Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using

Status Completed

Clinical Trial Summary

The purpose of this study is to know the effects of probiotics on the incidence of Necrotizing Enterocolitis (NEC) in preterm infants less than 1500 g.

Clinical Trial Description

The investigators performed a clinical, randomized, double-blind trial in preterm infants <1500g from March 1, 2010 to February 28, 2012. Group A received enteral stimulation trophic five days and later increments 20ml/k/day of breast milk or formula for premature; the group B apart from the above the probiotic Lactobacillus acidophilus (boucardii strain) 1 X109 colonic forming unit (CFU)/ day for 4 weeks was added. Gastric tolerance, evolution, reason for discharge, and the development of Necrotizing enterocolitis was monitored. The diagnosis of Necrotizing enterocolitis was made by the treating physician according to Bell's criteria and was blinded to group assignments.The formulas were prepared by one of the investigators according to the group each patient was assigned. Using sterile technique, the probiotic with 1x109 (CFU) Lactobacillus acidophilus (boucardii strain) was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks to fresh supplement breast milk or formula for preterm infants. In case of control group only breast milk or formula for preterm infants was used.

All formulas were labeled for each patient and were delivered to the nurse in charge of infant feeding at 9:00 and 21:00 h.

Characteristics of Sample size and statistical analysis:

Sample size showed that the investigators needed 190 total preterm infants, based on the expected 50% decrease in the incidence of severe necrotizing enterocolitis in preterm neonates who received probiotics compared with control group with α 0.05 and β 0.20. Student´s t test or Mann Whitney U test were performed for mean differences regarding the general characteristics in the two study groups, Chi square or Fisher´s test for differences in proportions for mortality and complications between groups. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02226263
Study type	Interventional
Source	Coordinación de Investigación en Salud, Mexico
Contact
Status	Completed
Phase	Phase 2
Start date	March 2010
Completion date	February 2012

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics — EPP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms