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

Study Overview
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Brief Summary
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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
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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

Official Title
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Adequate Breast Milk for Improved Health of Very Low Birth Weight Preterm Infants

Conditions
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Breast Milk Expression

Intervention / Treatment
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* Behavioral: Early initiation
* Behavioral: Intermediate expression
* Behavioral: Late initiation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early initiation<br>Initiation of breast milk expression <1 hour following delivery. | Behavioral: Early initiation<br>* Initiation of breast milk expression <1 hour following delivery.<br>* Other names: Early initiation of breast milk expressed;|
| Experimental: Intermediate expression<br>Initiation of milk expression 1-<3 hours following delivery. | Behavioral: Intermediate expression<br>* Initiation of milk expression 1-<3 hours following delivery.<br>* Other names: Intermediate timing of breast milk expression;|
| Other: Late initiation<br>Initiation of milk expression >3-6 hours following delivery. | Behavioral: Late initiation<br>* Initiation of milk expression >3-6 hours following delivery.<br>* Other names: Late initiation of breast milk expression.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pumped Milk Volume Day 1 | Volume of pumped milk on day 1 postpartum | Day 1 postpartum | 
| Pumped Milk Volume on Day 2 | Volume of breast milk pumped on day 2 postpartum | Day 2 postpartum | 
| Pumped Milk Volume Day 3 | Volume of milk pumped on day 3 postpartum | Day 3 postpartum | 
| Pumped Milk Volume Day 4 | Volume of pumped milk on Day 4 postpartum | Day 4 postpartum | 
| Pumped Milk Volume on Day 5 | Volume of pumped milk on Day 5 postpartum | Day 5 postpartum | 
| Pumped Milk Volume Day 6 | Volume of pumped milk on Day 6 postpartum | Day 6 postpartum | 
| Pumped Milk Volume on Day 7 | Volume of milk pumped on day 7 postpartum | Day 7 postpartum | 
| Pumped Milk Volume at Day 14 | Volume of pumped milk on day 14 postpartum | Day 14 postpartum | 
| Pumped Milk Volume Day 21 | Volume of milk pumped on day 21 postpartum | Day 21 postpartum | 
| Pumped Milk Volume Day 28 | Volume of milk pumped on day 28 postpartum | Day 28 postpartum | 
| Pumped Milk Volume on Day 35 | Volume of milk pumped on day 35 postpartum | Day 35 postpartum | 
| Pumped Milk Volume on Day 42 | 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 | 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 | Days mothers lactated until infant NICU discharge | birth to approximately 3 months | 
| 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 | Day 1 to 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 | 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 | 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 | 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 | 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 | 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 | 24 hour period prior to NICU discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast milk, lactogenesis stage two, premature infant, insufficient milk supply, breast milk expression