Status:
COMPLETED
Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants
Lead Sponsor:
Vermont Oxford Network
Collaborating Sponsors:
University of Vermont
St. Louis University
Conditions:
Low Birth Weight
Eligibility:
All Genders
1-14 years
Phase:
PHASE2
PHASE3
Brief Summary
The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her ach...
Detailed Description
The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her ach...
Eligibility Criteria
Inclusion
- birth weight less than or equal to 1000 grams,
- appropriately grown for gestational age,
- age 1 to 14 days inclusive,
- intention to start enteral feeds,
- written informed consent obtained
Exclusion
- known life-threatening congenital anomaly or condition affecting
- gastrointestinal function,
- previous NEC or gastrointestinal perforation,
- previous supplementation with probiotics
- previous enteral feedings
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01164124
Start Date
February 1 2008
End Date
August 1 2009
Last Update
July 2 2018
Active Locations (3)
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1
St. John Hospital & Medical Center
Detroit, Michigan, United States, 48236
2
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States, 63104-1095
3
VT Children's at Fletcher-Allen Health Care
Burlington, Vermont, United States, 05401