Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics

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

Sponsors

Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Source Coordinación de Investigación en Salud, Mexico
Brief 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.

Detailed 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.

Overall Status Completed
Start Date March 2010
Completion Date February 2012
Primary Completion Date February 2012
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of severe necrotizing enterocolitis in preterm newborns <1500g 23 month
Secondary Outcome
Measure Time Frame
Adverse effects with probiotic use in preterm newborns <1500g. 23 month
Enrollment 150
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: probiotics Lactobacillus acidophilus boucardii

Description: 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.

Arm Group Label: probiotics Lactobacillus acidophilus boucardii strain.

Other Name: Gastric tolerance, characteristics of discharges, evolution, reason for discharge, and the development of NEC was monitored.

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 27 Weeks

Maximum Age: 34 Weeks

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Guadalupe Gómez, M.D. Principal Investigator Universidad de Guanajuato
Location
Facility: Instituto Mexicano del seguro social
Location Countries

Mexico

Verification Date

August 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Coordinación de Investigación en Salud, Mexico

Investigator Full Name: Guadalupe Gómez Rodríguez

Investigator Title: neonatologist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: probiotics Lactobacillus acidophilus boucardii strain.

Type: Experimental

Description: Lactobacillus acidophilus boucardii strain was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks .The probiotic presentation used was powder in an envelope with 160mg (Carnot ® Laboratories), scientific products, Mexico, (Registration Number 274M91SSA). This was stored in a dry place at room temperature, avoiding sunlight.

Acronym EPP
Study Design Info

Allocation: Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov