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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
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.
University of Florida Shands
Gainesville, Florida, United States
Pumped Milk Volume Day 1
Volume of pumped milk on day 1 postpartum
Time frame: Day 1 postpartum
Pumped Milk Volume on Day 2
Volume of breast milk pumped on day 2 postpartum
Time frame: Day 2 postpartum
Pumped Milk Volume Day 3
Volume of milk pumped on day 3 postpartum
Time frame: Day 3 postpartum
Pumped Milk Volume Day 4
Volume of pumped milk on Day 4 postpartum
Time frame: Day 4 postpartum
Pumped Milk Volume on Day 5
Volume of pumped milk on Day 5 postpartum
Time frame: Day 5 postpartum
Pumped Milk Volume Day 6
Volume of pumped milk on Day 6 postpartum
Time frame: Day 6 postpartum
Pumped Milk Volume on Day 7
Volume of milk pumped on day 7 postpartum
Time frame: Day 7 postpartum
Pumped Milk Volume at Day 14
Volume of pumped milk on day 14 postpartum
Time frame: Day 14 postpartum
Pumped Milk Volume Day 21
Volume of milk pumped on day 21 postpartum
Time frame: Day 21 postpartum
Pumped Milk Volume Day 28
Volume of milk pumped on day 28 postpartum
Time frame: Day 28 postpartum
Pumped Milk Volume on Day 35
Volume of milk pumped on day 35 postpartum
Time frame: Day 35 postpartum
Pumped Milk Volume on Day 42
Volume of milk pumped on day 42 postpartum
Time frame: Day 42 postpartum
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
Time frame: Hours from birth to onset of lactogenesis stage 2
Days Lactated
Days mothers lactated until infant NICU discharge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: 24 hour period prior to NICU discharge