N/A N=90 Randomized Double-blind Prevention

Prevention of Necrotizing Enterocolitis of Premature Newborns Under Less Than 1500 g Using Probiotics

Infectious Diseases

Bottom Line

View on ClinicalTrials.gov: NCT02245815 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Number of Patients With (NEC) — 0; 1 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: use probiotics boucardii (Dietary_supplement); use probiotics Multi-species (Dietary_supplement)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Coordinación de Investigación en Salud, Mexico
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With (NEC)	0; 1	—

Summary

The purpose of this study is to evaluate the incidence of necrotizing enterocolitis and its effect over the secreting immunoglobulin A in the feces with the use of probiotics of the strain Lactobacillus acidophilus boucardii vs. Multispecies in premature newborns weighting less than 1500 g.

Eligibility Criteria

Inclusion Criteria

All of the premature newborns of 34 weeks of gestational age, and with a weight between 700 to 1500 g. that are admitted in the Neonatal Intensive Care Unit or the Neonatology Department that have no contraindication for oral intake in the first 7 days of life. Must not have been diagnosed of sepsis of early onset, prenatal asphyxia, patent ductus arterious with hemodynamic repercussion, major congenital malformations. In all cases the parents or legal guardian must sign the informed consent.

Exclusion Criteria

All preterm newborns younger than 34 weeks of gestational age that develop any disease different of (NEC) that require to stop the enteral feeding for more than seven days or whose parents or legal guardians revoke the informed consent form.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02245815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.