Status:
COMPLETED
Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Breast Milk Expression
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01892085
Start Date
November 1 2013
End Date
August 1 2017
Last Update
August 24 2023
Active Locations (1)
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1
University of Florida Shands
Gainesville, Florida, United States, 32605