CompletedNot Applicable

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

United States180 participantsStarted 2013-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pumped Milk Volume Day 1

Timeframe: Day 1 postpartum

Pumped Milk Volume on Day 2

Timeframe: Day 2 postpartum

Pumped Milk Volume Day 3

Timeframe: Day 3 postpartum

Pumped Milk Volume Day 4

Timeframe: Day 4 postpartum

Pumped Milk Volume on Day 5

Timeframe: Day 5 postpartum

Pumped Milk Volume Day 6

Timeframe: Day 6 postpartum

Pumped Milk Volume on Day 7

Timeframe: Day 7 postpartum

Pumped Milk Volume at Day 14

Timeframe: Day 14 postpartum

Trial details

NCT IDNCT01892085

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08

Results submitted2023-04-11

View on ClinicalTrials.gov More Breast Milk Expression trials