mother's Own Milk Week 1
Description
The percentage of feeds consisting of mother's own milk consumed by the participant's infants from day 1-7
Time Frame
Day 1 to 7
Title
Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants
Description
The percentage of feeds consisting of mother's own milk consumed by the participants infants from day 7-14
Time Frame
Day 7-14
Title
Percentage of Feeds Consisting of Mother's Own Milk Week 3
Description
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 14-21
Time Frame
Day 14-21
Title
Percentage of Feeds Consisting of Mother's Own Milk Week 4
Description
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 21-28
Time Frame
Day 21-28
Title
Percentage of Feeds Consisting of Mother's Own Milk Week 5
Description
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 28-35
Time Frame
Day 28-35
Title
Percentage of Feeds Consisting of Mother's Own Milk Week 6
Description
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 35-42
Time Frame
Day 35-42
Title
Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge
Description
The percentage of feedings consisting of mother's own milk consumed by the participant's infant over the 24 hours period prior to NICU discharge among mothers who continued to lactate
Time Frame
24 hour period prior to NICU discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie A Parker, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Shands
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33913765
Citation
Parker LA, Sullivan S, Cacho N, Krueger C, Mueller M. Effect of Postpartum Depo Medroxyprogesterone Acetate on Lactation in Mothers of Very Low-Birth-Weight Infants. Breastfeed Med. 2021 Oct;16(10):835-842. doi: 10.1089/bfm.2020.0336. Epub 2021 Apr 28.
Results Reference
derived
Learn more about this trial
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
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