The Effects of Probiotic Supplementation on Extremely Low Birthweight Infants
Stopped early · Not applicable
Conditions studied: Feeding Tolerance
In brief
This is a research study that will look at the effects of giving two nutritional supplements on extremely low birth infants (infants weighing less than 1000 grams or weighing less than approximately 2 lbs 3 1/2 ounces at birth). The nutritional supplements that will be studied are Culturelle for Kids/Culturelle Kids and Align. They are nutritional supplements that each contain a different probiotic. In this study the investigators will mainly be looking at the effect that these supplements may have on how well babies tolerate their feedings and how long they require supplemental intravenous fluids for nutritional support. The investigators will also, however, look at many other factors such as rate of growth, rates of infection, survival rate and the length of time the infant needs to be in the hospital. The investigators will also look at its effect on conditions/complications of prematurity such as bronchopulmonary dysplasia and chronic lung disease (chronic diseases of the lung associated with prematurity), necrotizing enterocolitis and intestinal perforations (serious diseases of the infant's intestines), retinopathy of prematurity (eye disease associated with prematurity), intracranial hemorrhage (bleeding into the brain) and patent ductus arteriosus (a blood vessel connecting two main blood vessels coming out of the heart that does not close spontaneously (by itself).
Key facts
- Study ID
- NCT01788761
- Run by
- Mercy Health System
- People needed
- 133
- Starts
- 2012-07-01
- Expected to finish
- 2018-07-11
- Last updated by the study team
- 2018-10-11
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Birthweight between 500-999 grams
- Apgar score greater than or equal to 3 at 5 minutes
- Infant free from any known major congenital anomalies or chromosomal/genetic anomalies
- Infant without any known cyanotic or complex congenital heart disease
- Infant NPO or on trophic enteral feedings than have been started less than 24 hours previously
- Infant without prior history of necrotizing enterocolitis or gastrointestinal perforation
- Infant without previous exposure to probiotics
- Infant that will be ready to start trophic feedings within the first 14 days of life
- Infant less than or equal to 14 days of age
- Infant born to HIV negative mother
- Written informed consent obtained from mother
You may not qualify if…
- Infant born to HIV positive mother
- Infant with history of prior probiotic exposure
- Infant greater than 14 days of age
- Infant on enteral feedings for greater than 24 hours
- Infant with major congenital anomaly/chromosomal or genetic anomaly
- Infant with cyanotic/complex congenital heart disease
- Infant with previous gastrointestinal perforation/necrotizing enterocolitis
- 5 minute Apgar score < 3
Where it is running
- Rockford Memorial Hospital — Rockford, Illinois, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.