Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics

Infectious Diseases Clinical Trial

— EPP  

Official title:

Incidence of Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics Lactobacillus Boucardii.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226263
• Other study ID #: R-2010-1002-12
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2014
• Last updated: August 25, 2014
• Start date: March 2010
• Est. completion date: February 2012

Study information

• Verified date: August 2014
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 27 Weeks to 34 Weeks

Eligibility

Inclusion Criteria:

• We studied 150 preterm newborns <1500gr who were recruited on the day that began enteral feeding according to the decision of the treating physician.

Exclusion Criteria:

• Preterm infants > 1500g with Apgar score <6 at 5 minutes, gastrointestinal malformations, fetopathies, patent ductus arteriosis with hemodynamic decompensation, asphyxia, and NEC suspected as classified by Bell were excluded from the study.

Related Conditions & MeSH terms

• Communicable Diseases
• Enterocolitis
• Enterocolitis, Necrotizing
• Infection
• Infectious Diseases

Intervention

Dietary Supplement:
• probiotics Lactobacillus acidophilus boucardii
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.

Locations

Country	Name	City	State
Mexico	Instituto Mexicano del seguro social	Leon	Guanajuato

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnosis the Necrotizing Enterocolitis (NEC)	Our primary outcome was the presence of severe (NEC) monitored by the Bell´s criteria; secondarily we evaluated the presence of sepsis diagnosed with clinical signs of systemic inflammatory response and positive blood culture,	23 month
Primary	Incidence of severe necrotizing enterocolitis in preterm newborns <1500g	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 boucardii 1 X109 (CFU) / day for 4 weeks was added.	23 month
Secondary	Adverse effects with probiotic use in preterm newborns <1500g.	The amount of food was increased slowly if tolerated according to the Clinical Practice Guidelines for enteral feeding preterm in our hospital, enteral feeding was interrupted if there was any sign of intolerance such as vomiting, presence of bile or blood content by probe orogastric, bloating, or bloody stools which were assessed and recorded daily.Our primary outcome was the presence of severe necrotizing enterocolitis (NEC) monitored by the Bell´s criteria; secondarily we evaluated the presence of sepsis diagnosed with clinical signs of systemic inflammatory response and positive blood culture.	23 month