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

Not Applicable

Completed

• Conditions: Breast Milk Expression
• Interventions: Behavioral: Early initiation; Behavioral: Late initiation; Behavioral: Intermediate expression

• Registration Number: NCT01892085
• Lead Sponsor: University of Florida

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-06-28
• Study First Submitted QC: 2013-06-28
• Study First Posted: 2013-07-03
• Study Start: 2013-11
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Results First Submitted: 2023-04-11
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-31
• Last Update Submitted: 2023-07-31
• Results First Posted: 2023-08-24
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early initiation	Early initiation	Initiation of breast milk expression \<1 hour following delivery.
Late initiation	Late initiation	Initiation of milk expression \>3-6 hours following delivery.
Intermediate expression	Intermediate expression	Initiation of milk expression 1-\<3 hours following delivery.

Primary Outcome Measures

Name	Time	Method
Pumped Milk Volume Day 3	Day 3 postpartum	Volume of milk pumped on day 3 postpartum
Pumped Milk Volume Day 1	Day 1 postpartum	Volume of pumped milk on day 1 postpartum
Pumped Milk Volume on Day 5	Day 5 postpartum	Volume of pumped milk on Day 5 postpartum
Pumped Milk Volume Day 21	Day 21 postpartum	Volume of milk pumped on day 21 postpartum
Pumped Milk Volume at Day 14	Day 14 postpartum	Volume of pumped milk on day 14 postpartum
Pumped Milk Volume Day 28	Day 28 postpartum	Volume of milk pumped on day 28 postpartum
Pumped Milk Volume Day 6	Day 6 postpartum	Volume of pumped milk on Day 6 postpartum
Pumped Milk Volume Day 4	Day 4 postpartum	Volume of pumped milk on Day 4 postpartum
Pumped Milk Volume on Day 7	Day 7 postpartum	Volume of milk pumped on day 7 postpartum
Pumped Milk Volume on Day 42	Day 42 postpartum	Volume of milk pumped on day 42 postpartum
Pumped Milk Volume on Day 2	Day 2 postpartum	Volume of breast milk pumped on day 2 postpartum
Pumped Milk Volume on Day 35	Day 35 postpartum	Volume of milk pumped on day 35 postpartum

Secondary Outcome Measures

Name	Time	Method
Days Lactated	birth to approximately 3 months	Days mothers lactated until infant NICU discharge
Hours From Birth to Onset of Lactogenesis Stage 2	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
Percentage of Feeds Consisting of Mother's Own Milk Week 1	Day 1 to 7	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 3	Day 14-21	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 2 Consumed by Infants	Day 7-14	The percentage of feeds consisting of mother's own milk consumed by the participants infants from day 7-14
Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge	24 hour period prior to 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
Percentage of Feeds Consisting of Mother's Own Milk Week 4	Day 21-28	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 6	Day 35-42	The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 35-42
Percentage of Feeds Consisting of Mother's Own Milk Week 5	Day 28-35	The percentage of feeds consisting of mother's own milk consumed by the participant's infant from day 28-35

Trial Locations

Locations (1)

University of Florida Shands; 🇺🇸 Gainesville, Florida, United States