Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Low Birth Weight

In brief

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 achieve full feeding faster and achieve better weight gain.

Key facts

Study ID

NCT01164124

Run by

Vermont Oxford Network

People needed

101

Starts

2008-02-01

Expected to finish

2009-08-01

Last updated by the study team

2018-07-02

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• known life-threatening congenital anomaly or condition affecting
• gastrointestinal function,
• previous NEC or gastrointestinal perforation,
• previous supplementation with probiotics
• previous enteral feedings

Where it is running

• St. John Hospital & Medical Center — Detroit, Michigan, United States
• Cardinal Glennon Children's Hospital — St Louis, Missouri, United States
• VT Children's at Fletcher-Allen Health Care — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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