NCT01788761

The Effects of Probiotic Supplementation on Extremely Low Birthweight Infants

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Mercy Health System · Network
• Sex: All
• Age: 14 Days
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The purpose of this research study is to investigate the effect of the administration of the nutritional supplements, Culturelle for Kids/Kids Culturelle in combination with Align, containing the Probiotics Lactobacillus GG and Bifidobacterium Infantis, on feeding tolerance (as determined by the number of days infant is without enteral feedings due to feeding intolerance, number of days infant requires supplemental hyperalimentation/intravenous fluids for nutritional support and number of days to achieve full enteral feedings) in high risk extremely low birth weight infants.

Conditions

• Feeding Tolerance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic Supplemented Group
DIETARY_SUPPLEMENT	Control Group

Timeline

• Start date: 2012-07-01
• Primary completion: 2018-07-11
• Completion: 2018-07-11
• First posted: 2013-02-11
• Last updated: 2018-10-11

Locations

1 site across 1 country: United States