- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01892085
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Adequate Breast Milk for Improved Health of Very Low Birth Weight Preterm Infants
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Gainesville, Florida, United States, 32605
- University of Florida Shands
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early initiation
Initiation of breast milk expression <1 hour following delivery.
|
Initiation of breast milk expression <1 hour following delivery.
Other Names:
|
Experimental: Intermediate expression
Initiation of milk expression 1-<3 hours following delivery.
|
Initiation of milk expression 1-<3 hours following delivery.
Other Names:
|
Other: Late initiation
Initiation of milk expression >3-6 hours following delivery.
|
Initiation of milk expression >3-6 hours following delivery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pumped Milk Volume Day 1
Time Frame: Day 1 postpartum
|
Volume of pumped milk on day 1 postpartum
|
Day 1 postpartum
|
Pumped Milk Volume on Day 2
Time Frame: Day 2 postpartum
|
Volume of breast milk pumped on day 2 postpartum
|
Day 2 postpartum
|
Pumped Milk Volume Day 3
Time Frame: Day 3 postpartum
|
Volume of milk pumped on day 3 postpartum
|
Day 3 postpartum
|
Pumped Milk Volume Day 4
Time Frame: Day 4 postpartum
|
Volume of pumped milk on Day 4 postpartum
|
Day 4 postpartum
|
Pumped Milk Volume on Day 5
Time Frame: Day 5 postpartum
|
Volume of pumped milk on Day 5 postpartum
|
Day 5 postpartum
|
Pumped Milk Volume Day 6
Time Frame: Day 6 postpartum
|
Volume of pumped milk on Day 6 postpartum
|
Day 6 postpartum
|
Pumped Milk Volume on Day 7
Time Frame: Day 7 postpartum
|
Volume of milk pumped on day 7 postpartum
|
Day 7 postpartum
|
Pumped Milk Volume at Day 14
Time Frame: Day 14 postpartum
|
Volume of pumped milk on day 14 postpartum
|
Day 14 postpartum
|
Pumped Milk Volume Day 21
Time Frame: Day 21 postpartum
|
Volume of milk pumped on day 21 postpartum
|
Day 21 postpartum
|
Pumped Milk Volume Day 28
Time Frame: Day 28 postpartum
|
Volume of milk pumped on day 28 postpartum
|
Day 28 postpartum
|
Pumped Milk Volume on Day 35
Time Frame: Day 35 postpartum
|
Volume of milk pumped on day 35 postpartum
|
Day 35 postpartum
|
Pumped Milk Volume on Day 42
Time Frame: Day 42 postpartum
|
Volume of milk pumped on day 42 postpartum
|
Day 42 postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hours From Birth to Onset of Lactogenesis Stage 2
Time Frame: 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
|
Hours from birth to onset of lactogenesis stage 2
|
Days Lactated
Time Frame: birth to approximately 3 months
|
Days mothers lactated until infant NICU discharge
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birth to approximately 3 months
|
Percentage of Feeds Consisting of Mother's Own Milk Week 1
Time Frame: Day 1 to 7
|
The percentage of feeds consisting of mother's own milk consumed by the participant's infants from day 1-7
|
Day 1 to 7
|
Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants
Time Frame: Day 7-14
|
The percentage of feeds consisting of mother's own milk consumed by the participants infants from day 7-14
|
Day 7-14
|
Percentage of Feeds Consisting of Mother's Own Milk Week 3
Time Frame: Day 14-21
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The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 14-21
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Day 14-21
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Percentage of Feeds Consisting of Mother's Own Milk Week 4
Time Frame: Day 21-28
|
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 21-28
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Day 21-28
|
Percentage of Feeds Consisting of Mother's Own Milk Week 5
Time Frame: Day 28-35
|
The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 28-35
|
Day 28-35
|
Percentage of Feeds Consisting of Mother's Own Milk Week 6
Time Frame: Day 35-42
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The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 35-42
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Day 35-42
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Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge
Time Frame: 24 hour period prior to NICU discharge
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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
|
24 hour period prior to NICU discharge
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leslie A Parker, PhD, University of Florida
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-00071-N
- 1R15NR013566-01A1 (U.S. NIH Grant/Contract)
- IRB201200071 (Other Identifier: Univeristy of Florida)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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