Clinical trial NCT01892085: Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Official title: Adequate Breast Milk for Improved Health of Very Low Birth Weight Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Milk Expression
Keywords: Breast milk
lactogenesis stage two
premature infant
insufficient milk supply
breast milk expression
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-07-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Pumped Milk Volume Day 1
timeFrame: Day 1 postpartum
measure: Pumped Milk Volume on Day 2
timeFrame: Day 2 postpartum
measure: Pumped Milk Volume Day 3
timeFrame: Day 3 postpartum
measure: Pumped Milk Volume Day 4
timeFrame: Day 4 postpartum
measure: Pumped Milk Volume on Day 5
timeFrame: Day 5 postpartum
measure: Pumped Milk Volume Day 6
timeFrame: Day 6 postpartum
measure: Pumped Milk Volume on Day 7
timeFrame: Day 7 postpartum
measure: Pumped Milk Volume at Day 14
timeFrame: Day 14 postpartum
measure: Pumped Milk Volume Day 21
timeFrame: Day 21 postpartum
measure: Pumped Milk Volume Day 28
timeFrame: Day 28 postpartum
measure: Pumped Milk Volume on Day 35
timeFrame: Day 35 postpartum
measure: Pumped Milk Volume on Day 42
timeFrame: Day 42 postpartum
Secondary outcomes:
measure: Hours From Birth to Onset of Lactogenesis Stage 2
timeFrame: Hours from birth to onset of lactogenesis stage 2
measure: Days Lactated
timeFrame: birth to approximately 3 months
measure: Percentage of Feeds Consisting of Mother's Own Milk Week 1
timeFrame: Day 1 to 7
measure: Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants
timeFrame: Day 7-14
measure: Percentage of Feeds Consisting of Mother's Own Milk Week 3
timeFrame: Day 14-21
measure: Percentage of Feeds Consisting of Mother's Own Milk Week 4
timeFrame: Day 21-28
measure: Percentage of Feeds Consisting of Mother's Own Milk Week 5
timeFrame: Day 28-35
measure: Percentage of Feeds Consisting of Mother's Own Milk Week 6
timeFrame: Day 35-42
measure: Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge
timeFrame: 24 hour period prior to NICU discharge
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Shands
state: Florida
Study officials:
affiliation: University of Florida
name: Leslie A Parker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parker LA, Sullivan S, Cacho N, Krueger C, Mueller M. Effect of Postpartum Depo Medroxyprogesterone Acetate on Lactation in Mothers of Very Low-Birth-Weight Infants. Breastfeed Med. 2021 Oct;16(10):835-842. doi: 10.1089/bfm.2020.0336. Epub 2021 Apr 28.