An interventional study of Probiotic Supplemented Group and Control Group in Feeding Tolerance, sponsored by Mercy Health System. Terminated at 1 site in United States. Open to participants aged Up to 14 Days. Per ClinicalTrials.gov, last updated 2018-10-11.
Sponsored by Mercy Health System · Not applicable, Interventional, and Supportive care
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).
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.
445 studies on the registry are indexed under Birth Weight; 36 are open to participants now.
This study's enrollment of 133 is above the median of 110 across 297 interventional studies indexed under Birth Weight.
Browse Birth Weight studies →Mercy Health System is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
500,000,0000 cells of Lactobacillus GG (utilizing either Culturelle for Kids or Kids Culturelle preparation) and 500,000,000 cells of Bifidobacterium Infantis (utilizing Align capsule) diluted in 3 ml breastmilk/formula and administered enterally from first day of enteral feeds until term gestation/discharge/transfer/death (whichever occurs first) every day infant is receives enteral feedings
Dietary Supplement: Probiotic Supplemented Group
3 ml enteral feeding of breastmilk/formula administered once daily in addition to regularly prescribed enteral feedings from day of first feeding until term gestation/discharge/transfer/death (which ever occurs first) and administered every day that infant receives enteral feedings
Dietary Supplement: Control Group
Also known as: Culture for Kids, Kids Culturelle, Align, Lactobacillus GG, Bifidobacter Infantis
Also known as: Breastmilk, Formula
Feeding Tolerance
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
Time frame: Evaluated on a daily basis until hospital discharge/transfer/death up until one year of age
Necrotizing Enterocolitis (Bell's Stage 2 or greater)
Time frame: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until 1 year of age
Culture proven sepsis without Necrotizing Enterocolitis
Time frame: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Chronic Lung Disease
Time frame: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Periventricular Leukomalacia
Time frame: Infant's entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Mortality
Time frame: Infant's entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Intraventricular Hemorrhage
Time frame: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Daily weight gain in grams
Time frame: Measured daily until time of hospital discharge/transfer/death up until one year of age
Discharge weight measured and expressed by percentile of growth for age
Time frame: Assessed at the time of discharge/transfer/death up until one year of age
Length of Stay
Time frame: Measured at time of discharge/transfer/death up until one year of age
Plan to share: No
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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