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NCT01892085 · ClinicalTrials.gov registry record · NA
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 180
- Enrollment target
NCT01892085 is a NA study that has completed, run by University of Florida. The registered enrollment target is 180 participants.
The verdict
NCT01892085, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Early initiation
- BEHAVIORAL Intermediate expression
- BEHAVIORAL Late initiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01892085
The ClinicalTrials.gov registry entry for NCT01892085 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Early initiation is the first listed.
NCT01892085 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01892085 about?
NCT01892085 is a clinical study titled "Early Initiation of Milk Expression in Mothers of Very Low Birth Weight 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...
What is the current status of trial NCT01892085?
This trial is currently completed. It is a NA study. The enrollment target is 180 participants. The study started on 2013-11. Estimated completion is 2017-08.
What interventions are being tested in trial NCT01892085?
The interventions under investigation include: Early initiation (BEHAVIORAL), Intermediate expression (BEHAVIORAL), Late initiation (BEHAVIORAL).
Who is sponsoring clinical trial NCT01892085?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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