Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Status: | Completed |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/29/2018 |
Start Date: | November 2013 |
End Date: | August 2017 |
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.
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.
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
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
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.
We found this trial at
1
site
Gainesville, Florida 32611
Principal Investigator: Leslie A Parker, PhD
Phone: 352-215-9360
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