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

Completed · Not applicable

Conditions studied: Breast Milk Expression

In brief

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.

Key facts

Study ID

NCT01892085

Run by

University of Florida

People needed

180

Starts

2013-11-01

Expected to finish

2017-08-01

Last updated by the study team

2023-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Florida Shands — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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