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

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ClinicalTrials.gov Identifier: NCT02226263
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Sponsor:
Information provided by (Responsible Party):
Guadalupe Gómez Rodríguez, 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.

Condition or disease Intervention/treatment Phase
Infectious Diseases Dietary Supplement: probiotics Lactobacillus acidophilus boucardii Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Incidence of Severe Necrotizing Enterocolitis in Preterm Newborns <1500g Using Probiotics Lactobacillus Boucardii.
Study Start Date : March 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012


Arm Intervention/treatment
Experimental: probiotics Lactobacillus acidophilus boucardii strain.
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.
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.
Other Name: Gastric tolerance, characteristics of discharges, evolution, reason for discharge, and the development of NEC was monitored.




Primary Outcome Measures :
  1. Incidence of severe necrotizing enterocolitis in preterm newborns <1500g [ Time Frame: 23 month ]
    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.


Secondary Outcome Measures :
  1. Adverse effects with probiotic use in preterm newborns <1500g. [ Time Frame: 23 month ]
    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.


Other Outcome Measures:
  1. Diagnosis the Necrotizing Enterocolitis (NEC) [ Time Frame: 23 month ]
    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,



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Ages Eligible for Study:   27 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226263


Locations
Mexico
Instituto Mexicano del seguro social
Leon, Guanajuato, Mexico, 37000
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
Principal Investigator: Guadalupe Gómez, M.D. Universidad de Guanajuato

Responsible Party: Guadalupe Gómez Rodríguez, neonatologist, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT02226263     History of Changes
Other Study ID Numbers: R-2010-1002-12
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014

Keywords provided by Guadalupe Gómez Rodríguez, Coordinación de Investigación en Salud, Mexico:
Necrotizing enterocolitis
Probiotics
Preterm newborns

Additional relevant MeSH terms:
Enterocolitis
Communicable Diseases
Infection
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases