CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
Early initiation +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01892085
NCT01892085N/ACompleted

Adequate Breast Milk for Improved Health of Very Low Birth Weight Preterm Infants

University of Florida·interventional·Posted Jul 3, 2013·Updated Aug 24, 2023

In Brief

A clinical study evaluating Early initiation, Intermediate expression, and 1 other intervention for Breast Milk Expression. Completed, enrolled 180 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 3, 2013
Enrollment StartNov 1, 2013
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.0 years ago

Interventions

Early initiationbehavioral

Initiation of breast milk expression \<1 hour following delivery.

Intermediate expressionbehavioral

Initiation of milk expression 1-\<3 hours following delivery.

Late initiationbehavioral

Initiation of milk expression \>3-6 hours following delivery.